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148 Study Matches

Effect of Clear Aligner Attachment Size on Extrusion of Maxillary Lateral Incisors

Alexis Catalano - catalanoam2@vcu.edu

NCT06814262
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Inclusion Criteria:
* Patients treated with either Comprehensive Invisalign or Invisalign Teen treatment * The maxillary arch has less than 6 mm of crowding or spacing * Maxillary lateral incisors have a minimum of 0.3 mm of extrusion prescribed in the Tooth Movement Table on the Invisalign ClinCheck for the first set of aligners * Maxillary lateral incisors within a normal range of bucco-lingual inclination * Patients 12 years of age or older and either the patient or legal guardian are able to give consent * Patients confirm good compliance throughout the study period
Exclusion Criteria:
* Patients do not complete all aligners in the first phase as prescribed * Poor compliance recorded for aligner wear * Restorations placed or oral surgery completed prior to final scan * Midcourse intervention to improve tracking such as a bootstrap * Maxillary lateral incisors not tracking and noted by minimum of 1 mm of aligner material incisally displaced when aligner fully seated * Treatment plans include surgery or extractions * Maxillary lateral incisors with pathology and restorations * Missing teeth other than third molars * Patients with anterior crossbite
DEVICE: Corresponding treatment order in the prescription with Align Technology, DEVICE: Superimposition of final and initial positions of lateral incisors: Predicted model, DEVICE: Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x3mm aligners, DEVICE: Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x4mm aligners, DEVICE: Superimposition of final and initial positions of lateral incisors: Gingivally beveled 1x1x5mm aligners
Orthodontic Appliance Complication
Extrusion of Maxillary Lateral Incisors, Clear Aligner Attachment
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Virginia Commonwealth University Richmond, Virginia Alexis Catalano - (catalanoam2@vcu.edu) Steven Lindauer - (sjlindau@vcu.edu)

A Study With Tovorafenib (DAY101) as a Treatment Option for Progressive, Relapsed, or Refractory Langerhans Cell Histiocytosis

ctrrecruit@vcu.edu

NCT05828069
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Inclusion Criteria:
* 180 days- \< 22 years (at time of study enrollment) * Patient must have a body surface area of ≥ 0.3 m\^2 * Patients with progressive, relapsed, or recurrent LCH with measurable disease at study entry * Patients must have had histologic verification of LCH (from either original diagnosis or relapse/progression) at the time of study entry * Tissue confirmation of relapse is recommended but not required. * Pathology report must be submitted for central confirmation of diagnosis within 7 days of enrollment. * Formalin-fixed paraffin-embedded (FFPE) blocks or unstained slides (initial diagnosis and/or subsequent biopsies) will be required for retrospective central confirmation of diagnosis and molecular studies * Patients with mixed histiocytic disorders (e.g. LCH with juvenile xanthogranuloma) may be included * Patients must have measurable disease * Patients must have progressive or refractory disease or experience relapse after at least one previous systemic treatment strategy * Pathogenic somatic mutation detected in genes encoding tyrosine kinase receptors (CSFR1, ERBB3 or ALK), RAS or RAF (may be from original or subsequent biopsy or peripheral blood/bone marrow aspirate). Clinical mutation reports may include quantitative polymerase chain reaction (PCR) (e.g. BRAFV600E) and/or Sanger or next generation sequencing. Immunohistochemistry (e.g. VE1 antibody for BRAFV600E) alone is not sufficient * Participant must be able to take an enteral dose and formulation of medication. Study medication is only available as an oral suspension or tablet, which may be taken by mouth or other enteral route such as nasogastric, jejunostomy, or gastric tube * Karnofsky \>= 50% for patients \> 16 years of age and Lansky \>= 50% for patients =\< 16 years of age * Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1 or 2. Use Karnofsky for patients \> 16 years of age and Lansky for patients =\< 16 years of age * Myelosuppressive chemotherapy: Patients must not have received within 14 days of entry onto this study * Investigational agent or any other anticancer therapy not defined above: Patients must not have received any investigational agent or any other anticancer therapy (including MAPK pathway inhibitor) for at least 14 days prior to planned start of tovorafenib (DAY101) * Radiation therapy (RT): Patient must not have received RT within 2 weeks after the last dose fraction of RT * Patients must have fully recovered from any prior surgery * Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, targeted inhibitor, and/or radiotherapy with toxicities reduced to grade 1 or less (Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0) * Steroids: =\< 0.5 mg/kg/day of prednisone equivalent (maximum 20 mg/day) averaged during the month prior to study enrollment is permissible * Strong inducers or inhibitors of CYP2C8 are prohibited for 14 days before the first dose of tovorafenib (DAY101) and from planned administration for the duration of study participation * Medications that are breast cancer resistant protein (BCRP) substrates that have a narrow therapeutic index are prohibited for 14 days before the first dose of tovorafenib (DAY101) and for the duration of study participation * Peripheral absolute neutrophil count (ANC) \>= 750/uL unless secondary to bone marrow involvement, in such cases bone marrow involvement must be documented (must be performed within 7 days prior to enrollment, must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment) * Platelet count \>= 75,000/uL (unsupported/without transfusion within the past 7 days) (must be performed within 7 days prior to enrollment, must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment) * Patients with marrow disease must have platelet count of \>= 75,000/uL (transfusion support allowed) and must not be refractory to platelet transfusions. Bone marrow involvement must be documented * Hemoglobin \>= 8 g/dL (unsupported/without transfusion within the past 7 days). Patients with marrow disease must have hemoglobin \>= 8 g/dL (transfusion support allowed). Bone marrow involvement must be documented * Hematopoietic growth factors: At least 14 days after the last dose of a long-acting growth factor (e.g., Neulasta \[registered trademark\]) or 7 days for short-acting growth factor * A serum creatinine based on age/sex as follows (must be performed within 7 days prior to enrollment, must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment) * Age: 6 months to \< 1 year; Maximum Serum Creatinine (mg/dL):= 0.5 mg/dl (male and female) * Age: 1 to \< 2 years; Maximum Serum Creatinine (mg/dL): = 0.6 mg/dl (male and female) * Age: 2 to \< 6 years; Maximum Serum Creatinine (mg/dL): = 0.8 mg/dl (male and female) * Age: 6 to \< 10 years; Maximum Serum Creatinine (mg/dL): = 1.0 mg/dl (male and female) * Age: 10 to \< 13 years; Maximum Serum Creatinine (mg/dL): = 1.2 mg/dl (male and female) * Age: 13 to \< 16 years; Maximum Serum Creatinine (mg/dL): = 1.5 mg/dl (male) and 1.4 mg/dl (female) * Age: \>= 16 years; Maximum Serum Creatinine (mg/dL): = 1.7 mg/dl (male) and 1.4 mg/dl (female) * OR- a 24 hour urine creatinine clearance \>= 50 mL/min/1.73 m\^2 * OR- a glomerular filtration rate (GFR) \>= 50 mL/min/1.73 m\^2. GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard) * Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility * Bilirubin (sum of conjugated + unconjugated) =\< 1.5 x upper limit of normal (ULN) for age (must be performed within 7 days prior to enrollment, must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment) * Alanine aminotransferase (ALT) =\< 3 x ULN for age (must be performed within 7 days prior to enrollment, must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment) * Serum albumin \>= 2 g/dl must be performed within 7 days prior to enrollment, must be repeated prior to the start of protocol therapy if \> 7 days have elapsed from their most recent prior assessment) * For patients with liver disease caused by their histiocytic disorder (as evaluated on radiographic imaging or biopsy): patients may be enrolled with abnormal bilirubin, aspartate aminotransferase (AST), ALT and albumin with documentation of histiocytic liver disease * Fractional shortening (FS) of \>= 25% or ejection fraction of \>= 50%, as determined by echocardiography or multigated acquisition scan (MUGA) within 28 days prior to study enrollment. Depending on institutional standard, either FS or left ventricular ejection fraction (LVEF) is adequate for enrollment if only one value is measured; if both values are measured, then both values must meet criteria above (must be obtained within 28 days prior to enrollment and start of protocol therapy) (repeat if necessary) * No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \> 94% if there is clinical indication for determination; unless it is due to underlying pulmonary LCH * Central Nervous System Function Defined As: * Patients with seizure disorder may be enrolled if well controlled * Central nervous system (CNS) toxicity =\< Grade 2 * Human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial unless antiretroviral therapy interacts with the metabolism of tovorafenib (DAY101) and cannot safely be changed to antivirals that do not interact with study medication * All patients and/or their parent(s) or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met.
Exclusion Criteria:
* LCH arising along with other hematologic malignancy (e.g. mixed LCH with acute lymphoblastic leukemia) or any history of non-histiocytic malignancy * Disease scenarios as below will be excluded * Skin-limited disease * Gastrointestinal (GI) tract involvement only (those that have disease that can be determined by endoscopic biopsies only) * LCH-associated neurodegeneration (LCH-ND) without parenchymal lesions or other systemic lesions * Patients with activating mutations in MAP2K1 are not eligible for this study due to drug target specificity. Mutation status will be submitted to study team within 7 days of enrollment * Refractory nausea and vomiting, malabsorption, or external biliary shunt that would preclude adequate absorption of tovorafenib (DAY101) * Uncontrolled systemic bacterial, viral, or fungal infection * Major surgical procedure or significant traumatic injury within 14 days prior to study enrollment, or anticipation of need for major surgical procedure during the course of the study. Placement of a vascular access device or minor surgery is permitted within fourteen (14) days of study enrollment (provided that the wound has healed) * History of significant bowel resection that would preclude adequate absorption or other significant malabsorptive disease * Ophthalmologic considerations: Patients with known significant ophthalmologic conditions or known risk factors for retinal vein occlusion (RVO) or central serous retinopathy (CSR) are not eligible * History of solid organ or hematopoietic bone marrow transplantation * Clinically significant active cardiovascular disease, or history of myocardial infarction, or deep vein thrombosis/pulmonary embolism within 6 months prior to enrollment, ongoing cardiomyopathy, or current prolonged QT interval \> 440 ms based on triplicate electrocardiogram (ECG) average * History of Grade \>= 2 CNS hemorrhage or history of any CNS hemorrhage within 28 days of study entry * History of any drug reaction with eosinophilia and systemic symptoms (DRESS) syndrome or Stevens Johnsons syndrome (SJS) or who are allergic to tovorafenib (DAY101) or any of its components * CTCAE version (V.) 5.0 Grade 3 symptomatic creatinine kinase (CPK) elevation (\> 5 x ULN) * Female patients who are pregnant are ineligible. A pregnancy test is required for female patients of childbearing potential * Lactating females who plan to breastfeed their infants are ineligible * Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation are ineligible. Women of childbearing potential must use non-hormonal contraception during tovorafenib treatment and for at least 28 days after the last dose. Men should use effective contraception and must not father a child while taking tovorafenib and for 14 days after the last dose
PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Computed Tomography, PROCEDURE: Echocardiography Test, PROCEDURE: FDG-Positron Emission Tomography and Computed Tomography Scan, PROCEDURE: Lumbar Puncture, PROCEDURE: Multigated Acquisition Scan, DRUG: Tovorafenib
Recurrent Langerhans Cell Histiocytosis, Refractory Langerhans Cell Histiocytosis
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Study Locations

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Albany Medical Center Albany, New York
Alfred I duPont Hospital for Children Wilmington, Delaware Site Public Contact - (Allison.bruce@nemours.org)
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Arkansas Children's Hospital Little Rock, Arkansas
Arnold Palmer Hospital for Children Orlando, Florida Site Public Contact - (Jennifer.spinelli@orlandohealth.com)
BI-LO Charities Children's Cancer Center Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas Site Public Contact - (burton@bcm.edu)
Blank Children's Hospital Des Moines, Iowa Site Public Contact - (samantha.mallory@unitypoint.org)
British Columbia Children's Hospital Vancouver, British Columbia
Bronson Methodist Hospital Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, Site Public Contact - (rechclinique@crchudequebec.ulaval.ca)
Cardinal Glennon Children's Medical Center St Louis, Missouri
Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec Site Public Contact - (yvan.samson@umontreal.ca)
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca)
Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia Site Public Contact - (Olivia.Floyd@choa.org)
Children's Hospital London, Ontario
Children's Hospital Colorado Aurora, Colorado Site Public Contact - (josh.b.gordon@nsmtp.kp.org)
Children's Hospital Los Angeles Los Angeles, California
Children's Hospital New Orleans New Orleans, Louisiana
Children's Hospital and Medical Center of Omaha Omaha, Nebraska
Children's Hospital of Alabama Birmingham, Alabama Site Public Contact - (oncologyresearch@peds.uab.edu)
Children's Hospital of Orange County Orange, California Site Public Contact - (oncresearch@choc.org)
Children's Hospital of Philadelphia Philadelphia, Pennsylvania Site Public Contact - (CancerTrials@email.chop.edu)
Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania Site Public Contact - (jean.tersak@chp.edu)
Children's Hospital of San Antonio San Antonio, Texas Site Public Contact - (bridget.medina@christushealth.org)
Children's Hospital of Wisconsin Milwaukee, Wisconsin Site Public Contact - (MACCCTO@mcw.edu)
Children's Hospital of the King's Daughters Norfolk, Virginia Site Public Contact - (CCBDCresearch@chkd.org)
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota Site Public Contact - (pauline.mitby@childrensmn.org)
Children's National Medical Center Washington D.C., District of Columbia Site Public Contact - (OncCRC_OnCall@childrensnational.org)
Connecticut Children's Medical Center Hartford, Connecticut
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Dayton Children's Hospital Dayton, Ohio
Dell Children's Medical Center of Central Texas Austin, Texas Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org)
Duke University Medical Center Durham, North Carolina
East Carolina University Greenville, North Carolina Site Public Contact - (eubankss@ecu.edu)
East Tennessee Childrens Hospital Knoxville, Tennessee
El Paso Children's Hospital El Paso, Texas Site Public Contact - (ranjan.bista@ttuhsc.edu)
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Golisano Children's Hospital of Southwest Florida Fort Myers, Florida Site Public Contact - (molly.arnstrom@leehealth.org)
Hackensack University Medical Center Hackensack, New Jersey
Hospital for Sick Children Toronto, Ontario Site Public Contact - (ask.CRS@sickkids.ca)
IWK Health Centre Halifax, Nova Scotia Site Public Contact - (Research@iwk.nshealth.ca)
Kaiser Permanente Downey Medical Center Downey, California
Kaiser Permanente-Oakland Oakland, California Site Public Contact - (Kpoct@kp.org)
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York Site Public Contact - (CancerTrials@nyulangone.org)
Loma Linda University Medical Center Loma Linda, California
Lucile Packard Children's Hospital Stanford University Palo Alto, California Site Public Contact - (ccto-office@stanford.edu)
Lurie Children's Hospital-Chicago Chicago, Illinois
M D Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
Maimonides Medical Center Brooklyn, New York
McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario
Memorial Health University Medical Center Savannah, Georgia Site Public Contact - (Lorraine.OHara@hcahealthcare.com)
Memorial Sloan Kettering Cancer Center New York, New York
Mercy Hospital Saint Louis St Louis, Missouri
Methodist Children's Hospital of South Texas San Antonio, Texas Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com)
Michigan State University East Lansing, Michigan
Mission Hospital Asheville, North Carolina Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com)
Montefiore Medical Center - Moses Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu)
NYP/Weill Cornell Medical Center New York, New York
Nationwide Children's Hospital Columbus, Ohio Site Public Contact - (Melinda.Triplet@nationwidechildrens.org)
Nemours Children's Clinic - Pensacola Pensacola, Florida Site Public Contact - (helpdesk@childrensoncologygroup.org)
Nemours Children's Clinic-Jacksonville Jacksonville, Florida Site Public Contact - (Allison.bruce@nemours.org)
Nemours Children's Hospital Orlando, Florida Site Public Contact - (Allison.bruce@nemours.org)
New York Medical College Valhalla, New York
Nicklaus Children's Hospital Miami, Florida
Ochsner Medical Center Jefferson New Orleans, Louisiana Site Public Contact - (Elisemarie.curry@ochsner.org)
Oregon Health and Science University Portland, Oregon Site Public Contact - (trials@ohsu.edu)
Perth Children's Hospital Perth, Western Australia Site Public Contact - (helpdesk@childrensoncologygroup.org)
Primary Children's Hospital Salt Lake City, Utah
Prisma Health Richland Hospital Columbia, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington Site Public Contact - (HopeBeginsHere@providence.org)
Queensland Children's Hospital South Brisbane, Queensland
Rainbow Babies and Childrens Hospital Cleveland, Ohio
Riley Hospital for Children Indianapolis, Indiana
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver, Colorado Site Public Contact - (PSGResearchSharedMailbox@HCAHealthcare.com)
Royal Children's Hospital Parkville, Victoria Site Public Contact - (Jordan.Hansford@rch.org.au)
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey
Saint Christopher's Hospital for Children Philadelphia, Pennsylvania
Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida Site Public Contact - (jennifer.manns@baycare.org)
Saint Joseph's Regional Medical Center Paterson, New Jersey Site Public Contact - (HallL@sjhmc.org)
Saint Jude Midwest Affiliate Peoria, Illinois
Scott and White Memorial Hospital Temple, Texas
Seattle Children's Hospital Seattle, Washington
Sinai Hospital of Baltimore Baltimore, Maryland
State University of New York Upstate Medical University Syracuse, New York
Summerlin Hospital Medical Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Sydney Children's Hospital Randwick, New South Wales
The Children's Hospital at TriStar Centennial Nashville, Tennessee
The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York
UCSF Benioff Children's Hospital Oakland Oakland, California Site Public Contact - (PedOncRschOAK@ucsf.edu)
UCSF Medical Center-Mission Bay San Francisco, California Site Public Contact - (cancertrials@ucsf.edu)
UF Health Cancer Institute - Gainesville Gainesville, Florida Site Public Contact - (cancer-center@ufl.edu)
UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas Site Public Contact - (canceranswerline@UTSouthwestern.edu)
University of Alberta Hospital Edmonton, Alberta Site Public Contact - (pedsoncologyresearch@ahs.ca)
University of Chicago Comprehensive Cancer Center Chicago, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa
University of Kentucky/Markey Cancer Center Lexington, Kentucky
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida
University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota
University of Mississippi Medical Center Jackson, Mississippi
University of Nebraska Medical Center Omaha, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Texas Health Science Center at San Antonio San Antonio, Texas Site Public Contact - (phoresearchoffice@uthscsa.edu)
University of Virginia Cancer Center Charlottesville, Virginia Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Valley Children's Hospital Madera, California Site Public Contact - (Research@valleychildrens.org)
Vanderbilt University/Ingram Cancer Center Nashville, Tennessee
Wake Forest University Health Sciences Winston-Salem, North Carolina
Washington University School of Medicine St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
West Virginia University Charleston Division Charleston, West Virginia
Yale University New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)

A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab

ctrrecruit@vcu.edu

NCT05675410
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Inclusion Criteria:
* Patients must be 5 to 60 years of age at the time of enrollment * Patients with newly diagnosed untreated histologically confirmed classic Hodgkin lymphoma (cHL) (nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified \[NOS\]) with stage I or II disease * Patients must have bidimensionally measurable disease (at least one lesion with longest diameter \>= 1.5 cm) * Patients must have a whole body or limited whole body PET scan performed within 42 days prior to enrollment. PET-CT is strongly preferred. PET-MRI allowed if intravenous contrast enhanced CT is also obtained * Pediatric patients (age 5-17 years) with known or suspected mediastinal disease must have an upright posteroanterior (PA) chest X-ray (CXR) for assessment of bulky mediastinal disease. * Note: Pediatric patients who have received both a CT chest and upright PA CXR may meet the definition of bulk through either modality. * Patients \>= 18 years must have a performance status corresponding to Zubrod scores of 0, 1 or 2 * Patients =\< 17 years of age must have a Lansky performance score of \>= 50 * Pediatric patients (age 5-17 years): A serum creatinine based on age/sex as follows (within 28 days prior to enrollment): * 2 to \< 6 years (age): 0.8 mg/dL (male), 0.8 mg/dL (female) * 6 to \< 10 years (age): 1 mg/dL (male), 1 mg/dL (female) * 10 to \< 13 years (age): 1.2 mg/dL (male), 1.2 mg/dL (female) * 13 to \< 16 years (age): 1.5 mg/dL (male), 1.4 mg/dL (female) * \>= 16 years (age): 1.7 mg/dL (male), 1.4 mg/dL (female) OR a 24 hour urine creatinine clearance \>= 50 mL/min/1.73 m\^2 (within 28 days prior to enrollment) OR a glomerular filtration rate (GFR) \>= 50 mL/min/1.73 m\^2 (within 28 days prior to enrollment). GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard) * Note: Estimated GFR (eGFR) from serum or plasma creatinine, cystatin C or other estimates are not acceptable for determining eligibility * For adult patients (age 18 years or older) (within 28 days prior to enrollment): Creatinine clearance \>= 30 mL/min, as estimated by the Cockcroft and Gault formula or a 24-hour urine collection. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight * Total bilirubin =\< 2 x upper limit of normal (ULN) (within 28 days prior to enrollment) * Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome * Aspartate aminotransferase (AST) =\< 3 x ULN (within 28 days prior to enrollment) * Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome * Alanine aminotransferase (ALT) =\< 3 x ULN (within 28 days prior to enrollment) * Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome * Shortening fraction of \>= 27% by echocardiogram (ECHO), multigated acquisition scan (MUGA), or functional cardiac imaging scan (within 28 days prior to enrollment) or ejection fraction of \>= 50% by radionuclide angiogram, ECHO, MUGA, or cardiac imaging scan (within 28 days prior to enrollment) * Diffusion capacity of the lung for carbon monoxide (DLCO) \>= 50% of predicted value as corrected for hemoglobin by pulmonary function test (PFT) (within 28 days prior to enrollment). If unable to obtain PFTs, the criterion is: a pulse oximetry reading of \> 92% on room air * Known human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Exclusion Criteria:
* Patients with nodular lymphocyte predominant Hodgkin lymphoma * Patients with a history of active interstitial pneumonitis or interstitial lung disease * Patients with a diagnosis of inherited or acquired immunodeficiency that is poorly controlled or requiring active medications, such as primary immunodeficiency syndromes or organ transplant recipients * Patients with any known uncontrolled intercurrent illness that would jeopardize the patient's safety such as infection, autoimmune conditions, cardiac arrhythmias, angina pectoris, and gastrointestinal disorders affecting swallowing and/or absorption of pills * Patients with a condition requiring systemic treatment with either corticosteroids (defined as equivalent to \> 10 mg daily predniSONE for patients \>= 18 years or \> 0.5 mg/kg \[up to 10 mg/day\] for patients \< 18 years) or other immunosuppressive medications within 14 days prior to enrollment * Note: Replacement therapy such as thyroxine, insulin, or physiologic corticosteroid for adrenal or pituitary insufficiency is not considered a form of systemic treatment. Inhaled or topical steroids, and adrenal replacement doses (=\< 10 mg daily for patients \>= 18 years or =\< 0.5 mg/kg \[up to 10 mg/day\] predniSONE equivalents) are permitted in the absence of active autoimmune disease * Note: Steroid use for the control of Hodgkin lymphoma symptoms is allowable, but must be discontinued by cycle 1, day 1 * Short term use of corticosteroids for premedication or treatment of an allergy or hypersensitivity is considered an acceptable use of corticosteroids. * Patients with peripheral neuropathy \> grade 1 at the time of enrollment or patients with known Charcot-Marie-Tooth syndrome * Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen * Administration of prior chemotherapy, radiation, or antibody-based treatment for cHL * Prior solid organ transplant * Prior allogeneic stem cell transplantation * Live vaccine within 30 days prior to planned day 1 of protocol therapy (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, bacillus Calmette Guerin \[BCG\], oral polio vaccine, and oral typhoid). Administration of messenger ribonucleic acid (mRNA) vaccines are permitted * Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test within 28 days prior to enrollment is required for female patients of childbearing potential * Lactating females who plan to breastfeed their infants starting with the first dose of study therapy and for at least 6 months after the last treatment * Sexually active patients of reproductive potential who have not agreed to use a highly effective contraceptive method for the duration of their study drug therapy. Following therapy, patients will be advised to use contraception as per institutional practice or as listed below for investigational agents, whichever is longer * Men and women of childbearing potential (WOCBP) must use effective contraception during the study and for 2 months for WOCBP and 4 months for men, after last dose of brentuximab vedotin * WOCBP must continue contraception for a period of at least 5 months after the last dose of nivolumab * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
PROCEDURE: Biospecimen Collection, BIOLOGICAL: Bleomycin Sulfate, DRUG: Brentuximab Vedotin, PROCEDURE: Computed Tomography, DRUG: Cyclophosphamide, DRUG: Dacarbazine, DRUG: Doxorubicin Hydrochloride, DRUG: Etoposide, DRUG: Etoposide Phosphate, OTHER: Fludeoxyglucose F-18, RADIATION: Involved-site Radiation Therapy, PROCEDURE: Magnetic Resonance Imaging, BIOLOGICAL: Nivolumab, PROCEDURE: Positron Emission Tomography, DRUG: Prednisolone, DRUG: Prednisone, DRUG: Procarbazine Hydrochloride, OTHER: Questionnaire Administration, DRUG: Vinblastine Sulfate, DRUG: Vincristine Sulfate
Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8
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Study Locations

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AMG Crystal Lake - Oncology Crystal Lake, Illinois Site Public Contact - (advocateresearch@advocate.com)
AMG Libertyville - Oncology Libertyville, Illinois Site Public Contact - (advocateresearch@advocatehealth.com)
Abbott-Northwestern Hospital Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
AdventHealth Orlando Orlando, Florida Site Public Contact - (FH.Cancer.Research@flhosp.org)
Advocate Children's Hospital-Oak Lawn Oak Lawn, Illinois
Advocate Children's Hospital-Park Ridge Park Ridge, Illinois Site Public Contact - (helpdesk@childrensoncologygroup.org)
Advocate Christ Medical Center Oak Lawn, Illinois
Advocate Good Samaritan Hospital Downers Grove, Illinois Site Public Contact - (Barbara.barhamand@advocatehealth.com)
Advocate Good Shepherd Hospital Barrington, Illinois
Advocate Illinois Masonic Medical Center Chicago, Illinois
Advocate Lutheran General Hospital Park Ridge, Illinois
Advocate Sherman Hospital Elgin, Illinois
Advocate South Suburban Hospital Hazel Crest, Illinois
Albany Medical Center Albany, New York
Alberta Children's Hospital Calgary, Alberta Site Public Contact - (research4kids@ucalgary.ca)
Alfred I duPont Hospital for Children Wilmington, Delaware Site Public Contact - (Allison.bruce@nemours.org)
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Arkansas Children's Hospital Little Rock, Arkansas
Arnold Palmer Hospital for Children Orlando, Florida Site Public Contact - (Jennifer.spinelli@orlandohealth.com)
Ascension Saint Vincent Indianapolis Hospital Indianapolis, Indiana Site Public Contact - (research@stvincent.org)
Atrium Health Navicent Macon, Georgia Site Public Contact - (andrew.weatherall@atriumhealth.org)
Augusta University Medical Center Augusta, Georgia Site Public Contact - (ga_cares@augusta.edu)
Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora BayCare Medical Center Green Bay, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Grafton Grafton, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Kenosha South Kenosha, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Racine Racine, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Health Care Germantown Health Center Germantown, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Medical Center in Summit Summit, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Saint Luke's Medical Center Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Saint Luke's South Shore Cudahy, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Sinai Medical Center Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora West Allis Medical Center West Allis, Wisconsin Site Public Contact - (ncorp@aurora.org)
BI-LO Charities Children's Cancer Center Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas Site Public Contact - (burton@bcm.edu)
Beacon Kalamazoo Cancer Center Kalamazoo, Michigan
Blank Children's Hospital Des Moines, Iowa Site Public Contact - (samantha.mallory@unitypoint.org)
Bronson Battle Creek Battle Creek, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Bronson Methodist Hospital Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Broward Health Medical Center Fort Lauderdale, Florida Site Public Contact - (Allison.bruce@nemours.org)
C S Mott Children's Hospital Ann Arbor, Michigan
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, Site Public Contact - (rechclinique@crchudequebec.ulaval.ca)
CTCA at Western Regional Medical Center Goodyear, Arizona
Cancer Care and Hematology-Fort Collins Fort Collins, Colorado Site Public Contact - (ctsucontact@westat.com)
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan Site Public Contact - (connie.szczepanek@crcwm.org)
CancerCare Manitoba Winnipeg, Manitoba Site Public Contact - (ctu_web@cancercare.mb.ca)
Cardinal Glennon Children's Medical Center St Louis, Missouri
Carilion Children's Roanoke, Virginia Site Public Contact - (wpmccarty@carilionclinic.org)
Carle Cancer Center Urbana, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Effingham Effingham, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Mattoon/Charleston Mattoon, Illinois Site Public Contact - (Research@carle.com)
Carle at The Riverfront Danville, Illinois Site Public Contact - (Research@Carle.com)
Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina
Cedars Sinai Medical Center Los Angeles, California
Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec Site Public Contact - (yvan.samson@umontreal.ca)
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca)
Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia Site Public Contact - (Olivia.Floyd@choa.org)
Children's Hospital London, Ontario
Children's Hospital Colorado Aurora, Colorado Site Public Contact - (josh.b.gordon@nsmtp.kp.org)
Children's Hospital Los Angeles Los Angeles, California
Children's Hospital Medical Center Of Akron Akron, Ohio
Children's Hospital New Orleans New Orleans, Louisiana
Children's Hospital Of Eastern Ontario Ottawa, Ontario
Children's Hospital and Medical Center of Omaha Omaha, Nebraska
Children's Hospital of Alabama Birmingham, Alabama Site Public Contact - (oncologyresearch@peds.uab.edu)
Children's Hospital of Michigan Detroit, Michigan Site Public Contact - (helpdesk@childrensoncologygroup.org)
Children's Hospital of Orange County Orange, California Site Public Contact - (oncresearch@choc.org)
Children's Hospital of Philadelphia Philadelphia, Pennsylvania Site Public Contact - (CancerTrials@email.chop.edu)
Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania Site Public Contact - (jean.tersak@chp.edu)
Children's Hospital of San Antonio San Antonio, Texas Site Public Contact - (bridget.medina@christushealth.org)
Children's Hospital of Wisconsin Milwaukee, Wisconsin Site Public Contact - (MACCCTO@mcw.edu)
Children's Hospital of the King's Daughters Norfolk, Virginia Site Public Contact - (CCBDCresearch@chkd.org)
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota Site Public Contact - (pauline.mitby@childrensmn.org)
Children's Mercy Hospitals and Clinics Kansas City, Missouri Site Public Contact - (COGResearchGroup@cmh.edu)
Children's National Medical Center Washington D.C., District of Columbia Site Public Contact - (OncCRC_OnCall@childrensnational.org)
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio Site Public Contact - (cancer@cchmc.org)
City of Hope Antelope Valley Lancaster, California Site Public Contact - (becomingapatient@coh.org)
City of Hope Comprehensive Cancer Center Duarte, California Site Public Contact - (becomingapatient@coh.org)
City of Hope Corona Corona, California Site Public Contact - (becomingapatient@coh.org)
City of Hope Newport Beach Newport Beach, California
City of Hope Seacliff Huntington Beach, California
City of Hope South Bay Torrance, California
City of Hope South Pasadena South Pasadena, California Site Public Contact - (becomingapatient@coh.org)
City of Hope Upland Upland, California Site Public Contact - (becomingapatient@coh.org)
City of Hope at Irvine Lennar Irvine, California
City of Hope at Long Beach Elm Long Beach, California
Cleveland Clinic Foundation Cleveland, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Community Medical Center Missoula, Montana Site Public Contact - (Lennette.Gonzales@rwjbh.org)
Condell Memorial Hospital Libertyville, Illinois Site Public Contact - (advocateresearch@advocatehealth.com)
Connecticut Children's Medical Center Hartford, Connecticut
Cook Children's Medical Center Fort Worth, Texas Site Public Contact - (CookChildrensResearch@cookchildrens.org)
Cooper Hospital University Medical Center Camden, New Jersey
Corewell Health Beaumont Troy Hospital Troy, Michigan
Corewell Health Children's Royal Oak, Michigan
Corewell Health Dearborn Hospital Dearborn, Michigan
Corewell Health Farmington Hills Hospital Farmington Hills, Michigan
Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Reed City Hospital Reed City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health William Beaumont University Hospital Royal Oak, Michigan
Covenant Children's Hospital Lubbock, Texas Site Public Contact - (mbisbee@providence.org)
Crossroads Cancer Center Effingham, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Dana-Farber Cancer Institute Boston, Massachusetts
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center Lebanon, New Hampshire Site Public Contact - (cancer.research.nurse@dartmouth.edu)
Dayton Children's Hospital Dayton, Ohio
Decatur Memorial Hospital Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Dell Children's Medical Center of Central Texas Austin, Texas Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org)
Driscoll Children's Hospital Corpus Christi, Texas Site Public Contact - (Crystal.DeLosSantos@dchstx.org)
Duke University Medical Center Durham, North Carolina
East Carolina University Greenville, North Carolina Site Public Contact - (eubankss@ecu.edu)
East Tennessee Childrens Hospital Knoxville, Tennessee
Eastern Maine Medical Center Bangor, Maine
Edward Hospital/Cancer Center Naperville, Illinois
Edward Hospital/Cancer Center?Plainfield Plainfield, Illinois Site Public Contact - (Cancerresearch@edward.org)
Edwards Comprehensive Cancer Center Huntington, West Virginia Site Public Contact - (Christina.Cole@chhi.org)
El Paso Children's Hospital El Paso, Texas Site Public Contact - (ranjan.bista@ttuhsc.edu)
Elmhurst Memorial Hospital Elmhurst, Illinois Site Public Contact - (Jrohde@emhc.org)
Emory Proton Therapy Center Atlanta, Georgia Site Public Contact - (allyson.anderson@emory.edu)
Emory Saint Joseph's Hospital Atlanta, Georgia
Emory University Hospital Midtown Atlanta, Georgia
Emory University Hospital/Winship Cancer Institute Atlanta, Georgia
Fairview Southdale Hospital Edina, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Glens Falls Hospital Glens Falls, New York
Golisano Children's Hospital of Southwest Florida Fort Myers, Florida Site Public Contact - (molly.arnstrom@leehealth.org)
Grady Health System Atlanta, Georgia
Gundersen Lutheran Medical Center La Crosse, Wisconsin Site Public Contact - (cancerctr@gundersenhealth.org)
HSHS Saint Elizabeth's Hospital O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Hackensack University Medical Center Hackensack, New Jersey
Hematology Oncology Associates of CNY at Camillus Camillus, New York
Hematology Oncology Associates of Central New York-East Syracuse East Syracuse, New York
Henry Ford Hospital Detroit, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford Macomb Hospital-Clinton Township Clinton Township, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford Medical Center-Columbus Novi, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Henry Ford West Bloomfield Hospital West Bloomfield, Michigan Site Public Contact - (CTOResearch@hfhs.org)
Hospital for Sick Children Toronto, Ontario Site Public Contact - (ask.CRS@sickkids.ca)
Hunterdon Medical Center Flemington, New Jersey
Huntsman Cancer Institute/University of Utah Salt Lake City, Utah Site Public Contact - (cancerinfo@hci.utah.edu)
IWK Health Centre Halifax, Nova Scotia Site Public Contact - (Research@iwk.nshealth.ca)
Inova Fairfax Hospital Falls Church, Virginia Site Public Contact - (Stephanie.VanBebber@inova.org)
Iowa Methodist Medical Center Des Moines, Iowa
Jersey City Medical Center Jersey City, New Jersey Site Public Contact - (ctsucontact@westat.com)
Jersey Shore Medical Center Neptune City, New Jersey
Jim Pattison Children's Hospital Saskatoon, Saskatchewan Site Public Contact - (Jessica.Marien@saskhealthauthority.ca)
Johns Hopkins All Children's Hospital St. Petersburg, Florida Site Public Contact - (Ashley.Repp@jhmi.edu)
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Kaiser Permanente Downey Medical Center Downey, California
Kaiser Permanente Downtown Commons Sacramento, California Site Public Contact - (kpoct@kp.org)
Kaiser Permanente Dublin Dublin, California
Kaiser Permanente Fresno Orchard Plaza Fresno, California
Kaiser Permanente San Leandro San Leandro, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Fremont Fremont, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Fresno Fresno, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Modesto Modesto, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Oakland Oakland, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-San Francisco San Francisco, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Santa Rosa Santa Rosa, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Santa Teresa-San Jose San Jose, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-South Sacramento Sacramento, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-South San Francisco South San Francisco, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Vallejo Vallejo, California Site Public Contact - (Kpoct@kp.org)
Kaiser Permanente-Walnut Creek Walnut Creek, California Site Public Contact - (Kpoct@kp.org)
Kaiser San Rafael-Gallinas San Rafael, California Site Public Contact - (Kpoct@kp.org)
Kapiolani Medical Center for Women and Children Honolulu, Hawaii
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York Site Public Contact - (CancerTrials@nyulangone.org)
Legacy Emanuel Children's Hospital Portland, Oregon
Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Loma Linda University Medical Center Loma Linda, California
Loyola University Medical Center Maywood, Illinois
Lurie Children's Hospital-Chicago Chicago, Illinois
M D Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
Maine Children's Cancer Program Scarborough, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
MaineHealth Cancer Care Center of York County Sanford, Maine
MaineHealth Cancer Care and IV Therapy - South Portland South Portland, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
MaineHealth Coastal Cancer Treatment Center Bath, Maine Site Public Contact - (ctsucontact@westat.com)
MaineHealth Maine Medical Center - Portland Portland, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
MaineHealth Maine Medical Center- Scarborough Scarborough, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Mary Bridge Children's Hospital and Health Center Tacoma, Washington Site Public Contact - (research@multicare.org)
Mayo Clinic in Rochester Rochester, Minnesota
McMaster Children's Hospital at Hamilton Health Sciences Hamilton, Ontario
MedStar Georgetown University Hospital Washington D.C., District of Columbia
Medical Center of the Rockies Loveland, Colorado
Medical City Dallas Hospital Dallas, Texas
Medical University of South Carolina Charleston, South Carolina Site Public Contact - (hcc-clinical-trials@musc.edu)
Memorial Health University Medical Center Savannah, Georgia Site Public Contact - (Lorraine.OHara@hcahealthcare.com)
Memorial Hospital East Shiloh, Illinois Site Public Contact - (dschwab@wustl.edu)
Memorial Hospital North Colorado Springs, Colorado
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida Site Public Contact - (OHR@mhs.net)
Memorial Sloan Kettering Cancer Center New York, New York
Mercy Cancer Center - Carmichael Carmichael, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Cancer Center - Elk Grove Elk Grove, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Cancer Center - Rocklin Rocklin, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Cancer Center - Sacramento Sacramento, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Hospital Cedar Rapids, Iowa Site Public Contact - (mmcorc@healthpartners.com)
Mercy Hospital Saint Louis St Louis, Missouri
Mercy San Juan Medical Center Carmichael, California Site Public Contact - (OncologyResearch@DignityHealth.org)
Methodist Children's Hospital of South Texas San Antonio, Texas Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com)
Michigan State University East Lansing, Michigan
Miller Children's and Women's Hospital Long Beach Long Beach, California
Minnesota Oncology Hematology PA-Woodbury Woodbury, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Mission Hospital Asheville, North Carolina Site Public Contact - (NCDV.ResearchRegulatory@HCAHealthcare.com)
Monmouth Medical Center Long Branch, New Jersey Site Public Contact - (mary.danish@rwjbh.org)
Montefiore Medical Center - Moses Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Morristown Medical Center Morristown, New Jersey
Mount Sinai Hospital New York, New York Site Public Contact - (CCTO@mssm.edu)
Mount Sinai Hospital Medical Center Chicago, Illinois Site Public Contact - (suhi@sinai.org)
Munson Medical Center Traverse City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center New York, New York Site Public Contact - (cancerclinicaltrials@cumc.columbia.edu)
NYP/Weill Cornell Medical Center New York, New York
NYU Langone Hospital - Long Island Mineola, New York Site Public Contact - (cancertrials@nyulangone.org)
Natalie Warren Bryant Cancer Center at Saint Francis Tulsa, Oklahoma
Nationwide Children's Hospital Columbus, Ohio Site Public Contact - (Melinda.Triplet@nationwidechildrens.org)
Naval Medical Center - Portsmouth Portsmouth, Virginia
Naval Medical Center -San Diego San Diego, California
Nebraska Medicine-Bellevue Bellevue, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
Nebraska Medicine-Village Pointe Omaha, Nebraska
Nemours Children's Clinic - Pensacola Pensacola, Florida Site Public Contact - (helpdesk@childrensoncologygroup.org)
Nemours Children's Clinic-Jacksonville Jacksonville, Florida Site Public Contact - (Allison.bruce@nemours.org)
Nemours Children's Hospital Orlando, Florida Site Public Contact - (Allison.bruce@nemours.org)
Newark Beth Israel Medical Center Newark, New Jersey Site Public Contact - (Christine.Kosmides@rwjbh.org)
Nicklaus Children's Hospital Miami, Florida
NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois
NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois
NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois
Northwestern Medicine Cancer Center Delnor Geneva, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Glenview Outpatient Center Glenview, Illinois
Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois
Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois
Northwestern Medicine Orland Park Orland Park, Illinois Site Public Contact - (nctnprogram_rhlccc@northwestern.edu)
Northwestern University Chicago, Illinois Site Public Contact - (cancer@northwestern.edu)
Norton Children's Hospital Louisville, Kentucky Site Public Contact - (CancerResource@nortonhealthcare.org)
Ochsner Medical Center Jefferson New Orleans, Louisiana Site Public Contact - (Elisemarie.curry@ochsner.org)
Oregon Health and Science University Portland, Oregon Site Public Contact - (trials@ohsu.edu)
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Penn State Children's Hospital Hershey, Pennsylvania
Phoenix Childrens Hospital Phoenix, Arizona
Poudre Valley Hospital Fort Collins, Colorado
Presbyterian Hospital Albuquerque, New Mexico Site Public Contact - (wburman@phs.org)
Primary Children's Hospital Salt Lake City, Utah
Prisma Health Cancer Institute - Eastside Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Spartanburg Boiling Springs, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Richland Hospital Columbia, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
ProHealth D N Greenwald Center Mukwonago, Wisconsin Site Public Contact - (research.institute@phci.org)
ProHealth Oconomowoc Memorial Hospital Oconomowoc, Wisconsin
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio Site Public Contact - (PCIOncResearch@promedica.org)
Providence Alaska Medical Center Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Providence Newberg Medical Center Newberg, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Portland Medical Center Portland, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington Site Public Contact - (HopeBeginsHere@providence.org)
Providence Saint Vincent Medical Center Portland, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Providence Willamette Falls Medical Center Oregon City, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Rady Children's Hospital - San Diego San Diego, California
Rainbow Babies and Childrens Hospital Cleveland, Ohio
Regions Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Renown Regional Medical Center Reno, Nevada Site Public Contact - (research@sncrf.org)
Rhode Island Hospital Providence, Rhode Island
Riley Hospital for Children Indianapolis, Indiana
Roswell Park Cancer Institute Buffalo, New York Site Public Contact - (askroswell@roswellpark.org)
Rush-Copley Healthcare Center Yorkville, Illinois Site Public Contact - (Cancer.Research@rushcopley.com)
Rush-Copley Medical Center Aurora, Illinois Site Public Contact - (RCMC_Cancer_Research@rush.edu)
Rutgers Cancer Institute of New Jersey New Brunswick, New Jersey
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey
Sacred Heart Hospital Pensacola, Florida
Saint Alphonsus Cancer Care Center-Nampa Nampa, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Saint Barnabas Medical Center Livingston, New Jersey
Saint Christopher's Hospital for Children Philadelphia, Pennsylvania
Saint Francis Cancer Center Greenville, South Carolina Site Public Contact - (Heather_Rich@bshsi.org)
Saint Francis Hospital Federal Way, Washington Site Public Contact - (Heather_Rich@bshsi.org)
Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida Site Public Contact - (jennifer.manns@baycare.org)
Saint Joseph's Regional Medical Center Paterson, New Jersey Site Public Contact - (HallL@sjhmc.org)
Saint Jude Midwest Affiliate Peoria, Illinois
Saint Luke's Cancer Institute - Boise Boise, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Fruitland Fruitland, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Meridian Meridian, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Nampa Nampa, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Cancer Institute - Twin Falls Twin Falls, Idaho Site Public Contact - (eslinget@slhs.org)
Saint Luke's Hospital Chesterfield, Missouri
Saint Mary's Medical Center West Palm Beach, Florida
Saint Peter's University Hospital New Brunswick, New Jersey Site Public Contact - (kcovert@saintpetersuh.com)
Saint Vincent Hospital Cancer Center Green Bay Green Bay, Wisconsin Site Public Contact - (WI_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Sheboygan Sheboygan, Wisconsin Site Public Contact - (wi_research_admin@hshs.org)
Saint Vincent Hospital Cancer Center at Sturgeon Bay Sturgeon Bay, Wisconsin Site Public Contact - (wi_research_admin@hshs.org)
Sanford Broadway Medical Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org)
Santa Barbara Cottage Hospital Santa Barbara, California
Scott and White Memorial Hospital Temple, Texas
Seattle Children's Hospital Seattle, Washington
Sinai Hospital of Baltimore Baltimore, Maryland
Siteman Cancer Center at Christian Hospital St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
Siteman Cancer Center at Saint Peters Hospital City of Saint Peters, Missouri Site Public Contact - (info@siteman.wustl.edu)
Siteman Cancer Center at West County Hospital Creve Coeur, Missouri Site Public Contact - (info@siteman.wustl.edu)
Siteman Cancer Center-South County St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
Smilow Cancer Hospital Care Center - Guilford Guilford, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center - Waterford Waterford, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center - Westerly Westerly, Rhode Island Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center at Glastonbury Glastonbury, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center at Greenwich Greenwich, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center at Long Ridge Stamford, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center at Saint Francis Hartford, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center-Fairfield Fairfield, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital Care Center-Trumbull Trumbull, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital-Derby Care Center Derby, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital-Torrington Care Center Torrington, Connecticut Site Public Contact - (canceranswers@yale.edu)
Smilow Cancer Hospital-Waterbury Care Center Waterbury, Connecticut Site Public Contact - (canceranswers@yale.edu)
Southern Illinois University School of Medicine Springfield, Illinois
State University of New York Upstate Medical University Syracuse, New York
Stony Brook University Medical Center Stony Brook, New York
Swedish Covenant Hospital Chicago, Illinois
T C Thompson Children's Hospital Chattanooga, Tennessee
Tampa General Hospital Tampa, Florida Site Public Contact - (syapchanyk@tgh.org)
The Children's Hospital at TriStar Centennial Nashville, Tennessee
The James Graham Brown Cancer Center at University of Louisville Louisville, Kentucky
The Montreal Children's Hospital of the MUHC Montreal, Quebec Site Public Contact - (info@thechildren.com)
The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York
Trinitas Hospital and Comprehensive Cancer Center - Williamson Street Campus Elizabeth, New Jersey
Trinity Health Grand Rapids Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology - Canton Canton, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Muskegon Hospital Muskegon, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Trinity Health Saint Joseph Mercy Hospital Ann Arbor Ann Arbor, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Saint Joseph Mercy Oakland Hospital Pontiac, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Trinity Health Saint Mary Mercy Livonia Hospital Livonia, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange, California Site Public Contact - (ucstudy@uci.edu)
UCHealth Greeley Hospital Greeley, Colorado Site Public Contact - (ctsucontact@westat.com)
UCHealth Memorial Hospital Central Colorado Springs, Colorado
UCHealth University of Colorado Hospital Aurora, Colorado
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine, California Site Public Contact - (ucstudy@uci.edu)
UF Health Cancer Institute - Gainesville Gainesville, Florida Site Public Contact - (cancer-center@ufl.edu)
UI Health Care Mission Cancer and Blood - Ankeny Clinic Ankeny, Iowa
UI Health Care Mission Cancer and Blood - Des Moines Clinic Des Moines, Iowa
UI Health Care Mission Cancer and Blood - Laurel Clinic Des Moines, Iowa
UI Health Care Mission Cancer and Blood - Waukee Clinic Waukee, Iowa
UI Health Care Mission Cancer and Blood - West Des Moines Clinic Clive, Iowa
UMC Cancer Center / UMC Health System Lubbock, Texas
UMass Memorial Medical Center - University Campus Worcester, Massachusetts Site Public Contact - (cancer.research@umassmed.edu)
UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina Site Public Contact - (cancerclinicaltrials@med.unc.edu)
USA Health Strada Patient Care Center Mobile, Alabama
UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas Site Public Contact - (canceranswerline@UTSouthwestern.edu)
UW Cancer Center at ProHealth Care Waukesha, Wisconsin Site Public Contact - (Chanda.miller@phci.org)
UW Health Carbone Cancer Center Rockford Rockford, Illinois Site Public Contact - (lkline@uwhealth.org)
United Hospital Saint Paul, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
University Pediatric Hospital San Juan,
University of Alberta Hospital Edmonton, Alberta Site Public Contact - (pedsoncologyresearch@ahs.ca)
University of Chicago Comprehensive Cancer Center Chicago, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
University of Illinois Chicago, Illinois
University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa
University of Kentucky/Markey Cancer Center Lexington, Kentucky
University of Maryland/Greenebaum Cancer Center Baltimore, Maryland
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida
University of Michigan Health - West Wyoming, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
University of Minnesota/Masonic Cancer Center Minneapolis, Minnesota
University of Mississippi Medical Center Jackson, Mississippi
University of Nebraska Medical Center Omaha, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
University of New Mexico Cancer Center Albuquerque, New Mexico Site Public Contact - (HSC-ClinicalTrialInfo@salud.unm.edu)
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Rochester Rochester, New York
University of Texas Health Science Center at San Antonio San Antonio, Texas Site Public Contact - (phoresearchoffice@uthscsa.edu)
University of Vermont and State Agricultural College Burlington, Vermont Site Public Contact - (rpo@uvm.edu)
University of Virginia Cancer Center Charlottesville, Virginia Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu)
University of Wisconsin Carbone Cancer Center - Eastpark Medical Center Madison, Wisconsin Site Public Contact - (clinicaltrials@cancer.wisc.edu)
University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin Site Public Contact - (clinicaltrials@cancer.wisc.edu)
UofL Health Medical Center Northeast Louisville, Kentucky Site Public Contact - (ctoinfo@louisville.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Valley Medical Center Renton, Washington Site Public Contact - (research@valleymed.org)
Vanderbilt University/Ingram Cancer Center Nashville, Tennessee
Vince Lombardi Cancer Clinic - Oshkosh Oshkosh, Wisconsin Site Public Contact - (ncorp@aurora.org)
Vince Lombardi Cancer Clinic-Sheboygan Sheboygan, Wisconsin Site Public Contact - (ncorp@aurora.org)
Vince Lombardi Cancer Clinic-Two Rivers Two Rivers, Wisconsin Site Public Contact - (ncorp@aurora.org)
Wake Forest University Health Sciences Winston-Salem, North Carolina
Walter Reed National Military Medical Center Bethesda, Maryland
Washington University School of Medicine St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
Wayne State University/Karmanos Cancer Institute Detroit, Michigan Site Public Contact - (ctoadmin@karmanos.org)
Weisberg Cancer Treatment Center Farmington Hills, Michigan Site Public Contact - (ctoadmin@karmanos.org)
Wesley Medical Center Wichita, Kansas Site Public Contact - (WesleyResearch@wesleymc.com)
West Michigan Cancer Center Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
West Virginia University Charleston Division Charleston, West Virginia
Wilmot Cancer Institute at Webster Webster, New York Site Public Contact - (WCICTOresearch@urmc.rochester.edu)
Woodland Memorial Hospital Woodland, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Yale University New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)
Yale-New Haven Hospital North Haven Medical Center North Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)

Trial Readiness and Endpoint Assessment in Pediatric Myotonic Dystrophy Extension (TREAT-EXT)

Ruby Langeslay, MPH - Ruby.Langeslay@vcuhealth.org

NCT06747884
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Inclusion Criteria (Congenital Myotonic Dystrophy Group): * Age 5-17 years, 11 months at enrollment. Lower age limit not applicable for participants who have completed ASPIRE-DM1 protocol. Upper age limit not applicable for participants who previously participated in TREAT-01-001 (TREAT-CDM) study * A diagnosis of CDM, defined as: children having symptoms of myotonic dystrophy in the newborn period (\<30 days), such as hypotonia, feeding or respiratory difficulty, requiring hospitalization to a ward or to the neonatal intensive care unit for more than 72 hours; and a genetic test confirming an expanded trinucleotide (CTG) repeat in the DMPK gene in the child or mother. An expanded CTG repeat size in the child is considered greater than 200 repeats or E1-E4 classification (E1= 200-500, E2=500-1,000, E3=1,000-1,500, E4\>1,500). * Written, voluntary informed consent must be obtained before any study related procedures are conducted. Inclusion Criteria (Childhood Myotonic Dystrophy Group): * Age 3-17 years, 11 months at enrollment. Upper age limit not applicable for participants who previously participated in TREAT-01-001 (TREAT-CDM) study. * A diagnosis of ChDM, defined as: children having cognitive deficits, muscle weakness, myotonia that developed after age 1 and prior to age 10 and a genetic test confirming an expanded trinucleotide (CTG) repeat in the DMPK gene in the child or mother. An expanded CTG repeat size in the child is considered greater than 200 repeats or E1-E4 classification (E1= 200-500, E2=500-1,000, E3=1,000-1,500, E4\>1,500). * Written, voluntary informed consent must be obtained before any study related procedures are conducted.
Exclusion Criteria:
* Any other non-DM1 illness that would interfere with the ability to undergo safe testing or would affect the interpretation of the results, in the opinion of the site investigator * Significant trauma within the past month * Internal metal or devices (exclusion for DEXA component) * Use of anticoagulants, such as warfarin or a direct oral anticoagulant (e.g., dabigatran) due to the increased risk of bleeding with biopsy * Platelet count \<50,000 * History of a bleeding disorder * Participation in a clinical trial involving an investigational product * History of adverse reaction to lidocaine (if participating in muscle biopsy)
Congenital Myotonic Dystrophy, Childhood Myotonic Dystrophy, Myotonic Dystrophy
DM1, Childhood Myotonic Dystrophy, Congenital Myotonic Dystrophy, Myotonic Dystrophy, Myotonia, Dystrophy Myotonic, DMCRN, TREAT-EXT, TREAT CDM
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Virginia Commonwealth University Richmond, Virginia Shantel Kyles - (shantel.brown@vcuhealth.org) Levi Headrick - (levi.headrick@vcuhealth.org)

AFFINITY DUCHENNE: RGX-202 Gene Therapy in Participants With Duchenne Muscular Dystrophy (DMD)

Patient Advocacy - Duchenne@regenxbio.com

NCT05693142
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Part 1 - Key
Inclusion Criteria:
* The participant's legal guardian(s) is (are) willing and able to provide written, signed informed consent prior to any study-related procedures; and, where applicable, the minor participant has provided written or verbal assent according to local requirements. * Is a male at least 4 years of age and less than 12 years of age at consent or 1 to \<4 years of age at the time of dosing and ≥ 10 kg at the time of screening. * Must meet any of the following criteria: * DMD gene mutation in exons 18 and above, and a clinical picture consistent with typical DMD with the exception of a participant (Cohort 1b) with DMD gene mutation in exons 12-17. * Participant is able to walk 100 meters independently without assistive devices. Cohort 2c participant must be able to walk 10 meters independently without assistive devices. Cohort 1b participant must be able to walk with or without assistive devices. * Participant is able to complete the TTSTAND per protocol-specific criteria. * Participant has been on a stable dose of systemic glucocorticoids according to the standard of care for at least 12 weeks. Cohort 2c participants must be consistently on or off a stable dose of systemic glucocorticoids according to the standard of care for at least 12 weeks. * Clinical laboratory test results, including hepatic and renal function, are within the normal range during screening, or if abnormal, are not clinically significant, in the opinion of the investigator. * Documentation is provided at screening visit for participant's adherence to the local country's vaccination schedule. The parent(s) or legal guardian(s) must be willing to have their child receive a meningococcal vaccine, if not already vaccinated. * Participant and parent(s)/legal guardian(s) are willing and able to comply with scheduled visits, study intervention administration plan, and study procedures. Part 2 and 3
Inclusion Criteria:
* The participant's legal guardian(s) is (are) willing and able to provide written, signed informed consent prior to any study-related procedures; and, where applicable, the minor participant has provided written or verbal assent according to local requirements. * DMD gene mutation with any mutation except for those with deletions or point mutations in exons 8, 9 and/or 10. * Participant is able to complete the TTSTAND per protocol-specific criteria. * Clinical laboratory test results, including hepatic and renal function, are within the normal range during screening, or if abnormal, are not clinically significant, in the opinion of the investigator. * Documentation is provided at screening visit for participant's adherence to the local country's vaccination schedule. The parent(s) or legal guardian(s) must be willing to have their child receive a meningococcal vaccine, if not already vaccinated. * Participant and parent(s)/legal guardian(s) are willing and able to comply with scheduled visits, study intervention administration plan, and study procedures. * Is a male at least 1 year of age and ≥ 10 kg at the time of screening. * Participants 1 to \<4 years of age must meet the following criteria: * is able to walk 10 meters independently without assistive devices. * must be consistently on or off a stable dose of systemic glucocorticoids according to the standard of care for at least 12 weeks. * Participants 4 years and older must meet the following criteria: * are able to walk 100 meters independently without assistive devices. * have been on a stable dose of systemic glucocorticoids according to the standard of care for at least 12 weeks. * have a NSAA total score ≥16. Part 1
Exclusion Criteria:
* Participant has any condition that would contraindicate treatment with immunosuppression. * Participant has received ataluren (a protein restoration therapy) or an exon-skipping therapy for the treatment of DMD within 6 months of study entry or is unable to refrain from taking ataluren or exon-skipping therapy for a duration of 5 years from the time of RGX-202 administration. * Participant has received any investigational or commercial gene therapy product over his lifetime. * Participant is currently taking any other investigational intervention (other than corticosteroids) or has taken any other investigational intervention (other than corticosteroids) within 3 months prior to the scheduled Day 1 intervention. If your corticosteroid is vamorolone, the participant will be asked to temporarily convert his daily dosing to prednisolone/prednisone during a short period of time around RGX-202 administration. He will be allowed to revert back to his baseline vamorolone regimen at the original per kilogram dose at which he entered the study and should remain on this for 24 months unless the investigator determines that this is not clinically indicated or possible. * Participant has impaired cardiac function defined as a left ventricular ejection fraction of \< 55% on screening cardiac assessments (echocardiogram or MRI). * Participant is not a good candidate for the study, in the opinion of the investigator. Part 2 and 3
Exclusion Criteria:
* Participant has any condition that would contraindicate treatment with immunosuppression. * Participant has received givinostat within 3 months of study entry or has received ataluren (a protein restoration therapy) or an exon-skipping therapy for the treatment of DMD within 6 months of study entry or is unable to refrain from taking ataluren or exon-skipping therapy for a duration of 5 years from the time of RGX-202 administration. * Participant has received any investigational or commercial gene therapy product over his lifetime. * Participant is currently taking any other investigational intervention (other than corticosteroids) or has taken any other investigational intervention (other than corticosteroids) within 3 months prior to the scheduled Day 1 intervention. If your corticosteroid is vamorolone, the participant will be asked to temporarily convert his daily dosing to prednisolone/prednisone during a short period of time around RGX-202 administration. He will be allowed to revert back to his baseline vamorolone regimen at the original per kilogram dose at which he entered the study and should remain on this for 24 months unless the investigator determines that this is not clinically indicated or possible. * Participant has detectable AAV8 total binding antibodies in serum. * Participant has impaired cardiac function defined as a left ventricular ejection fraction of \< 55% on screening cardiac assessments echocardiogram or MRI). * Participant is not a good candidate for the study, in the opinion of the investigator.
GENETIC: RGX-202
Duchenne Muscular Dystrophy
Gene therapy, DMD, Duchenne Muscular Dystrophy, Duchenne
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Alberta Children's Hospital Calgary, Alberta Israt Yasmeen, MBT - (Israt.Yasmeen@ahs.ca)
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois Nicole Geanous - (ngeanous@luriechildrens.org)
Arkansas Children's Hospital Little Rock, Arkansas Amber Evans - (evansa17@archildrens.org)
BC Children's Hospital Vancouver, British Columbia Nela Martic - (NMartic3@cw.bc.ca)
Children's Hospital Colorado Aurora, Colorado Michele Yang - (Michele.Yang@childrenscolorado.org) Hannah Kleiner - (Hannah.Kleiner@childrenscolorado.org)
Children's Hospital London Health Science Centre London, Ontario Rhiannon Hicks - (rhiannon.hicks@lhsc.on.ca)
Children's Hospital Of Eastern Ontario Ottawa, Ontario Laura Thompson - (lathompson@cheo.on.ca)
Children's Hospital of Richmond at Virginia Commonwealth University Richmond, Virginia Falgun Patel - (Falgun.Patel@vcuhealth.org)
Children's Hospital of the King's Daughters Norfolk, Virginia Erika Paradiso - (proud.research@chkd.org)
Cincinnati Children's Cincinnati, Ohio Angela Edmondson - (Angela.Edmondson@cchmc.org)
Oregon Health & Science University Portland, Oregon Beata Dyar - (dyar@ohsu.edu)
Rare Disease Research Atlanta, Georgia Lily Goggans - (lily.goggans@rarediseaseresearch.com) Maureen Ikpeoha - (maureen.ikpeoha@rarediseaseresearch.com)
Stanford School of Medicine /Division of Neuromuscular Medicine Palo Alto, California - (neuromuscularresearch@stanford.edu)
The University of Texas Southwestern Medical Center Dallas, Texas Elaine Most - (elaine.most@utsouthwestern.edu)
University of Florida Gainesville, Florida Melissa Lewis - (melissa.lewis@peds.ufl.edu)
University of Iowa Iowa City, Iowa Laura Knosp - (laura-knosp@uiowa.edu)
University of Massachusetts Chan Medical School Worcester, Massachusetts Tyler Mola - (tyler.mola@umassmed.edu)

A Study Using Nivolumab, in Combination With Chemotherapy Drugs to Treat Nasopharyngeal Carcinoma (NPC)

ctrrecruit@vcu.edu

NCT06064097
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Inclusion Criteria:
* Patients must be ≤ 21 years of age at the time of study enrollment * Newly diagnosed American Joint Committee on Cancer (AJCC) stage II-IV nasopharyngeal carcinoma (NPC) * Patients must have had histologic verification of the malignancy at original diagnosis * Although submission of tumor tissue for the molecular characterization initiative is not required for eligibility, it is strongly recommended * Patients must have had histologic verification of the malignancy at original diagnosis * Although submission of tumor tissue for the molecular characterization initiative is not required for eligibility, it is strongly recommended * Patients must have a Lansky (for patients ≤ 16 years of age) or Karnofsky (for patients \> 16 years of age) performance status score of ≥ 60% * Peripheral absolute neutrophil count (ANC) ≥ 1000/uL (within 7 days prior to start of protocol therapy) * Platelet count ≥ 100,000/uL (transfusion independent) (within 7 days prior to start of protocol therapy) * Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m\^2 or (within 7 days prior to start of protocol therapy) * A serum creatinine based on age/sex (within 7 days prior to start of protocol therapy) Age: Maximum serum creatinine (mg/dL) 1 month to \< 6 months: 0.4 mg/dL (male); 0.4 mg/dL (female) 6 months to \< 1 year: 0.5 mg/dL (male); 0.5 mg/dL (female) 1 to \< 2 years: 0.6 mg/dL (male); 0.6 mg/dL (female) 2 to \< 6 years: 0.8 mg/dL (male); 0.8 mg/dL (female) 6 to \< 10 years 1 mg/dL (male); 1 mg/dL (female) 10 to \<13 years: 1.2 mg/dL (male); 1.2 mg/dL (female) 13 to \< 16 years: 1.5 mg/dL (male); 1.4 mg/dL (female) ≥ 16 years: 1.7 mg/dL (male); 1.4 mg/dL (female) * Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age, and (within 7 days prior to start of protocol therapy) * Serum glutamic-pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) ≤ 135 U/L\* (within 7 days prior to start of protocol therapy) * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L * Shortening fraction of ≥ 27% by echocardiogram, or * Ejection fraction of ≥ 50% by radionuclide angiogram * No evidence of dyspnea at rest, no exercise intolerance, and a pulse oximetry \> 94% if there is clinical indication for determination * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months and T-cell count above the lower limit of normal are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
Exclusion Criteria:
* Patients who received prior radiotherapy to the head or neck * Patients who received prior chemotherapy or radiation for the treatment of any cancer in the last 3 years. These patients must also be in remission * Patients with a diagnosis of immunodeficiency * Patients with an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive agents). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. * Note: Patients with well-controlled asthma and no need for systemic steroids for the treatment of asthma in the last 12 months will not be excluded * Patients with a condition requiring systemic treatment with either corticosteroids (\> 0.25 mg/kg (10 mg) daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of enrollment. Inhaled or topical steroids, and adrenal replacement steroid doses \> 0.25 mg/kg (10 mg) daily prednisone equivalent, are permitted in the absence of active autoimmune disease * Patients with a history of (non-infectious) pneumonitis that required steroids or current pneumonitis * Patients with detectable viral load of human immunodeficiency virus (HIV), hepatitis B or hepatitis C, or active tuberculosis * Patients who have undergone solid organ or allogeneic hematopoietic transplant at any time * Due to risks of fetal and teratogenic adverse events as seen in animal studies, a negative pregnancy test must be obtained in females of childbearing potential, defined as females who are post-menarchal. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required * Females of childbearing potential that are sexually active must agree to either practice 2 medically accepted highly-effective methods of contraception at the same time or abstain from heterosexual intercourse from the time of signing the informed consent through 5 months after the last dose of nivolumab, 6 months after the last dose of gemcitabine, and 14 months after the last dose of cisplatin, whichever is longer * Males of childbearing potential that are sexually active must agree to either practice a medically accepted highly-effective methods of contraception or abstain from heterosexual intercourse from the time of signing the informed consent through 3 months after the last dose of gemcitabine, and 11 months after the last dose of cisplatin, whichever is longer * Lactating females are not eligible unless they have agreed not to breastfeed their infants starting with the first dose of study therapy through 5 months after the last dose of nivolumab * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, PROCEDURE: Chest Radiography, DRUG: Cisplatin, PROCEDURE: Computed Tomography, PROCEDURE: Echocardiography Test, OTHER: Electronic Health Record Review, OTHER: Fluciclovine F18, DRUG: Gemcitabine, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Multigated Acquisition Scan, BIOLOGICAL: Nivolumab, PROCEDURE: Positron Emission Tomography, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration, RADIATION: Radiation Therapy, PROCEDURE: X-Ray Imaging
Stage II Nasopharyngeal Carcinoma AJCC v8, Stage III Nasopharyngeal Carcinoma AJCC v8, Stage IV Nasopharyngeal Carcinoma AJCC v8
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Albany Medical Center Albany, New York
Alberta Children's Hospital Calgary, Alberta Site Public Contact - (research4kids@ucalgary.ca)
Alfred I duPont Hospital for Children Wilmington, Delaware Site Public Contact - (Allison.bruce@nemours.org)
Arkansas Children's Hospital Little Rock, Arkansas
Arnold Palmer Hospital for Children Orlando, Florida Site Public Contact - (Jennifer.spinelli@orlandohealth.com)
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas Site Public Contact - (burton@bcm.edu)
Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina
Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec Site Public Contact - (yvan.samson@umontreal.ca)
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca)
Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia Site Public Contact - (Olivia.Floyd@choa.org)
Children's Hospital Colorado Aurora, Colorado
Children's Hospital New Orleans New Orleans, Louisiana
Children's Hospital and Medical Center of Omaha Omaha, Nebraska
Children's Hospital of Alabama Birmingham, Alabama Site Public Contact - (oncologyresearch@peds.uab.edu)
Children's Hospital of Philadelphia Philadelphia, Pennsylvania Site Public Contact - (CancerTrials@email.chop.edu)
Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania Site Public Contact - (jean.tersak@chp.edu)
Children's Hospital of San Antonio San Antonio, Texas Site Public Contact - (bridget.medina@christushealth.org)
Children's Hospital of Wisconsin Milwaukee, Wisconsin Site Public Contact - (MACCCTO@mcw.edu)
Children's Hospital of the King's Daughters Norfolk, Virginia Site Public Contact - (CCBDCresearch@chkd.org)
Children's Mercy Hospitals and Clinics Kansas City, Missouri Site Public Contact - (COGResearchGroup@cmh.edu)
Children's National Medical Center Washington D.C., District of Columbia Site Public Contact - (OncCRC_OnCall@childrensnational.org)
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio Site Public Contact - (cancer@cchmc.org)
Connecticut Children's Medical Center Hartford, Connecticut
Cook Children's Medical Center Fort Worth, Texas Site Public Contact - (CookChildrensResearch@cookchildrens.org)
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Dayton Children's Hospital Dayton, Ohio
Dell Children's Medical Center of Central Texas Austin, Texas Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org)
Duke University Medical Center Durham, North Carolina
East Carolina University Greenville, North Carolina Site Public Contact - (eubankss@ecu.edu)
Hackensack University Medical Center Hackensack, New Jersey
Hospital for Sick Children Toronto, Ontario Site Public Contact - (ask.CRS@sickkids.ca)
Jersey Shore Medical Center Neptune City, New Jersey
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Kaiser Permanente Downey Medical Center Downey, California
Kaiser Permanente-Oakland Oakland, California Site Public Contact - (Kpoct@kp.org)
Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Loma Linda University Medical Center Loma Linda, California
Lurie Children's Hospital-Chicago Chicago, Illinois
M D Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
Maine Children's Cancer Program Scarborough, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
Mary Bridge Children's Hospital and Health Center Tacoma, Washington Site Public Contact - (research@multicare.org)
Mayo Clinic in Rochester Rochester, Minnesota
Nationwide Children's Hospital Columbus, Ohio Site Public Contact - (Melinda.Triplet@nationwidechildrens.org)
Nemours Children's Clinic - Pensacola Pensacola, Florida Site Public Contact - (helpdesk@childrensoncologygroup.org)
Nemours Children's Clinic-Jacksonville Jacksonville, Florida Site Public Contact - (Allison.bruce@nemours.org)
Nemours Children's Hospital Orlando, Florida Site Public Contact - (Allison.bruce@nemours.org)
Newark Beth Israel Medical Center Newark, New Jersey Site Public Contact - (Christine.Kosmides@rwjbh.org)
Nicklaus Children's Hospital Miami, Florida
Penn State Children's Hospital Hershey, Pennsylvania
Phoenix Childrens Hospital Phoenix, Arizona
Prisma Health Richland Hospital Columbia, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Rady Children's Hospital - San Diego San Diego, California
Rainbow Babies and Childrens Hospital Cleveland, Ohio
Riley Hospital for Children Indianapolis, Indiana
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick, New Jersey
Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida Site Public Contact - (jennifer.manns@baycare.org)
Saint Jude Children's Research Hospital Memphis, Tennessee Site Public Contact - (referralinfo@stjude.org)
Sanford Broadway Medical Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org)
Seattle Children's Hospital Seattle, Washington
Starship Children's Hospital Grafton, Auckland
The Children's Hospital at TriStar Centennial Nashville, Tennessee
The Montreal Children's Hospital of the MUHC Montreal, Quebec Site Public Contact - (info@thechildren.com)
UCSF Benioff Children's Hospital Oakland Oakland, California Site Public Contact - (PedOncRschOAK@ucsf.edu)
UCSF Medical Center-Mission Bay San Francisco, California Site Public Contact - (cancertrials@ucsf.edu)
UF Health Cancer Institute - Gainesville Gainesville, Florida Site Public Contact - (cancer-center@ufl.edu)
UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas Site Public Contact - (canceranswerline@UTSouthwestern.edu)
University Pediatric Hospital San Juan,
University of Alberta Hospital Edmonton, Alberta Site Public Contact - (pedsoncologyresearch@ahs.ca)
University of Chicago Comprehensive Cancer Center Chicago, Illinois Site Public Contact - (cancerclinicaltrials@bsd.uchicago.edu)
University of Kentucky/Markey Cancer Center Lexington, Kentucky
University of Mississippi Medical Center Jackson, Mississippi
University of Nebraska Medical Center Omaha, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Virginia Cancer Center Charlottesville, Virginia Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Valley Children's Hospital Madera, California Site Public Contact - (Research@valleychildrens.org)
Vanderbilt University/Ingram Cancer Center Nashville, Tennessee
Washington University School of Medicine St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)

The AIRTIVITY™ Study: A Study to Find Out Whether BI 1291583 Helps People With Bronchiectasis

Boehringer Ingelheim - clintriage.rdg@boehringer-ingelheim.com

NCT06872892
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Inclusion criteria: * Male or female participants. Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per International Council of Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1 % per year when used consistently and correctly, as well as one barrier method. A list of contraception methods meeting these criteria is provided in the participant information. * Signed and dated written informed consent and assent, if applicable, prior to admission to the study, in accordance with GCP and local legislation. * Age of participants when signing the informed consent/assent ≥12 years. \-- Adolescents need to weigh at least 35 kg at Visit 1. * Clinical history consistent with bronchiectasis (e.g. cough, chronic sputum production, recurrent respiratory infections) and investigator confirmed diagnosis of bronchiectasis by CT scan where bronchiectasis has been documented by a radiologist. Participants whose past CT scan image records are not available will undergo a chest CT scan during Screening. Historical scans must not be older than five years. * Adult participants should be able to produce sputum for Pseudomonas aeruginosa assessment during the screening period. * History of documented pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, participants must have had either: * at least 2 exacerbations, or * at least 1 exacerbation and an St. George's Respiratory Questionnaire (SGRQ) Symptoms score of \>40 at screening Visit 1 (adults only) * at least 1 exacerbation and high symptom burden according to the investigator's judgement (adolescents only) For participants on oral or inhaled antibiotics as chronic treatment for bronchiectasis and participants on Cystic Fibrosis Transmembrane Conductance Regulator Modulator Therapy (CFTR-MT), at least one exacerbation must have occurred since initiation of antibiotics or CFTR-MT. Exclusion criteria: * Any new or newly diagnosed condition of primary or secondary immunodeficiency within 1 year before randomisation. * Allergic bronchopulmonary aspergillosis being treated or requiring treatment. * Tuberculosis or non-tuberculosis mycobacterial infection being treated or requiring treatment * Any findings in the medical examination and/or laboratory value assessed at Screening Visit 1 or during screening period, that in the opinion of the investigator may put the participant at risk by participating in the trial. * Any clinically relevant (at the discretion of the investigator) acute respiratory infection or ongoing pulmonary exacerbation at screening visit or during the screening unless recovered in the opinion of the investigator prior to Visit 2. * Any relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, hormonal, or other disorder that, in the opinion of the investigator, may put the participant at risk by participating in the study. * Major surgery (major according to the investigator's assessment) performed within 6 weeks prior to randomisation or scheduled during trial period. * Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated in situ non-melanoma skin cancers or in situ carcinoma of uterine cervix. * Evidence or medical history of moderate or severe liver disease (Child-Pugh score B or C hepatic impairment). * estimated Glomerular Filtration Rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula (adults) or Chronic Kidney Disease Under 25 (CKiD-U25) (adolescents) \<30 mL/min at Visit 1. * Previous treatment with a dipeptidyl peptidase-1 (DPP1) (Cathepsin C (CatC)) inhibitor. (Note: Participants that were randomised and only received placebo in studies with DPP1 (CatC) inhibitor are allowed.) Further exclusion criteria apply.
DRUG: BI 1291583, DRUG: Placebo matching BI 1291583
Bronchiectasis
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A.O. dei Colli Napoli, Boehringer Ingelheim - (italia@bitrialsupport.com)
A.O.U.Policlinico G.Martino Messina, Boehringer Ingelheim - (italia@bitrialsupport.com)
AOU Policlinico G. Rodolico San Marco Catania, Boehringer Ingelheim - (italia@bitrialsupport.com)
AOU San Luigi Gonzaga Orbassano (TO), Boehringer Ingelheim - (italia@bitrialsupport.com)
APRILLUS-Asistencia e Investigacion Ciudad Autonoma Buenos Aires, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Aalborg Sygehus Syd Aalborg, Boehringer Ingelheim - (danmark@bitrialsupport.com)
Aarhus University Hospital Aarhus, Boehringer Ingelheim - (danmark@bitrialsupport.com)
Addington Hospital Durban, Boehringer Ingelheim - (southafrica@bitrialsupport.com)
Adnan Menderes Üniversitesi Aydin, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Affiliated Hospital of Nantong University Nantong, Boehringer Ingelheim - (china@bitrialsupport.com)
Affiliated Hospital, Xuzhou Medical college Xuzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
Ain Shams University Clinical Research Center (MASRI) Cairo, Boehringer Ingelheim - (support@bitrialsupport.com)
Air Force Specialized Hospital Cairo, Boehringer Ingelheim - (support@bitrialsupport.com)
Akdeniz Universitesi Tip Fakultesi Antalya, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Akron Children's Hospital Akron, Ohio Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Alfred Hospital Melbourne, Victoria Boehringer Ingelheim - (australia@bitrialsupport.com)
Altamed Specjalistyczna Praktyka Lekarska Pawel Sliwinski Warsaw, Boehringer Ingelheim - (polska@bitrialsupport.com)
Amsterdam UMC Locatie VUMC Amsterdam, Boehringer Ingelheim - (nederland@bitrialsupport.com)
Ankara University Medical Faculty Ankara, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Arke SMO S.A. de C.V. Veracruz de Ignacio de La Llave, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Asan Medical Center Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Asklepios Fachkliniken München-Gauting Gauting, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Aso Co.,Ltd Iizuka Hospital Fukuoka, Iizuka, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Asociación Mexicana para la Investigacion Clínica, A.C(AMIC) Pachuca, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Augusta University Augusta, Georgia Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Augustiner Krankenhäuser GmbH Cologne, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Azienda Ospedaliera San Martino Genova, Boehringer Ingelheim - (italia@bitrialsupport.com)
Azienda Ospedaliera Universitaria Integrata Verona Verona, Boehringer Ingelheim - (italia@bitrialsupport.com)
Azienda Ospedaliera Universitaria di Padova Padua, Boehringer Ingelheim - (italia@bitrialsupport.com)
Azienda Ospedaliero Universitaria delle Marche Ancona, Boehringer Ingelheim - (italia@bitrialsupport.com)
Azienda Socio Sanitaria Territoriale Di Monza Monza (MB), Boehringer Ingelheim - (italia@bitrialsupport.com)
B. P. Poddar Hospital and Medical Research Limited Kolkata, Boehringer Ingelheim - (india@bitrialsupport.com)
BAG Wiesbaden Wiesbaden, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
BKS Research Ltd Hatvan, Boehringer Ingelheim - (magyarorszag@bitrialsupport.com)
BLC Clinical Research Burlington, Ontario Boehringer Ingelheim - (canada@bitrialsupport.com)
Baylor University Medical Center Dallas, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Beijing Children's Hospital, Capital Medical University Beijing, Boehringer Ingelheim - (china@bitrialsupport.com)
Belfast City Hospital Belfast, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Blackpool Victoria Hospital Blackpool, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Bradford Royal Infirmary Bradford, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
CAPRISA Offices on the King DinuZulu Hospital Complex Springfield, Boehringer Ingelheim - (southafrica@bitrialsupport.com)
CEDIC - Centro de Investigacion Clinica CABA, Boehringer Ingelheim - (argentina@bitrialsupport.com)
CHU Amiens-Picardie Amiens, Boehringer Ingelheim - (france@bitrialsupport.com)
CIMS Studienzentrum Bamberg GmbH Bamberg, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
CRC-Alexandria University Alexandria, Boehringer Ingelheim - (support@bitrialsupport.com)
CTC Clinical Trial Consultants AB Uppsala, Boehringer Ingelheim - (sverige@bitrialsupport.com)
Canberra Hospital Garran, Boehringer Ingelheim - (australia@bitrialsupport.com)
Cardio 1 Medical Clinic Winnipeg, Manitoba Boehringer Ingelheim - (canada@bitrialsupport.com)
Caritas-Krankenhaus St. Maria gGmbH Donaustauf, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Central Florida Pulmonary Group Altamonte Springs, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Centre Hospitalier de L'Universite de Montreal (CHUM) Montreal, Quebec Boehringer Ingelheim - (canada@bitrialsupport.com)
Centro Dr. Lazaro Langer S.R.L Alberdi Sur, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Centro Hospitais da Universidade de Coimbra Coimbra, Boehringer Ingelheim - (portugal@bitrialsupport.com)
Centro Respiratorio de Quilmes Quilmes, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Centro de Enfermedades Cardiovasculares (CEC) Bahía Blanca, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Centro de Estudios Clínicos CEC Santiago, Boehringer Ingelheim - (chile@bitrialsupport.com)
Centro de Investigacion Farmacologica del Bajío, S.C. León, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Centro de Investigacion Integral MEDIVEST S.C Chihuahua City, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Centro de Investigación Clinica Belgrano CABA, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Centro de Investigación del Maule Talca, Boehringer Ingelheim - (chile@bitrialsupport.com)
Chang Gung Memorial Hospital, Linkou Taoyuan, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
Changi General Hospital Singapore, Boehringer Ingelheim - (singapore@bitrialsupport.com)
Charite - Universitatsmedizin Berlin Berlin, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Charite - Universitatsmedizin Berlin Berlin, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Chiba University Hospital Chiba, Chiba Boehringer Ingelheim - (nippon@bitrialsupport.com)
China-Japan Friendship Hospital Beijing, Boehringer Ingelheim - (china@bitrialsupport.com)
Christchurch Hospital Christchurch, Boehringer Ingelheim - (newzealand@bitrialsupport.com)
Chronos Pesquisa Clinica Brasília, Boehringer Ingelheim - (brasil@bitrialsupport.com)
Chungbuk National University Hospital Cheongju-si, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Cleveland Clinic Florida Weston, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Clinical Hospital Centar Sestre Milosrdnice Zagreb, Boehringer Ingelheim - (hrvatska@bitrialsupport.com)
Clinical Hospital Centre Zagreb Zagreb, Boehringer Ingelheim - (hrvatska@bitrialsupport.com)
Clinical Hospital Of Infectious Diseases And Pneumophysiology Dr.Victor Babes Timisoara Timișoara, Boehringer Ingelheim - (romania@bitrialsupport.com)
Clinical Hospital of Pneumophysiology Leon Daniello Cluj-Napoca, Boehringer Ingelheim - (romania@bitrialsupport.com)
Clinical Research Associates of Central PA DuBois, Pennsylvania Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Clinical Research Institute S.C. Tlalnepantla, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Clinical Research of Rock Hill Rock Hill, South Carolina Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Cliniques Universitaires Saint-Luc Brussels, Boehringer Ingelheim - (belgique@bitrialsupport.com)
Columbia University Medical Center-New York Presbyterian Hospital New York, New York Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Complejo Hospitalario Universitario A Coruna A Coruña, Boehringer Ingelheim - (espana@bitrialsupport.com)
Complejo Hospitalario de Navarra Pamplona, Boehringer Ingelheim - (espana@bitrialsupport.com)
Complexo Hospitalario Universitario De Santiago Santiago de Compostela, Boehringer Ingelheim - (espana@bitrialsupport.com)
Concord Repatriation General Hospital Concord, New South Wales Boehringer Ingelheim - (australia@bitrialsupport.com)
Connolly Hospital Blanchardstown Dublin, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Copenhagen University Hospital, Rigshospitalet København Ø, Boehringer Ingelheim - (danmark@bitrialsupport.com)
Cork University Hospital Cork, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Craigavon Area Hospital Portadown, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Da Vinci Private Clinic Pécs, Boehringer Ingelheim - (magyarorszag@bitrialsupport.com)
Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Daugavpils Regional Hospital LTD Centre Outpatient Clinic Daugavpils, Boehringer Ingelheim - (latvia@bitrialsupport.com)
Diagnostics And Consultation Center Convex Ltd. Sofia, Boehringer Ingelheim - (balgariya@bitrialsupport.com)
Diex Recherche (Sherbrooke Est) Sherbrooke, Quebec Boehringer Ingelheim - (canada@bitrialsupport.com)
Diex Recherche (Trois-Rivieres) Trois-Rivières, Quebec Boehringer Ingelheim - (canada@bitrialsupport.com)
Dignity Health, St. Joseph's Hospital and Medical Center Phoenix, Arizona Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Dr Ismail Abdullah Cape Town, Boehringer Ingelheim - (southafrica@bitrialsupport.com)
EMED, Center of Medical Services,Private Prac,Rzeszow Rzeszów, Boehringer Ingelheim - (polska@bitrialsupport.com)
Eastern Health-Box Hill Hospital Box Hill, Victoria Boehringer Ingelheim - (australia@bitrialsupport.com)
El Paso Pulmonary Association El Paso, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Element Research Group San Antonio, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Emory University Atlanta, Georgia Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Enhancing Care Foundation NPC Mount Edgecombe, Boehringer Ingelheim - (southafrica@bitrialsupport.com)
Equipo Ciencia Buenos Aires, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Erasmus Medisch Centrum-ROTTERDAM-50697 Rotterdam, Boehringer Ingelheim - (nederland@bitrialsupport.com)
Essence MD Research Naples, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Evangelische Lungenklinik Berlin Berlin, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Faculdade de Medicina de Botucatu - UNESP Botucatu, Boehringer Ingelheim - (brasil@bitrialsupport.com)
First Affiliated Hospital of Guangzhou Medical University Guangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
First Affiliated Hospital of Xi'an JiaoTong University Xi'an, Boehringer Ingelheim - (china@bitrialsupport.com)
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico Milan, Boehringer Ingelheim - (italia@bitrialsupport.com)
Fondazione IRCCS Policlinico S. Matteo Pavia, Boehringer Ingelheim - (italia@bitrialsupport.com)
Freeman Hospital Newcastle upon Tyne, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Froedtert and The Medical College of Wisconsin Milwaukee, Wisconsin Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Fukujuji Hospital Tokyo, Kiyose, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Fukuoka Children's Hospital Fukuoka, Fukuoka, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Fukuoka University Hospital Fukuoka, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Gelre Ziekenhuis Zutphen Zutphen, Boehringer Ingelheim - (nederland@bitrialsupport.com)
Georgetown University Washington D.C., District of Columbia Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Government Hospital for Chest and Communicable Diseases (GHCCD) Visakhapatnam, Boehringer Ingelheim - (india@bitrialsupport.com)
Greenslopes Private Hospital Greenslopes, Queensland Boehringer Ingelheim - (australia@bitrialsupport.com)
Guangdong Provincial People's Hospital Guangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
Guizhou People's Hospital Guiyang, Boehringer Ingelheim - (china@bitrialsupport.com)
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás Goiânia, Boehringer Ingelheim - (brasil@bitrialsupport.com)
HOP Arnaud de Villeneuve Montpellier, Boehringer Ingelheim - (france@bitrialsupport.com)
HOP Croix-Rousse Lyon, Boehringer Ingelheim - (france@bitrialsupport.com)
HOP Haut-Lévêque Pessac, Boehringer Ingelheim - (france@bitrialsupport.com)
HOP Intercommunal Créteil, Boehringer Ingelheim - (france@bitrialsupport.com)
HOP Larrey Tououse, Boehringer Ingelheim - (france@bitrialsupport.com)
HOP Nord Laennec Saint-Herblain, Boehringer Ingelheim - (france@bitrialsupport.com)
HOP Pasteur Nice, Boehringer Ingelheim - (france@bitrialsupport.com)
HOP Pontchaillou Rennes, Boehringer Ingelheim - (france@bitrialsupport.com)
Hadassah Medical Center, Ein-Karem Jerusalem, Boehringer Ingelheim - (israel@bitrialsupport.com)
Hadassah Medical Center, Ein-Karem Jerusalem, Boehringer Ingelheim - (israel@bitrialsupport.com)
Haga Ziekenhuis The Hague, Boehringer Ingelheim - (nederland@bitrialsupport.com)
Hallym University Kangnam Sacred Heart Hospital Seoul, Seoul-teukbyeolsi [seoul] Boehringer Ingelheim - (namhan@bitrialsupport.com)
Hallym University Sacred Heart Hospital Anyang-si, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Hamamatsu University Hospital Shizuoka, Hamamatsu, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Hangzhou First People's Hospital Hangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
Hanyang University Medical Center Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Health Cube Medical Clinics Mandaluyong, Boehringer Ingelheim - (pilipinas@bitrialsupport.com)
Health Partners Specialty Saint Paul, Minnesota Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Heart of Australia Research Institute Chelmer, Queensland Boehringer Ingelheim - (australia@bitrialsupport.com)
Heartlands Hospital Birmingham, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Helios Hanseklinikum Stralsund Stralstund, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Helsinki University Hospital Helsinki, Boehringer Ingelheim - (suomi@bitrialsupport.com)
Hirosaki University Hospital Aomori, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Hokkaido University Hospital Sapporo, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Hopital Cochin Paris, Boehringer Ingelheim - (france@bitrialsupport.com)
Horizon Clinical Research Group Cypress, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Hospital Aleman Recoleta, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Hospital Central de Asturias Oviedo, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Clinic de Barcelona Barcelona, Barcelona Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Germans Trias I Pujol Badalona, Barcelona [barcelona] Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Hietzing Vienna, Boehringer Ingelheim - (oesterreich@bitrialsupport.com)
Hospital Infanta Elena Huelva, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Jerez de la Frontera Jerez de la Frontera, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Politècnic La Fe Valencia, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Quirónsalud Madrid Pozuelo de Alarcón, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Raja Perempuan Zainab II Kelantan, Boehringer Ingelheim - (malaysia@bitrialsupport.com)
Hospital Son Espases Palma de Mallorca, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Sultan Idris Shah Serdang Kajang, Boehringer Ingelheim - (malaysia@bitrialsupport.com)
Hospital Sultanah Bahiyah Alor Setar, Kedah, Boehringer Ingelheim - (malaysia@bitrialsupport.com)
Hospital Universitari Vall d Hebron Barcelona, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universitari de Bellvitge L'Hospitalet de Llobregat, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universitari de Girona Doctor Josep Trueta Girona, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universitario Dr Jose Eleuterio Gonzalez Nuevo León, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Hospital Universitario Dr Jose Eleuterio Gonzalez Nuevo León, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Hospital Universitario La Paz Madrid, Madrid, Comunidad de Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universitario Marqués de Valdecilla Santander, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universitario Puerto Real Puerto Real, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universitario Virgen De La Macarena Seville, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Universitario Virgen de la Arrixaca EL Palmar (EL Palmar), Murcia Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital Virgen del Rocio Seville, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital de Mérida Mérida, Boehringer Ingelheim - (espana@bitrialsupport.com)
Hospital of Lithuanian University of Health Sciences Kauno Klinikos Kaunas, Boehringer Ingelheim - (lithuania@bitrialsupport.com)
Huadong Hospital Affiliated to Fudan University Shanghai, Boehringer Ingelheim - (china@bitrialsupport.com)
Huzhou Central Hospital Huzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
Hvidovre Hospital Hvidovre, Boehringer Ingelheim - (danmark@bitrialsupport.com)
IKF Pneumologie GmbH & Co. KG Frankfurt, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
INCOR e Hospital das Clínicas da Universidade de São Paulo São Paulo, Boehringer Ingelheim - (brasil@bitrialsupport.com)
INS Coeur Poumon Lille, Boehringer Ingelheim - (france@bitrialsupport.com)
Iatros International Bloemfontein, Boehringer Ingelheim - (southafrica@bitrialsupport.com)
Ibamedica Santa Fe, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Icahn School of Medicine at Mount Sinai New York, New York Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Iloilo Doctors Hospital Iloilo City, Boehringer Ingelheim - (pilipinas@bitrialsupport.com)
Indiana University Indianapolis, Indiana Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Inmedica Vilnius, Boehringer Ingelheim - (lithuania@bitrialsupport.com)
Inova Fairfax Medical Campus Falls Church, Virginia Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Institut Perubatan Respiratori Kuala Lumpur, Boehringer Ingelheim - (malaysia@bitrialsupport.com)
Institut Universitaire de Cardiologie et de Pneumologie de Quebec Québec, Boehringer Ingelheim - (canada@bitrialsupport.com)
Institute for Respiratory Health Nedlands, Western Australia Boehringer Ingelheim - (australia@bitrialsupport.com)
Institute of Science Tokyo Hospital Bunkyō City, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Instituto Ave Pulmo Mar del Plata, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Instituto de Especialidades de la Salud Rosario Rosario, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Intermountain Healthcare Salt Lake City, Utah Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Irmandade da Santa Casa de Misericordia de Porto Alegre Porto Alegre, Rio Grande do Sul Boehringer Ingelheim - (brasil@bitrialsupport.com)
Istanbul University Medical Faculty Capa Hospital Istanbul, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Istituto Clinico Humanitas Rozzano, Boehringer Ingelheim - (italia@bitrialsupport.com)
Istituto G. Gaslini Genova, Boehringer Ingelheim - (italia@bitrialsupport.com)
Jawahar Lal Nehru Medical College Ajmer, Boehringer Ingelheim - (india@bitrialsupport.com)
Jefferson Health Honickman Center Philadelphia, Pennsylvania Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Jeonbuk National University Hospital Jeonju, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Jiangmen Central Hospital Jiangmen, Boehringer Ingelheim - (china@bitrialsupport.com)
Johns Hopkins Hospital Baltimore, Maryland Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Kagoshima University Hospital Kagoshima, Kagoshima, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Kameda Clinic Chiba, Kamogawa, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Kanagawa Cardiovascular and Respiratory Center Yokohama, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Kangdong Sacred Heart Hospital Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Kaohsiung Chang Gung Memorial Hospital Kaohsiung City, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung City, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
Karolinska University Hospital Stockholm, Boehringer Ingelheim - (sverige@bitrialsupport.com)
Kasr Al Aini, Cairo University Cairo, Boehringer Ingelheim - (support@bitrialsupport.com)
Katholisches Klinikum Bochum gGmbH Bochum, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Keio University Hospital Tokyo, Boehringer Ingelheim - (nippon@bitrialsupport.com)
King Chulalongkorn Memorial Hospital Thailand, Boehringer Ingelheim - (thai@bitrialsupport.com)
King's College Hospital London, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Klinikum Dortmund gGmbH Dortmund, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Klinikum Wels - Grieskirchen GmbH Wels, Boehringer Ingelheim - (oesterreich@bitrialsupport.com)
Klinikum Westbrandenburg GmbH Potsdam, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Klinikum der Universität München AÖR München, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Konkuk University Medical Center Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Koranyi National Institute For Pulmonolgy Budapest, Boehringer Ingelheim - (magyarorszag@bitrialsupport.com)
Korea University Guro Hospital Seoul, Seoul-teukbyeolsi [seoul] Boehringer Ingelheim - (namhan@bitrialsupport.com)
Krankenhaus Martha-Maria Halle-Dölau gGmbH Halle, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Kurashiki Central Hospital Okayama, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Kyoto University Hospital Kyoto, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Kyushu University Hospital Fukuoka, Boehringer Ingelheim - (nippon@bitrialsupport.com)
LUMPII Doctors practice Riga, Boehringer Ingelheim - (latvia@bitrialsupport.com)
Lady Davis Carmel Medical Center Haifa, Boehringer Ingelheim - (israel@bitrialsupport.com)
Liverpool Heart & Chest Hospital Liverpool, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Lung Research Queensland Chermside, Queensland Boehringer Ingelheim - (australia@bitrialsupport.com)
Lungenfachklinik Immenhausen Immenhausen, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Lungenheilkunde München-Pasing München, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
M. S. Ramaiah Institute of Health Science Bengaluru, Boehringer Ingelheim - (india@bitrialsupport.com)
M2M Med Sp. z o.o. sp. j. Chorzów, Boehringer Ingelheim - (polska@bitrialsupport.com)
MHAT Rahila Angelova AD Pernik, Boehringer Ingelheim - (balgariya@bitrialsupport.com)
Macquarie University North Ryde, New South Wales Boehringer Ingelheim - (australia@bitrialsupport.com)
Manisa Celal Bayar Üniversitesi Tıp Fakültesi Manisa, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Marius Nasta Institute of Pneumophthisiology Bucharest, Boehringer Ingelheim - (romania@bitrialsupport.com)
Marmara University Pendik Training and Research Hospital Istanbul, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Martin-Luther-Universität Halle-Wittenberg Halle, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Massachusetts General Hospital Boston, Massachusetts Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Mater Hospital Brisbane South Brisbane, Queensland Boehringer Ingelheim - (australia@bitrialsupport.com)
Matsue Medical Center Shimane, Matsue, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Matsusaka City Hospital Mie, Matsusaka, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Mautalen- Salud e Investigacion CABA, Boehringer Ingelheim - (argentina@bitrialsupport.com)
Mayo Clinic - Florida Jacksonville, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Mayo Clinic, Rochester Rochester, Minnesota Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Mecas Servicos Educacionais e Administrativos LTDA João Pessoa, Boehringer Ingelheim - (brasil@bitrialsupport.com)
Med.Center OLVI Health Center Assotiation,Private Practice Daugavpils, Boehringer Ingelheim - (latvia@bitrialsupport.com)
MediTrial s.r.o. Jindřichův Hradec, Boehringer Ingelheim - (cesko@bitrialsupport.com)
Mediadvance Clinical S.A.P.I de C.V. Chihuahua City, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Medical Center "Pulmovision" Sofia, Boehringer Ingelheim - (balgariya@bitrialsupport.com)
Medical Center "Sveti Ivan Rilski" Vidin, Boehringer Ingelheim - (balgariya@bitrialsupport.com)
Medical Center K2J2 Wołomin, Boehringer Ingelheim - (polska@bitrialsupport.com)
Medical Center Tara Veliko Tarnovo, Boehringer Ingelheim - (balgariya@bitrialsupport.com)
Medical Center Unimed Plovdiv, Boehringer Ingelheim - (balgariya@bitrialsupport.com)
Medical University of Graz State Hospital - University Hospital Graz Graz, Boehringer Ingelheim - (oesterreich@bitrialsupport.com)
Medical University of Innsbruck Innsbruck, Boehringer Ingelheim - (oesterreich@bitrialsupport.com)
Medical University of South Carolina Charleston, South Carolina Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Medizinische Hochschule hannover Hanover, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Meris Clinical Research-Brandon-69466 Brandon, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Mersin University Research and Training Hospital Chest Diseases Department Yenişehir, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Methodist Heart and Lung Institute San Antonio, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Metroplex Pulmonary & Sleep Center McKinney, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Middlemore Clinical Trials Papatoetoe, Boehringer Ingelheim - (newzealand@bitrialsupport.com)
Midland Healthcare & Research Center Lucknow, Boehringer Ingelheim - (india@bitrialsupport.com)
Minami Kyoto Hospital Kyoto, Joyo, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Momentum Clinical Research Mount Cook, Wellington Region Boehringer Ingelheim - (newzealand@bitrialsupport.com)
Momentum Clinical Research Dunedin Dunedin, Otago Boehringer Ingelheim - (newzealand@bitrialsupport.com)
Momentum clinical Research Tauranga Tauranga, Bay of Plenty Boehringer Ingelheim - (newzealand@bitrialsupport.com)
Multidisciplinary City Hospital №1 of the Akimat of Astana Astana, Boehringer Ingelheim - (kazakhstan@bitrialsupport.com)
NZ Respiratory and Sleep Institute Greenlane East, Auckland Boehringer Ingelheim - (newzealand@bitrialsupport.com)
Nagasaki University Hospital Nagasaki, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Nagoya University Hospital Nagoya, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Nanjing Drum Tower Hospital Nanjing, Boehringer Ingelheim - (china@bitrialsupport.com)
Nanjing First Hospital Nanjing, Boehringer Ingelheim - (china@bitrialsupport.com)
Narayana Health - Mazumdar Shaw Medical Center Bengaluru, Boehringer Ingelheim - (india@bitrialsupport.com)
National Center for Child Health and Development Setagaya-Ku, Tokyo Boehringer Ingelheim - (nippon@bitrialsupport.com)
National Hospital Organization Kinki-Chuo Chest Medical Center Sakai, Boehringer Ingelheim - (nippon@bitrialsupport.com)
National Jewish Health Denver, Colorado Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
National Taiwan University Hospital Taipei, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
National Taiwan University Hospital Yun-Lin Branch Yunlin County, Boehringer Ingelheim - (taiwan@bitrialsupport.com)
National University Hospital-Singapore-42005 Singapore, Boehringer Ingelheim - (singapore@bitrialsupport.com)
Netspiro Clinica Medica Ltda - Respsono São Bernardo do Campo, Boehringer Ingelheim - (brasil@bitrialsupport.com)
New York Medical College - Hawthorne Hawthorne, New York Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
New York University Langone Medical Center New York, New York Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
NewYork-Presbyterian/Weill Cornell Medical Center New York, New York Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Newport Native MD, Inc Newport Beach, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Nihon University Itabashi Hospital Tokyo, Itabashi-ku, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Niigata University Medical and Dental Hospital Niigata, Niigata, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Ninewells Hospital & Medical School Dundee, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Ningbo Medical Center Lihuili Hospital Ningbo, Boehringer Ingelheim - (china@bitrialsupport.com)
Noordwest Ziekenhuisgroep Alkmaar, Boehringer Ingelheim - (nederland@bitrialsupport.com)
North Florida/South Georgia Veterans Health System Gainesville, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Northern General Hospital Sheffield, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Northern Jiangsu People's Hospital Yangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
Northwell Health New Hyde Park, New York Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Northwestern University Chicago, Illinois Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Oaxaca Site Management Organization, S.C. Oaxaca City, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Oita University Hospital Oita, Yufu, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Oregon Health and Sciences University Portland, Oregon Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Osaka Toneyama Medical Center Osaka, Toyonaka, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Osp. Pediatrico Bambin Gesù Roma, Boehringer Ingelheim - (italia@bitrialsupport.com)
Oulun yliopistollinen keskussairaala Oulu, Boehringer Ingelheim - (suomi@bitrialsupport.com)
Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences Rohtak, Boehringer Ingelheim - (india@bitrialsupport.com)
Paradigm Clinical Research - Redding Redding, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Pauls Stradins Clinical University Hospital Riga, Boehringer Ingelheim - (latvia@bitrialsupport.com)
Peking Union Medical College Hospital Beijing, Boehringer Ingelheim - (china@bitrialsupport.com)
Peking University People's Hospital Beijing, Boehringer Ingelheim - (china@bitrialsupport.com)
Peking University Third Hospital Beijing, Boehringer Ingelheim - (china@bitrialsupport.com)
Peninsula Health Frankston, Victoria Boehringer Ingelheim - (australia@bitrialsupport.com)
People's Hospital of Sichuan Province Chengdu, Boehringer Ingelheim - (china@bitrialsupport.com)
Philippine General Hospital Taft, Manila, Boehringer Ingelheim - (pilipinas@bitrialsupport.com)
Pinehurst Medical Clinic, Inc. - East Pinehurst, North Carolina Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
PingXiang People's Hospital Pingxiang, Boehringer Ingelheim - (china@bitrialsupport.com)
Plucna ambulancia Hrebenar s.r.o. Spišská Nová Ves, Boehringer Ingelheim - (slovensko@bitrialsupport.com)
Policlinico "Paolo Giaccone" Palermo, Boehringer Ingelheim - (italia@bitrialsupport.com)
Policlinico S. Orsola-Malpighi Bologna, Boehringer Ingelheim - (italia@bitrialsupport.com)
Premier Medical Associates The Villages, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Prince of Wales Hospital-Hong Kong-20715 Hong Kong, Boehringer Ingelheim - (hongkong@bitrialsupport.com)
ProMedica Physicians Pulmonary and Sleep Medicine - Toledo Toledo, Ohio Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Providence Medical Group Alaska Anchorage, Alaska Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Providence Medical Research Center Spokane, Washington Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Puerto Rico Consortium for Clinical Investigation San Juan, Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
QEII Health Sciences Centre Halifax, Nova Scotia Boehringer Ingelheim - (canada@bitrialsupport.com)
QingDao Municipal Hospital Qingdao, Boehringer Ingelheim - (china@bitrialsupport.com)
Qingpu Branch of Zhongshan Hospital Affiliated to Fudan University Shanghai, Boehringer Ingelheim - (china@bitrialsupport.com)
Queen Mary Hospital Hong Kong, Boehringer Ingelheim - (hongkong@bitrialsupport.com)
Queensland Children's Hospital South Brisbane, Queensland Boehringer Ingelheim - (australia@bitrialsupport.com)
Quirino Memorial Medical Center Quezon City, Boehringer Ingelheim - (pilipinas@bitrialsupport.com)
Rabin Medical Center Beilinson Petah Tikva, Boehringer Ingelheim - (israel@bitrialsupport.com)
Ramathibodi Hospital Bangkok, Boehringer Ingelheim - (thai@bitrialsupport.com)
Republic Klaipeda Hospital Klaipėda, Boehringer Ingelheim - (lithuania@bitrialsupport.com)
Respiratory Medicine Centre, private prac., Bialystok Bialystok, Boehringer Ingelheim - (polska@bitrialsupport.com)
Riga 1st Hospital Riga, Boehringer Ingelheim - (latvia@bitrialsupport.com)
Riga East University Hospital Upeslejas, Boehringer Ingelheim - (latvia@bitrialsupport.com)
Royal Brompton Hospital London, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Royal Hospital for Children and Young People Edinburgh, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Royal Infirmary of Edinburgh Edinburgh, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Royal Lancaster Infirmary Lancaster, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Royal Papworth Hospital Cambridge, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Royal Prince Alfred Hospital Camperdown, Boehringer Ingelheim - (australia@bitrialsupport.com)
Royal Stoke University Hospital Stoke-on-Trent, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Royal University Hospital (Saskatoon) Saskatoon, Saskatchewan Boehringer Ingelheim - (canada@bitrialsupport.com)
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH Essen, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai, Boehringer Ingelheim - (china@bitrialsupport.com)
Rutgers Robert Wood Johnson Medical School New Brunswick, New Jersey Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
SC Medlife S.A Cluj-Napoca, Boehringer Ingelheim - (romania@bitrialsupport.com)
SHATPPD "Dr. Dimitar Gramatikov" Rousse, Boehringer Ingelheim - (balgariya@bitrialsupport.com)
SMG-SNU Boramae Medical Center Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
SSM Health Cardinal Glennon Children's Hospital St Louis, Missouri Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Saga University Hospital Saga, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Saitama Cardiovascular and Respiratory Center Saitama, Kumagaya, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Samsung Medical Center Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
San Juan Bautista School of Medicine Caguas, Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Sarawak General Hospital Kuching, Boehringer Ingelheim - (malaysia@bitrialsupport.com)
Sağlık Bilimleri Üniversitesi Gülhane Eğitim ve Araştırma Hastanesi Ankara, Boehringer Ingelheim - (turkiye@bitrialsupport.com)
Sbalpfz-Vratsa Vratsa, Boehringer Ingelheim - (balgariya@bitrialsupport.com)
Screenmed Sp. z o.o. Piaseczno, Boehringer Ingelheim - (polska@bitrialsupport.com)
Serviços Medicos Respirar Sul Fluminense Barra Mansa, Boehringer Ingelheim - (brasil@bitrialsupport.com)
Severance Hospital Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Shanghai Fifth People's Hospital affiliated to Fudan University Shanghai, Boehringer Ingelheim - (china@bitrialsupport.com)
Shanghai General Hospital Shanghai, Boehringer Ingelheim - (china@bitrialsupport.com)
Shanghai Pulmonary Hospital Shanghai, Boehringer Ingelheim - (china@bitrialsupport.com)
Shengjing Hospital of China Medical University Shenyang, Boehringer Ingelheim - (china@bitrialsupport.com)
Shenzhen People's Hospital Shenzhen, Boehringer Ingelheim - (china@bitrialsupport.com)
Shiga University of Medical Science Hospital Shiga, Otsu, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Siddhi Hospital, C/o Dr. Mutha Hospital Nashik, Boehringer Ingelheim - (india@bitrialsupport.com)
Singapore General Hospital Singapore, Boehringer Ingelheim - (singapore@bitrialsupport.com)
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine Hangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
Siriraj Hospital Bangkok, Boehringer Ingelheim - (thai@bitrialsupport.com)
Soluciones terapeuticas medico quirurgicas S de RL de CV Mexico City, Boehringer Ingelheim - (mexico@bitrialsupport.com)
Songklanagarind Hospital Songkhla, Boehringer Ingelheim - (thai@bitrialsupport.com)
Sourasky Medical Center Tel Aviv, Boehringer Ingelheim - (israel@bitrialsupport.com)
Southampton General Hospital Southampton, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Specialty Hospital Medico Rijeka, Boehringer Ingelheim - (hrvatska@bitrialsupport.com)
Srinagarind Hospital Khon Kaen, Boehringer Ingelheim - (thai@bitrialsupport.com)
St James's University Hospital Leeds, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
St. Francis Medical Institute Clearwater, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
St. Paul's Hospital (Vancouver) Vancouver, British Columbia Boehringer Ingelheim - (canada@bitrialsupport.com)
St. Vincent's University Hospital Dublin, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Stern Research Partners, LLC Huntersville, North Carolina Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Suining Central Hospital Suining, Boehringer Ingelheim - (china@bitrialsupport.com)
Taichung Veterans General Hospital Xitun Dist., Boehringer Ingelheim - (taiwan@bitrialsupport.com)
Tampere University Hospital Tampere, Boehringer Ingelheim - (suomi@bitrialsupport.com)
Tan Tock Seng Hospital Singapore, Boehringer Ingelheim - (singapore@bitrialsupport.com)
Technische Universitat Dresden Dresden, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Tenryu Hospital Shizuoka, Hamamatsu, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Terada Clinic, Respiratory Medicine & General practice Hyogo, Himeji, Boehringer Ingelheim - (nippon@bitrialsupport.com)
The Catholic University of Korea, Eunpyeong St. Mary's Hospital Seoul, Seoul-teukbyeolsi [seoul] Boehringer Ingelheim - (namhan@bitrialsupport.com)
The Catholic University of Korea, Incheon St. Mary's Hospital Bupyeong-gu, Boehringer Ingelheim - (namhan@bitrialsupport.com)
The Catholic University of Korea, Seoul St.Mary's Hospital Seoul, Boehringer Ingelheim - (namhan@bitrialsupport.com)
The Children's Hospital of Fudan University Shanghai, Boehringer Ingelheim - (china@bitrialsupport.com)
The First Affiliated Hospital of Anhui Medical University Hefei, Boehringer Ingelheim - (china@bitrialsupport.com)
The First Affiliated Hospital of NanChang University Nanchang, Boehringer Ingelheim - (china@bitrialsupport.com)
The First Affiliated Hospital of Ningbo University Ningbo, Boehringer Ingelheim - (china@bitrialsupport.com)
The First Affiliated Hospital of Soochow University Suzhou, Jiangsu Boehringer Ingelheim - (china@bitrialsupport.com)
The First Affiliated Hospital of Wenzhou Medical University Wenzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
The First Affiliated Hospital, Zhejiang University Hangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
The First Pulmonary Private Practice Prague, Boehringer Ingelheim - (cesko@bitrialsupport.com)
The Lung Research Center, LLC Chesterfield, Missouri Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
The Prince Charles Hospital Chermside, Queensland Boehringer Ingelheim - (australia@bitrialsupport.com)
The Royal Children's Hospital Parkville, Victoria Boehringer Ingelheim - (australia@bitrialsupport.com)
The Second Affiliated Hospital Zhejiang University School of Medicine Hangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
The Second Affiliated Hospital of Fujian Medical University Quanzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
The Second Affiliated Hospital to Nanchang University Nanchang, Boehringer Ingelheim - (china@bitrialsupport.com)
The Second Hospital of Jilin University Changchun, Boehringer Ingelheim - (china@bitrialsupport.com)
The Second Xiangya Hospital of Central South University Changsha, Boehringer Ingelheim - (china@bitrialsupport.com)
The University of North Carolina at Chapel Hill Chapel Hill, North Carolina Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Thoraxklinik-Heidelberg gGmbH am Universitätsklinikum Heidelberg Heidelberg, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Tianjin Medical University General Hospital Tianjin, Boehringer Ingelheim - (china@bitrialsupport.com)
Tohoku University Hospital Sendai, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Tokushima University Hospital Tokushima, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Tokyo Women's Medical University Hospital Tokyo, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Tongji Hospital, Tongji University Shanghai, Boehringer Ingelheim - (china@bitrialsupport.com)
Toranomon Hospital Tokyo, Minato-ku, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Torbay Hospital Torquay, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Trialswest Spearwood, Western Australia Boehringer Ingelheim - (australia@bitrialsupport.com)
Turku University Hospital / TYKS Turku, Boehringer Ingelheim - (suomi@bitrialsupport.com)
ULS Braga Braga, Boehringer Ingelheim - (portugal@bitrialsupport.com)
ULS da Região de Aveiro Aveiro, Boehringer Ingelheim - (portugal@bitrialsupport.com)
ULS da Região de Leiria, E.P.E. Leiria, Boehringer Ingelheim - (portugal@bitrialsupport.com)
ULS de Gaia/Espinho, EPE Vila Nova de Gaia, Boehringer Ingelheim - (portugal@bitrialsupport.com)
ULS de Santa Maria, E.P.E Lisbon, Boehringer Ingelheim - (portugal@bitrialsupport.com)
ULS de São João Porto, Boehringer Ingelheim - (portugal@bitrialsupport.com)
ULS do Alto Ave Guimarães, Boehringer Ingelheim - (portugal@bitrialsupport.com)
UMC Utrecht Utrecht, Boehringer Ingelheim - (nederland@bitrialsupport.com)
UMass Memorial Medical Center Worcester, Massachusetts Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
UZ Leuven Leuven, Boehringer Ingelheim - (belgique@bitrialsupport.com)
Ulsan University Hospital Ulsan, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Univ. Hospital Martin Martin, Boehringer Ingelheim - (slovensko@bitrialsupport.com)
Universitair Ziekenhuis Gent Ghent, Oost-Vlaanderen Boehringer Ingelheim - (belgique@bitrialsupport.com)
Universitatsklinikum Freiburg Freiburg im Breisgau, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitatsklinikum Jena Jena, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitatsklinikum Schleswig-Holstein, Campus Kiel Kiel, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitetssjukhuset, Örebro Örebro, Boehringer Ingelheim - (sverige@bitrialsupport.com)
University Hospital Hairmyres East Kilbride, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
University Hospital Llandough Cardiff, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
University Hospital Motol Prague, Boehringer Ingelheim - (cesko@bitrialsupport.com)
University Hospital of Lausanne Lausanne, Boehringer Ingelheim - (suisse@bitrialsupport.com)
University Hospitals of Cleveland Cleveland, Ohio Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Alabama at Birmingham Birmingham, Alabama Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Arizona Tucson, Arizona Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Calgary Calgary, Alberta Boehringer Ingelheim - (canada@bitrialsupport.com)
University of California Davis Sacramento, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Cincinnati Cincinnati, Ohio Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Florida College of Medicine Jacksonville, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Iowa Hospitals and Clinics Iowa City, Iowa Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Kansas Medical Center Kansas City, Kansas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Malaya Medical Centre Kuala Lumpur, Boehringer Ingelheim - (malaysia@bitrialsupport.com)
University of Maryland St. Joseph Medical Group Pulmonary Care and Sleep Medicine Towson, Maryland Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Miami Miami, Florida Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Michigan Health System Ann Arbor, Michigan Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Mississippi Medical Center Jackson, Mississippi Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Nebraska Medical Center Omaha, Nebraska Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Pennsylvania Philadelphia, Pennsylvania Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Texas Health Science Center at San Antonio San Antonio, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Texas Health Science Center at Tyler Tyler, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Texas Medical Branch at Galveston Galveston, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Texas Southwestern Medical Center Dallas, Texas Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Tsukuba Hospital Tsukuba, Boehringer Ingelheim - (nippon@bitrialsupport.com)
University of Vermont Burlington, Vermont Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Washington Seattle, Washington Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
University of Wisconsin Madison, Wisconsin Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Universitätsklinikum Aachen, AöR Aachen, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitätsklinikum Bonn AöR Bonn, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitätsklinikum Frankfurt Frankfurt, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitätsklinikum Köln (AöR) Cologne, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitätsklinikum Münster Münster, North Rhine-Westphalia Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitätsmedizin der Johannes Gutenberg-Universität Mainz Mainz, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Universitätsspital Basel Basel, Boehringer Ingelheim - (suisse@bitrialsupport.com)
VA Caribbean Healthcare System San Juan, Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
VCA Dubultu Medical center Jūrmala, Boehringer Ingelheim - (latvia@bitrialsupport.com)
Vejle University Hospital Vejle, Boehringer Ingelheim - (danmark@bitrialsupport.com)
Velocity Clinical Research Germany GmbH, Ahrensburg Ahrensburg, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Velocity Clinical Research Germany GmbH, Lübeck Lübeck, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Velocity Clinical Research, Bristol Bristol, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Ventura County Medical Center Ventura, California Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Vilnius University Hospital, Santariskiu Vilnius, Boehringer Ingelheim - (lithuania@bitrialsupport.com)
Virginia Commonwealth University Health Systems Richmond, Virginia Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Vitaz - Campus Sint-Niklaas Sint-Niklaas, Boehringer Ingelheim - (belgique@bitrialsupport.com)
Vivantes Netzwerk für Gesundheit GmbH Berlin, Boehringer Ingelheim - (deutschland@bitrialsupport.com)
Waikato Hospital Hamilton, Waikato Region Boehringer Ingelheim - (newzealand@bitrialsupport.com)
Washington University School of Medicine St Louis, Missouri Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Washington University School of Medicine St Louis, Missouri Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Wenzhou People's Hospital Wenzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
West China Hospital of Sichuan University Chengdu, Boehringer Ingelheim - (china@bitrialsupport.com)
West Visayas State University Medical Center Iloilo City, Boehringer Ingelheim - (pilipinas@bitrialsupport.com)
Western General Hospital Edinburgh, Boehringer Ingelheim - (unitedkingdom@bitrialsupport.com)
Westmead Hospital Westmead, New South Wales Boehringer Ingelheim - (australia@bitrialsupport.com)
Wuhan Union Hospital Wuhan, Boehringer Ingelheim - (china@bitrialsupport.com)
Wuxi People's Hospital Wuxi, Jiangsu Boehringer Ingelheim - (china@bitrialsupport.com)
Yale University School of Medicine New Haven, Connecticut Boehringer Ingelheim - (unitedstates@bitrialsupport.com)
Yamaguchi University Hospital Ube, Boehringer Ingelheim - (nippon@bitrialsupport.com)
Yeongnam University Hospital Daegu, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Yixing People'S Hospital Yixing, Boehringer Ingelheim - (china@bitrialsupport.com)
Yonsei University Wonju Severance Christian Hospital Wŏnju, Boehringer Ingelheim - (namhan@bitrialsupport.com)
Zeleznicna Hospital Kosice Košice, Boehringer Ingelheim - (slovensko@bitrialsupport.com)
Zhejiang Hospital Hangzhou, Boehringer Ingelheim - (china@bitrialsupport.com)
Zhongshan Hospital Affiliated to Fudan University Shanghai, Boehringer Ingelheim - (china@bitrialsupport.com)
the First Hospital of Jilin University Changchun, Boehringer Ingelheim - (china@bitrialsupport.com)

Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial

ctrrecruit@vcu.edu

NCT05564377
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Inclusion Criteria:
* Patient must have measurable disease * Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status between 0-2 OR patient must have Lansky performance status of \>= 50% or Karnofsky performance status of \>= 50% * Patient must be deemed potentially eligible for a ComboMATCH Treatment Trial as assessed by the enrolling provider * All patients must have sequencing results available from a National Cancer Institute (NCI) credentialed Designated Laboratory (DL) * Patients must have locally advanced or advanced histologically documented solid tumors requiring therapy and meet one of the following criteria: * Patients must have progressed on at least one line of standard systemic therapy OR * Patients whose disease has no standard treatment that has been shown to prolong overall survival * Patient must meet one of the following requirements: * Patients 18 years and older who have tumor amenable to minimal risk image-guided or direct vision biopsy and must be willing and able to undergo a tumor biopsy to obtain samples for research if the patient is to enroll in a ComboMATCH treatment trial OR * Patients 18 years and older who do not have disease that is biopsiable at minimal risk to the patient must confirm availability of an archival tumor tissue specimen for submission for research if the patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria: * Tissue must have been collected within 12 months prior to registration to the EAY191 Registration Trial * Patient must not have had a Response Evaluation Criteria in Solid Tumors (RECIST) response (complete response \[CR\] or partial response \[PR\]) to any intervening therapy after collection of the tissue * Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available OR * Patients under 18 years old must confirm availability of an archival tumor tissue specimen for submission for research if patient enrolls to a ComboMATCH Treatment Trial. This tumor tissue must meet the following criteria: * Formalin-fixed paraffin-embedded tumor tissue block(s) or slides must be available * NOTE: See specific ComboMATCH Treatment Trial protocol for tissue collection and management instructions. Performance of the mandatory research biopsy or submission of pre-trial formalin-fixed paraffin-embedded (FFPE) and collection and submission of the blood specimens for the integrated studies will be performed under the consent authority of the specific treatment trial protocol to which the patient is registered. No procedures to collect specimens for research only are to be performed for patients registered to the EAY191 Registration Trial only * NOTE: Each ComboMATCH Treatment Trial contains specific eligibility criteria. If patient is found to not be eligible for the assigned ComboMATCH Treatment Trial, indication of ineligibility will trigger re-evaluation and potential assignment to another Treatment Trial
DRUG: Alpelisib, DRUG: Binimetinib, PROCEDURE: Biopsy Procedure, PROCEDURE: Biospecimen Collection, PROCEDURE: Bone Marrow Aspiration, PROCEDURE: Bone Marrow Biopsy, PROCEDURE: Bone Scan, PROCEDURE: Computed Tomography, PROCEDURE: Echocardiography Test, DRUG: Fluorouracil, DRUG: Fulvestrant, DRUG: Ipatasertib, DRUG: Leucovorin, PROCEDURE: Magnetic Resonance Imaging, PROCEDURE: Multigated Acquisition Scan, PROCEDURE: Mutation Carrier Screening, DRUG: Neratinib Maleate, DRUG: Nilotinib Hydrochloride Monohydrate, DRUG: Olaparib, DRUG: Oxaliplatin, DRUG: Paclitaxel, DRUG: Palbociclib, BIOLOGICAL: Panitumumab, PROCEDURE: Positron Emission Tomography, DRUG: Selumetinib Sulfate, DRUG: Sotorasib
Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Locally Advanced Malignant Solid Neoplasm, Malignant Female Reproductive System Neoplasm, Metastatic HER2-Negative Breast Carcinoma, Metastatic Malignant Solid Neoplasm, Recurrent Endometrial Carcinoma, Recurrent Fallopian Tube Carcinoma, Recurrent Malignant Female Reproductive System Neoplasm, Recurrent Malignant Solid Neoplasm, Recurrent Ovarian Carcinoma, Recurrent Primary Peritoneal Carcinoma, Unresectable HER2-Negative Breast Carcinoma, Unresectable Malignant Solid Neoplasm
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AMG Crystal Lake - Oncology Crystal Lake, Illinois Site Public Contact - (advocateresearch@advocate.com)
AMG Libertyville - Oncology Libertyville, Illinois Site Public Contact - (advocateresearch@advocatehealth.com)
Abbott-Northwestern Hospital Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Adena Regional Medical Center Chillicothe, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Advocate Christ Medical Center Oak Lawn, Illinois
Advocate Good Samaritan Hospital Downers Grove, Illinois Site Public Contact - (Barbara.barhamand@advocatehealth.com)
Advocate Good Shepherd Hospital Barrington, Illinois
Advocate Illinois Masonic Medical Center Chicago, Illinois
Advocate Lutheran General Hospital Park Ridge, Illinois
Advocate Sherman Hospital Elgin, Illinois
Advocate South Suburban Hospital Hazel Crest, Illinois
Alaska Women's Cancer Care Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Alliance for Childhood Diseases/Cure 4 the Kids Foundation Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Armes Family Cancer Center Findlay, Ohio
Asplundh Cancer Pavilion Willow Grove, Pennsylvania Site Public Contact - (ONCTrialNow@jefferson.edu)
Atrium Medical Center-Middletown Regional Hospital Franklin, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Aultman Health Foundation Canton, Ohio Site Public Contact - (ClinicalReserachDept@aultman.com)
Aurora Bay Area Medical Group-Marinette Marinette, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora BayCare Medical Center Green Bay, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Grafton Grafton, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Kenosha South Kenosha, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Milwaukee Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Milwaukee West Wauwatosa, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Racine Racine, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Cancer Care-Southern Lakes VLCC Burlington, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Health Care Germantown Health Center Germantown, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Medical Center in Summit Summit, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Saint Luke's Medical Center Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora Sinai Medical Center Milwaukee, Wisconsin Site Public Contact - (ncorp@aurora.org)
Aurora West Allis Medical Center West Allis, Wisconsin Site Public Contact - (ncorp@aurora.org)
BI-LO Charities Children's Cancer Center Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri
Baptist Cancer Center-Grenada Grenada, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Collierville Collierville, Tennessee Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Desoto Southhaven, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Golden Triangle Columbus, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Memphis Memphis, Tennessee Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Oxford Oxford, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baptist Memorial Hospital and Cancer Center-Union County New Albany, Mississippi Site Public Contact - (BCCclintrials@bmhcc.org)
Baystate Medical Center Springfield, Massachusetts Site Public Contact - (tamara.wrenn@baystatehealth.org)
Beacon Kalamazoo Kalamazoo, Michigan
Beacon Kalamazoo Cancer Center Kalamazoo, Michigan
Benefis Sletten Cancer Institute Great Falls, Montana Site Public Contact - (mccinfo@mtcancer.org)
Beth Israel Deaconess Medical Center Boston, Massachusetts
Billings Clinic Cancer Center Billings, Montana Site Public Contact - (research@billingsclinic.org)
Bozeman Health Deaconess Hospital Bozeman, Montana Site Public Contact - (mccinfo@mtcancer.org)
Bronson Battle Creek Battle Creek, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Bronson Methodist Hospital Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Broward Health Medical Center Fort Lauderdale, Florida Site Public Contact - (Allison.bruce@nemours.org)
Bryn Mawr Hospital Bryn Mawr, Pennsylvania Site Public Contact - (turzoe@mlhs.org)
CTCA at Southeastern Regional Medical Center Newnan, Georgia
CTCA at Western Regional Medical Center Goodyear, Arizona
Cancer Care Center of O'Fallon O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Care Specialists of Illinois - Decatur Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Care and Hematology-Fort Collins Fort Collins, Colorado Site Public Contact - (ecog.rss@jimmy.harvard.edu)
Cancer Hematology Centers - Flint Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan Site Public Contact - (connie.szczepanek@crcwm.org)
Capital Health Medical Center-Hopewell Pennington, New Jersey
Carilion Roanoke Memorial Hospital Roanoke, Virginia
Carle Cancer Center Urbana, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Effingham Effingham, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Mattoon/Charleston Mattoon, Illinois Site Public Contact - (Research@carle.com)
Carle at The Riverfront Danville, Illinois Site Public Contact - (Research@Carle.com)
Case Western Reserve University Cleveland, Ohio Site Public Contact - (CTUReferral@UHhospitals.org)
Cedars Sinai Medical Center Los Angeles, California
Centralia Oncology Clinic Centralia, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Centro Comprensivo de Cancer de UPR San Juan, Site Public Contact - (ecog.rss@jimmy.harvard.edu)
Chelsea Hospital Chelsea, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Children's Hospital of Orange County Orange, California Site Public Contact - (oncresearch@choc.org)
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio
Cleveland Clinic Cancer Center/Fairview Hospital Cleveland, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Cleveland Clinic Foundation Cleveland, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Columbus Oncology and Hematology Associates Dublin, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Columbus Oncology and Hematology Associates Inc Columbus, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Community Hospital of Anaconda Anaconda, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Missoula, Montana Site Public Contact - (mccinfo@mtcancer.org)
Community Medical Center Missoula, Montana Site Public Contact - (Lennette.Gonzales@rwjbh.org)
Condell Memorial Hospital Libertyville, Illinois Site Public Contact - (advocateresearch@advocatehealth.com)
Contra Costa Regional Medical Center Martinez, California
Corewell Health Beaumont Troy Hospital Troy, Michigan
Corewell Health Children's Royal Oak, Michigan
Corewell Health Dearborn Hospital Dearborn, Michigan
Corewell Health Farmington Hills Hospital Farmington Hills, Michigan
Corewell Health Grand Rapids Hospitals - Butterworth Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan
Corewell Health Lakeland Hospitals - Saint Joseph Hospital Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Reed City Hospital Reed City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health William Beaumont University Hospital Royal Oak, Michigan
Covenant Medical Center-Lakeside Lubbock, Texas
Crossroads Cancer Center Effingham, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Dana-Farber Cancer Institute Boston, Massachusetts
Dayton Physician LLC - Englewood Dayton, Ohio
Dayton Physicians LLC-Atrium Franklin, Ohio
Decatur Memorial Hospital Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Delaware Health Center-Grady Cancer Center Delaware, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Doctors Cancer Center Manatí,
Doctors Hospital Columbus, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Dublin Methodist Hospital Dublin, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Duke University Medical Center Durham, North Carolina
Duke Women's Cancer Care Raleigh Raleigh, North Carolina
Duluth Clinic Ashland Ashland, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
East Jefferson General Hospital Metairie, Louisiana Site Public Contact - (emede1@lsuhsc.edu)
Edwards Comprehensive Cancer Center Huntington, West Virginia Site Public Contact - (Christina.Cole@chhi.org)
Epic Care Cyberknife Center Walnut Creek, California
Epic Care-Dublin Dublin, California
Essentia Health - Deer River Clinic Deer River, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Cancer Center Duluth, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Hibbing Clinic Hibbing, Minnesota
Essentia Health Sandstone Sandstone, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Virginia Clinic Virginia, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Fairfield Medical Center Lancaster, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fairview Southdale Hospital Edina, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fox Chase Cancer Center Philadelphia, Pennsylvania
Genesee Hematology Oncology PC Flint, Michigan
Genesis Healthcare System Cancer Care Center Zanesville, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Genesys Hurley Cancer Institute Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Good Samaritan Hospital - Cincinnati Cincinnati, Ohio Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Grady Memorial Hospital Delaware, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Grant Medical Center Columbus, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Greater Dayton Cancer Center Kettering, Ohio
Gulfport Memorial Hospital Gulfport, Mississippi Site Public Contact - (emede1@lsuhsc.edu)
Gundersen Lutheran Medical Center La Crosse, Wisconsin Site Public Contact - (cancerctr@gundersenhealth.org)
Guthrie Medical Group PC-Robert Packer Hospital Sayre, Pennsylvania
Harold Alfond Center for Cancer Care Augusta, Maine
Hawaii Cancer Care - Westridge ‘Aiea, Hawaii Site Public Contact - (info@hawaiicancercare.com)
Hawaii Cancer Care Inc - Waterfront Plaza Honolulu, Hawaii Site Public Contact - (i.webster@hawaiicancercare.com)
Hayworth Cancer Center High Point, North Carolina
Heartland Regional Medical Center Saint Joseph, Missouri Site Public Contact - (Trisha.England2@mymlc.com)
Helen F Graham Cancer Center Newark, Delaware Site Public Contact - (lbarone@christianacare.org)
Hendrick Medical Center Abilene, Texas
Henry Ford Saint John Hospital - Macomb Medical Macomb, Michigan Site Public Contact - (kforman1@hfhs.org)
Hillcrest Hospital Cancer Center Mayfield Heights, Ohio Site Public Contact - (TaussigResearch@ccf.org)
Houston Methodist Hospital Houston, Texas
Houston Methodist Saint John Hospital Nassau Bay, Texas
Houston Methodist Sugar Land Hospital Sugar Land, Texas
Houston Methodist The Woodlands Hospital The Woodlands, Texas
Houston Methodist West Hospital Houston, Texas
Hunterdon Medical Center Flemington, New Jersey
Hurley Medical Center Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Huron Gastroenterology PC Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Illinois CancerCare - Washington Washington, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Bloomington Bloomington, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Canton Canton, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Carthage Carthage, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Dixon Dixon, Illinois
Illinois CancerCare-Eureka Eureka, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Galesburg Galesburg, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Kewanee Clinic Kewanee, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Macomb Macomb, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Ottawa Clinic Ottawa, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Pekin Pekin, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Peoria Peoria, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Peru Peru, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Princeton Princeton, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Ingalls Memorial Hospital Harvey, Illinois Site Public Contact - (clinicaltrials@ingalls.org)
Inova Fairfax Hospital Falls Church, Virginia Site Public Contact - (Stephanie.VanBebber@inova.org)
Inova Schar Cancer Institute Fairfax, Virginia Site Public Contact - (Stephanie.VanBebber@inova.org)
John H Stroger Jr Hospital of Cook County Chicago, Illinois
Kapiolani Medical Center for Women and Children Honolulu, Hawaii
Kettering Medical Center Kettering, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Kingman Regional Medical Center Kingman, Arizona Site Public Contact - (research@sncrf.org)
Knox Community Hospital Mount Vernon, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Kootenai Clinic Cancer Services - Post Falls Post Falls, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Clinic Cancer Services - Sandpoint Sandpoint, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Kootenai Health - Coeur d'Alene Coeur d'Alene, Idaho Site Public Contact - (mccinfo@mtcancer.org)
Lafayette Family Cancer Center-EMMC Brewer, Maine
Lankenau Medical Center Wynnewood, Pennsylvania Site Public Contact - (turzoe@mlhs.org)
Laura and Isaac Perlmutter Cancer Center at NYU Langone New York, New York Site Public Contact - (CancerTrials@nyulangone.org)
Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Lehigh Valley Hospital-Hazleton Hazleton, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Licking Memorial Hospital Newark, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Logan Health Medical Center Kalispell, Montana Site Public Contact - (mccinfo@mtcancer.org)
Loyola University Medical Center Maywood, Illinois
Lyndon Baines Johnson General Hospital Houston, Texas
M D Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
MaineHealth Cancer Care and IV Therapy - South Portland South Portland, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
MaineHealth Maine Medical Center- Scarborough Scarborough, Maine Site Public Contact - (clinicalresearch@mainehealth.org)
Marshfield Medical Center - Minocqua Minocqua, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center - Weston Weston, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Mayo Clinic Hospital in Arizona Phoenix, Arizona
Mayo Clinic in Florida Jacksonville, Florida
Mayo Clinic in Rochester Rochester, Minnesota
Medical Center of the Rockies Loveland, Colorado
Medical Oncology Hematology Consultants PA Newark, Delaware Site Public Contact - (lbarone@christianacare.org)
Memorial Hospital Chattanooga, Tennessee Site Public Contact - (Jeffh@columbusccop.org)
Memorial Hospital East Shiloh, Illinois Site Public Contact - (dschwab@wustl.edu)
Memorial Hospital of South Bend South Bend, Indiana
Memorial Sloan Kettering Cancer Center New York, New York
Memorial Sloan Kettering Commack Commack, New York
Memorial Sloan Kettering Monmouth Middletown, New Jersey
Memorial Sloan Kettering Westchester Harrison, New York
Mercy Cancer Center - Carmichael Carmichael, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Cancer Center - Elk Grove Elk Grove, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Cancer Center - Rocklin Rocklin, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Cancer Center - Sacramento Sacramento, California Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Mercy Health - Paducah Cancer Center Paducah, Kentucky
Mercy Health - Perrysburg Hospital Perrysburg, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mercy Health - Saint Anne Hospital Toledo, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mercy Hospital Cedar Rapids, Iowa
Mercy Hospital Cedar Rapids, Iowa Site Public Contact - (mmcorc@healthpartners.com)
Mercy Hospital Saint Louis St Louis, Missouri
Mercy Hospital South St Louis, Missouri Site Public Contact - (Danielle.Werle@mercy.net)
Mercy Hospital Springfield Springfield, Missouri
Mercy Medical Center - Des Moines Des Moines, Iowa Site Public Contact - (cancerresearch@mercydesmoines.org)
Mercy San Juan Medical Center Carmichael, California Site Public Contact - (OncologyResearch@DignityHealth.org)
Mercyhealth Cancer Institute - Rockford Rockford, Illinois Site Public Contact - (oncologyclinicaltrials@mhemail.org)
Mercyhealth Hospital and Cancer Center - Janesville Janesville, Wisconsin Site Public Contact - (oncologyclinicaltrials@mhemail.org)
Methodist Willowbrook Hospital Houston, Texas
Miami Valley Cancer Care and Infusion Greenville, Ohio
Miami Valley Hospital Dayton, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Miami Valley Hospital North Dayton, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Miami Valley Hospital South Centerville, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Michigan Healthcare Professionals Pontiac Pontiac, Michigan Site Public Contact - (Emily.Crofts@trinity-health.org)
Midwestern Regional Medical Center Zion, Illinois
Missouri Baptist Medical Center St Louis, Missouri
Missouri Baptist Sullivan Hospital Sullivan, Missouri
Monmouth Medical Center Long Branch, New Jersey Site Public Contact - (mary.danish@rwjbh.org)
Monmouth Medical Center Southern Campus Lakewood, New Jersey Site Public Contact - (mary.danish@rwjbh.org)
Montefiore Medical Center - Moses Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Montefiore Medical Center-Einstein Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Montefiore Medical Center-Weiler Hospital The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Mount Carmel East Hospital Columbus, Ohio Site Public Contact - (Jeffh@columbusccop.org)
Mount Sinai Hospital New York, New York Site Public Contact - (CCTO@mssm.edu)
Mount Sinai Hospital Medical Center Chicago, Illinois Site Public Contact - (suhi@sinai.org)
Munson Medical Center Traverse City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
MyMichigan Medical Center Saginaw Saginaw, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
MyMichigan Medical Center Tawas Tawas City, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
NEA Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro Jonesboro, Arkansas Site Public Contact - (Emily.Carvell@bmhcc.org)
NYU Langone Hospital - Long Island Mineola, New York Site Public Contact - (cancertrials@nyulangone.org)
National Institutes of Health Clinical Center Bethesda, Maryland
Nebraska Medicine-Bellevue Bellevue, Nebraska
Nebraska Medicine-Village Pointe Omaha, Nebraska
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital Yakima, Washington Site Public Contact - (Memorial-ClinicalTrials@yvmh.org)
NorthShore University HealthSystem-Evanston Hospital Evanston, Illinois
NorthShore University HealthSystem-Glenbrook Hospital Glenview, Illinois
NorthShore University HealthSystem-Highland Park Hospital Highland Park, Illinois
Northwestern Medicine Cancer Center Delnor Geneva, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Cancer Center Kishwaukee DeKalb, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Cancer Center Warrenville Warrenville, Illinois Site Public Contact - (Donald.Smith3@nm.org)
Northwestern Medicine Glenview Outpatient Center Glenview, Illinois
Northwestern Medicine Grayslake Outpatient Center Grayslake, Illinois
Northwestern Medicine Lake Forest Hospital Lake Forest, Illinois Site Public Contact - (cancertrials@northwestern.edu)
Northwestern Medicine Orland Park Orland Park, Illinois Site Public Contact - (nctnprogram_rhlccc@northwestern.edu)
Northwestern University Chicago, Illinois Site Public Contact - (cancer@northwestern.edu)
OSF Saint Francis Hospital and Medical Group Escanaba, Michigan Site Public Contact - (WI_research_admin@hshs.org)
Ochsner Medical Center Jefferson New Orleans, Louisiana Site Public Contact - (Elisemarie.curry@ochsner.org)
Ohio State University Comprehensive Cancer Center Columbus, Ohio Site Public Contact - (Jamesline@osumc.edu)
OhioHealth Mansfield Hospital Mansfield, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
OhioHealth Marion General Hospital Marion, Ohio Site Public Contact - (Jennifer.Sexton@ohiohealth.com)
Oncology Associates at Mercy Medical Center Cedar Rapids, Iowa
Oncology Hematology Associates of Saginaw Valley PC Saginaw, Michigan
OptumCare Cancer Care at Charleston Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at Fort Apache Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
OptumCare Cancer Care at Seven Hills Henderson, Nevada Site Public Contact - (research@sncrf.org)
Oregon Health and Science University Portland, Oregon Site Public Contact - (trials@ohsu.edu)
PCR Oncology Arroyo Grande, California Site Public Contact - (research@sncrf.org)
PROncology San Juan, Site Public Contact - (info@PRoncology.com)
Pali Momi Medical Center ‘Aiea, Hawaii
Paoli Memorial Hospital Paoli, Pennsylvania Site Public Contact - (turzoe@mlhs.org)
Park Nicollet Clinic - Saint Louis Park Saint Louis Park, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Parkland Health Center - Farmington Farmington, Missouri
Pennsylvania Hospital Philadelphia, Pennsylvania Site Public Contact - (PennCancerTrials@careboxhealth.com)
Phelps Health Delbert Day Cancer Institute Rolla, Missouri Site Public Contact - (research@phelpshealth.org)
Pluta Cancer Center Rochester, New York Site Public Contact - (ecog.rss@jimmy.harvard.edu)
Pocono Medical Center East Stroudsburg, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Poudre Valley Hospital Fort Collins, Colorado
Premier Blood and Cancer Center Dayton, Ohio
Presbyterian Intercommunity Hospital Whittier, California
Prisma Health Cancer Institute - Butternut Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Easley Easley, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Eastside Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Faris Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Greer Greer, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
Prisma Health Cancer Institute - Seneca Seneca, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
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Southern Illinois University School of Medicine Springfield, Illinois
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Springfield Clinic Springfield, Illinois
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Stanford Cancer Institute Palo Alto Palo Alto, California Site Public Contact - (ccto-office@stanford.edu)
State University of New York Upstate Medical University Syracuse, New York
Straub Clinic and Hospital Honolulu, Hawaii
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Summerlin Hospital Medical Center Las Vegas, Nevada Site Public Contact - (research@sncrf.org)
Swedish Cancer Institute-Edmonds Edmonds, Washington Site Public Contact - (PCRC-NCORP@Swedish.org)
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The Mark H Zangmeister Center Columbus, Ohio Site Public Contact - (Jeffh@columbusccop.org)
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Phase 2/3 Adaptive Study of VX-147 in Adult and Pediatric Participants With APOL1- Mediated Proteinuric Kidney Disease (AMPLITUDE)

Medical Information - medicalinfo@vrtx.com

NCT05312879
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Key
Inclusion Criteria:
* APOL1 genotype of G1/G1, G2/G2, or G1/G2 * Proteinuric kidney disease Key
Exclusion Criteria:
* Solid organ or bone marrow transplant * Uncontrolled hypertension * History of diabetes mellitus * Known underlying cause of kidney disease including but not limited to sickle cell disease Other protocol defined Inclusion/Exclusion criteria apply.
DRUG: VX-147, DRUG: Placebo
Proteinuric Kidney Disease
APOL1-mediated kidney disease (AMKD)
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Study Locations

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Location Contacts
A. Alfred Taubman Health Care Center - Nephrology Clinic at Taubman Center Ann Arbor, Michigan
AA Medical Research Center Flint, Michigan
AMR-Miami Coral Gables, Florida
AURA Nord Saint-Ouen,
Advanced Clinical Research of Atlanta Atlanta, Georgia
Alabama Kidney Research Alabaster, Alabama
Ambroise Paré Hospital Paris,
American Clinical Trials LLC - Acworth Acworth, Georgia
American Clinical Trials LLC - Douglasville Douglasville, Georgia
Amicis Research Center - Balboa Granada Hills, California
Amsterdam UMC - Amsterdam Public Health Research Institute Amsterdam,
Ann & Robert H. Lurie Children's Hospital of Chicago - Nephrology Chicago, Illinois
Arizona Kidney Disease and Hypertension Center - Banner Desert Office Mesa, Arizona
Arizona Kidney Disease and Hypertension Center - Thomas Office Phoenix, Arizona
Arlington Nephrology Arlington, Texas
Atlanta VA Healthcare System Decatur, Georgia
Augusta University Medical College of Georgia - Adult Sickle Cell Clinic Augusta, Georgia
Barnes-Jewish Center for Outpatient Health St Louis, Missouri
Barnum Medical Research - Bienville St Natchitoches, Louisiana
Bay Pines Foundation Bay Pines, Florida
Baylor Scott and White Research Institute - Nephrology Dallas, Texas
Beth Israel Deaconess Medical Center - Nephrology Boston, Massachusetts
Bicetre Hospital Le Kremlin-Bicêtre,
Bioluminux Clinical Research New Jersey Hamilton, New Jersey
Boston Medical Center Boston, Massachusetts
Brookview Hills Research Associates Winston-Salem, North Carolina
CHI St. Vincent Heart Clinic Arkansas- Cardiology and Medicine Clinic - Little Rock Little Rock, Arkansas
CHU Dupuytren 2 - Néphrologie, dialyse, transplantations Limoges,
CHU de Guadeloupe Pointe à Pitre,
CNS Healthcare - Memphis Memphis, Tennessee
CSB Group of Nephrology Brazil Salvador,
CTR Oakwater, LLC Orlando, Florida
CUH - Sheridan Pavilion - Three Cooper Plaza Camden, New Jersey
Cardiology, P.C. Birmingham, Alabama
Carolina Nephrology, PA Spartanburg, South Carolina
Cedars-Sinai Medical Center Los Angeles, California
Center for Advanced Kidney Research Saint Clair Shores, Michigan
Center for Specialized Medicine - Nephrology St Louis, Missouri
Centro Cardiovascular Aristides Sotomayor Santa Lucía SAS IPS Cartagena,
Centro de Pesquisa Clinica Professor Salomao Kelner Recife,
Centro de Pesquisa Clinica do Coracao Aracaju,
Children's Hospital of Alabama Birmingham, Alabama
Children's Hospital of Pittsburgh - Nephrology Pittsburgh, Pennsylvania
Children's National Hospital - Nephrology Washington D.C., District of Columbia
Cincinnati VA Medical Center Cincinnati, Ohio
Cleveland Clinic - Main Campus Cleveland, Ohio
Clincept - Veterans Pkwy. Columbus, Georgia
Clindove Research LLC Brooklyn, New York
Clinica de La Costa S.A.S Atlántico,
Clinical & Translational Science Unit (CTSU) - Nephrology Kansas City, Kansas
Clinical Research Strategies - Romano North Main Office Houston, Texas
Clinical Research of Brandon, LLC Brandon, Florida
Cmip-Centro Mineiro de Pesquisa Ltda Juiz de Fora,
Coastal Medical Research Brunswick, Georgia
Columbia Nephrology Associates, PA Columbia, South Carolina
Comlexo Hospitalar Universitário Professor Edgard Santos Salvador,
Cook Children's Medical Center Fort Worth, Texas
Cordova Research Institute Miami, Florida
DaVita Kidney Care - Las Vegas Las Vegas, Nevada
Dallas Nephrology Associates - Dallas Landry Office Dallas, Texas
Dallas Renal Group - Liberty Dallas Dialysis Center Dallas, Texas
Dallas Renal Group - Mansfield Arlington, Texas
Dallas Renal Group- Dallas Dallas, Texas
Davita Clinical Research - El Paso El Paso, Texas
Delray Physician Care Center Delray Beach, Florida
Dom Vicente Scherer Hospital Porto Alegre,
Duke University Hospital - Children's Health Center Durham, North Carolina
Eastern Nephrology Associates - Greenville Office Greenville, North Carolina
Eastern Nephrology Associates - Jacksonville Office Jacksonville, North Carolina
Eastern Nephrology Associates - Kinston Office Kinston, North Carolina
Eastern Nephrology Associates - New Bern Office New Bern, North Carolina
Eastern Nephrology Associates - Wilmington Office Wilmington, North Carolina
Eastside Clinical Research Associates Los Angeles, California
Edward Hines Jr VA Hospital Hines, Illinois
Elixia Pines Hollywood, Florida
Elixia Tampa Tampa, Florida
EmVenio Research - Chicago Chicago, Illinois
EmVenio Research - Mobile Unit - Birmingham Birmingham, Alabama
Emory Childrens Center - Nephrology Atlanta, Georgia
Emory School of Medicine - Renal Division Atlanta, Georgia
Epsom and St Helier University Hospitals NHS Trust Carshalton,
Essential Concepts Research Solutions Palos Hills, Illinois
FDI Clinical Research San Juan,
Faculdade de Medicina de Botucatu - CKD and Hypertension Department Botucatu,
Faculdade de Medicina de Botucatu - Kidney Transplantation Department Botucatu,
Federal University of Goiás (UFG) Goiânia,
Fides Clinical Research Atlanta, Georgia
Frenova-Southwest Houston Houston, Texas
Fundacion Hospitalaria San Vicente de Paul Medellín,
Fundación Valle Del Lili Cali,
Fundação Faculdade Regional de Medicina de São José do Rio Preto São José do Rio Preto,
FutureMeds Birmingham Birmingham,
G.V. (Sonny) Montgomery VAMC Jackson, Mississippi
GCM Medical Group, PSC San Juan,
Galileo Medical Research Ltda Juiz de Fora,
General Nephrology Clinic - New York City New York, New York
Genesis Clinical Research Tampa, Florida
Georgia Nephrology - Decatur Decatur, Georgia
Georgia Nephrology - Lawrenceville - Billing Office Lawrenceville, Georgia
Great Ormond Street Hospital For Children London,
Greater Hartford Nephrology Bloomfield, Connecticut
Grossman School of Medicine New York, New York
Guy's Hospital - Endocrinology London,
Hackensack University Medical Center Hackensack, New Jersey
Heart Center Research LLC Huntsville, Alabama
Helen Diller Medical Center at Parnassus Heights San Francisco, California
Henry Ford Health System - Nephrology Detroit, Michigan
Hopital Henri Mondor - Nephrology Créteil,
Hopital Necker Enfants Malades - Nephrology Paris,
Hopital Tenon Paris,
Hopital de la Conception Marseille,
Horizon Research Group - Coral Gables Coral Gables, Florida
Hospital Ana Nery/SESAB Salvador,
Hospital Clinic de Barcelona - Nephrology Barcelona,
Hospital Curry Cabral - Serviço de Nefrologia Lisbon,
Hospital Nord Michallon - Nephrology Grenoble,
Hospital Nove de Julho - Nephrology São Paulo,
Hospital São Lucas Rio de Janeiro,
Hospital Universitari Vall d´Hebron - Servicio de Pediatria Barcelona,
Hospital Universitario 12 de Octubre - Nephrology Madrid,
Hospital Universitario Pedro Ernesto - Departamento de Nefrologia Rio de Janeiro,
Hospital Universitario Pedro Ernesto - Departamento de Patologia Rio de Janeiro,
Hospital Universitario Virgen Macarena Seville,
Hospital das Clínicas da Faculdade de Medicina - Laboratório de Nefrologia Celular, Genética e Molecular São Paulo,
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto Monte Alegre,
Hospital de Clínicas de Porto Alegre - Nephrology Porto Alegre,
Hospital do Rim - Fundação Oswaldo Ramos São Paulo,
Houston Medical Research Institute, LLC Houston, Texas
Hôpital de Rangueil Toulouse,
ICM - Instituto do Coração de Marília Marília/SP,
IPECC - Instituto de Pesquisa Clinica de Campinas Campinas,
IU School of Medicine - Nephrology Indianapolis, Indiana
Icahn School of Medicine at Mount Sinai - Nephrology New York, New York
Infigo Clinical Research Sanford, Florida
Inova Clinical Trials and Research Center Tyrone, Georgia
Instituto Pro-Renal Curitiba,
Instituto de Ensino e Pesquisa Clinica do Ceara Fortaleza,
InterMed Consultants - Edina Clinic Edina, Minnesota
Irmandade Da Santa Casa De Misericordia De Sao Paulo São Paulo,
James J. Peters VA Medical Center The Bronx, New York
Javara Inc./Privia Medical Group - Annapolis, MD Annapolis, Maryland
Javara Inc./Privia Medical Group - Fayetteville, GA Fayetteville, Georgia
Javara Inc./Privia Medical Group - Savannah, GA Savannah, Georgia
Javara Inc./Privia Medical Group - Silver Spring, MD - Columbia Pike Silver Spring, Maryland
Jefferson Einstein Philadelphia Hospital - Nephrology Philadelphia, Pennsylvania
Jefferson Health - 33 South 9th Street Philadelphia, Pennsylvania
Jersey Shore University Medical Center Neptune City, New Jersey
Kaiser Permanente Georgia Atlanta, Georgia
Kaiser Permanente Los Angeles Medical Center Los Angeles, California
Kaiser Permanente Sacramento Medical Center Sacramento, California
Kidney Care Center of North Valley Granada Hills, California
Kidney Care and Transplant Services of New England - West Springfield West Springfield, Massachusetts
Kidney Medical Associates, PLLC The Bronx, New York
Kidney Specialists of N Houston, PLLC Shenandoah, Texas
Kidney and Hypertension Center Roseburg, Oregon
King's College Hospital - Pulmonology London,
Kings County Hospital Brooklyn, New York
Komfo Anokye Teaching Hospital - Nephrology Kumasi,
LCMC Health Metairie, Louisiana
Lagos State University Teaching Hospital Ikeja,
Lagos University Teaching Hospital Surulere, Lagos
Le Bonheur Children's Hospital - Outpatient Clinic Memphis, Tennessee
Leicester General Hospital Leicester,
Lewis Katz School of Medicine at Temple University - Section of Nephrology Philadelphia, Pennsylvania
Lifespan Clinical Research Center East Providence, Rhode Island
Louis Stokes Cleveland VA Medical Center Cleveland, Ohio
Louisiana Clinical and Translational Science (LA CaTS) Center New Orleans, Louisiana
Louisiana State University Health Shreveport Shreveport, Louisiana
MD Medical Research Oxon Hill, Maryland
Manchester Royal Infirmary - Endocrinology Manchester,
McGuire Research Institute, Inc. (151) Richmond, Virginia
MedBio Trials Miami, Florida
Medical College of Wisconsin - Pulmonology Milwaukee, Wisconsin
Medical University of South Carolina - Pulmonology Charleston, South Carolina
Mediservis del Tolima IPS S.A.S. Ibagué,
Metrolina Nephrology Associates - Freedom Dr Charlotte, North Carolina
Mid and South Essex Hospitals NHS Trust Basildon,
Mid-Atlantic Permanente Research Institute Gaithersburg, Maryland
Milwaukee Nephrologists - Wauwatosa Wauwatosa, Wisconsin
Minneapolis VA Healthcare System Minneapolis, Minnesota
Monroe Research, LLC West Monroe, Louisiana
Montefiore Einstein - Albert Einstein College of Medicine The Bronx, New York
Montefiore Einstein Hospital - Moses Campus The Bronx, New York
Morehouse School of Medicine, Grady Memorial Hospital Atlanta, Georgia
NANI Research LLC - Evergreen Park IL Evergreen Park, Illinois
NANI Research LLC - Fort Wayne IN Fort Wayne, Indiana
NTKDA Lewisville Lewisville, Texas
NYC Health + Hospital/Harlem New York, New York
Nashville General Hospital - Meharry Medical College - Nephrology Nashville, Tennessee
Nashville VA Medical Center Nashville, Tennessee
Nephrology & Hypertension Associates, PC Middlebury, Connecticut
Nephrology Associates Fairhope, Alabama
Nephrology Associates of Tidewater, LTD Virginia Beach, Virginia
Nephrology Associates, P.C. - Columbus Columbus, Mississippi
Nephrology Clinical Trials Center Nashville, Tennessee
Nephrology Consultants, LLC Huntsville, Alabama
Nephrology Physicians, LLC Mishawaka, Indiana
Nephrology and Hypertension Associates - Tupelo Tupelo, Mississippi
Nephrotex Research Group Dallas, Texas
Nevada Kidney Disease and Hypertension Centers Las Vegas, Nevada
New Mexico VA Healthcare System Albuquerque, New Mexico
New York Presbyterian Queens Flushing, New York
Nigerian Institute of Medical Research Lagos,
North Carolina Nephrology P.A. - Cary Cary, North Carolina
North Florida/South Georgia Veterans Health System Gainesville, Florida
Northwest Louisiana Nephrology, LLC Shreveport, Louisiana
Northwestern Medical Group Chicago, Illinois
Nottingham University Hospitals - Children's Clinical Research Facility - Pulmonology Nottingham,
Nova Clinical Research, LLC - Bradenton - 59th St Bradenton, Florida
Ochsner Medical Center - New Orleans New Orleans, Louisiana
Ohio State University - Wexner Medical Center - Nephrology Clinical Trials Unit Columbus, Ohio
Olive Branch Family Medical Center Olive Branch, Mississippi
Omega Research Orlando, LLC - Mercy Dr Orlando, Florida
PUC Trials - Unidade Epicenter Curitiba,
Patient First Clinical Trials Lutherville, Maryland
Pharmacorp Clinical Trials, Inc Charleston, South Carolina
Phoenix Children's Hospital, Inc. - Nephrology Phoenix, Arizona
Praxis Pesquisa Medica Santo André, São Paulo
Premier Clinical Research Overland Park, Kansas
Prime Clinical Research - Mansfield - Regency Parkway Mansfield, Texas
Prime Clinical Research Inc - Lewisville Lewisville, Texas
Prime Health and Wellness Fayette, Mississippi
Prolato Clinical Research Center - Kirby Dr Houston, Texas
Promotora Medica Las Americas S.A. - Clinica Las Americas Medellín,
QUEST Research Institute Farmington Hills, Michigan
Queen Elizabeth Hospital Birmingham Birmingham,
Qway Research Hialeah, Florida
Randomize Now - College Park College Park, Georgia
Recherche GCP Research Montreal,
Reina Sofia University Hospital - Nephrology Córdoba,
Renal Associates Columbus, Georgia
Renal Associates of Alabama, LLC Montgomery, Alabama
Renal Associates of Baton Rouge Baton Rouge, Louisiana
Renal Medicine Associates Albuquerque, New Mexico
Renal Research of Montgomery County, PLLC The Woodlands, Texas
Renal and Transplant Associates of New England, PC Springfield, Massachusetts
Ronald Ralph MD PA Houston, Texas
Rophe Adult and Pediatric Medicine Union City, Georgia
Royal Free Hospital - Nephrology London,
Rutgers Doctors Office Center Newark, New Jersey
SKY Integrative Medical Center Ridgeland, Mississippi
SUNY Downstate Health Sciences University Brooklyn, New York
San Antonio Kidney Disease Center Physicians Group - Medical Center San Antonio, Texas
San Antonio Kidney Disease Center Physicians Group - Westover Hills San Antonio, Texas
Santa Casa de Misericordia de Belo Horizonte Belo Horizonte,
Scott Research, Inc. Laurelton, New York
Shands Hospital - Nephrology Gainesville, Florida
Solano & Terront Servicios Medicos SAS - Unidad Integral de Endocrinologia - UNIENDO Bogotá,
South Florida Nephrology Research Coral Springs, Florida
South Florida Research Miami Springs, Florida
South Florida Research Institute Lauderdale Lakes, Florida
Southeast Kidney Associates East Point, Georgia
Southeast Renal Research Institute Chattanooga, Tennessee
Southwest Family Medicine Associates (SFMA) - Dallas Dallas, Texas
Sparrow Clinical Research Institute Lansing, Michigan
St George's Hospital London - Nephrology London,
St Pancras Clinical Research London,
St. Clair Nephrology Research Roseville, Michigan
St. Louis Children's Hospital - Nephrology St Louis, Missouri
St. Louis Heart and Vascular, P.C. St Louis, Missouri
Synexus Clinical Research - Atlanta (DRS) Atlanta, Georgia
Synexus Clinical Research - Chicago (DRS) Chicago, Illinois
Synexus Clinical Research - Glasgow (DRS) Bellshill,
Synexus Clinical Research - Midlands (DRS) Birmingham,
Synexus Clinical Research - NW Consortium Manchester (DRS) Manchester,
Synexus Clinical Research - New York (DRS) New York, New York
Synexus Clinical Research - Orlando Orlando, Florida
Texas Tech University Health Sciences Center Lubbock, Texas
The Bank Hospital Cantonments,
The George Washington University - GW Medical Faculty Associates Washington D.C., District of Columbia
The Johns Hopkins University - Johns Hopkins Hospital - Nephrology Baltimore, Maryland
The Kirklin Clinic - Nephrology Birmingham, Alabama
The Medical Research Group - Saint Agnes Medical Center Fresno, California
The Rogosin Kidney Center New York, New York
The Royal London Hospital - Nephrology London,
Tidewater Kidney Specialists - Church St. Norfolk, Virginia
Total Research Group, LLC Miami, Florida
Tranquil Clinical Research Webster, Texas
Tufts Medical Center Boston, Massachusetts
UAMS Medical Center - Pulmonology Little Rock, Arkansas
UC - DCI McMillan Research Unit Cincinnati, Ohio
UCI Center for Clinical Research Orange, California
UCLA Division of Nephrology Los Angeles, California
UCLA Lundquist Institute at Harbor-UCLA Medical Center Torrance, California
UChicago Medicine - Comer Children's Hospital Chicago, Illinois
UF Health Cardiovascular Center - Jacksonville Jacksonville, Florida
UH Cleveland Medical Center - Nephrology Cleveland, Ohio
UMMC Grenada Hospital Grenada, Mississippi
UNC Clinical and Translational Research Center Chapel Hill, North Carolina
UTSW Medical Center - Nephrology Dallas, Texas
UVA Health - Nephrology Clinical Research Center Charlottesville, Virginia
UW Medical Center - Montlake - Nephrology Seattle, Washington
Unidade Local de Saude Amadora/Sintra, E.P.E. Amadora,
Unidade Local de Saúde de Loures-Odivelas, E.P.E. Loures,
Unidade Local de Saúde de Santa Maria, E.P.E. - Nephrology Lisbon,
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg - Pulmonology Leuven,
Universite Catholique de Louvain - Pulmonology Woluwe-Saint-Lambert, Brussels Capital
University College Hospital London,
University Medical Center - New Orleans - Nephrology New Orleans, Louisiana
University of Ghana Medical School - Nephrology Accra,
University of Iowa Health Care Medical Center- Nephrology Iowa City, Iowa
University of Maryland Medical Center - General Clinical Research Center Baltimore, Maryland
University of Nigeria Teaching Hospital Enugu,
University of Puerto Rico San Juan,
University of Texas Health Science Center - Nephrology San Antonio, Texas
Université Paris-Descartes / Hôpital Européen Georges Pompidou Paris,
VA New York Harbor Healthcare System New York, New York
Velocity Clinical Research - Hallandale Beach Hallandale, Florida
Veterans Affairs Medical Center - Washington D.C Washington D.C., District of Columbia
Virginia Commonwealth University - Division of Nephrology Richmond, Virginia
Walter Cantídio University Hospital Fortaleza,
Whittier Street Health Center Roxbury, Massachusetts
Women's College Hospital Toronto, Ontario
Wythenshawe Hospital - Medicines Evaluation Unit Manchester,
Yale University - Yale Nephrology Clinical Research Clinic New Haven, Connecticut
York Clinical Research, LLC Norfolk, Virginia
Zenos Clinical Research Dallas, Texas
Zucker School of Medicine Great Neck, New York

Streamlined Treatment of Pulmonary Exacerbations in Pediatrics (STOP PEDS RCT)

Erika Enright - eenright@uw.edu

NCT06654752
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Inclusion Criteria:

• Age
• For main cohort and non-HEMT cohort: age 6 to \<19 years
• For preschool cohort: age 3 to \<6 years
• Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria:
• sweat chloride ≥ 60 mEq/liter
• two disease-causing variants in the cystic fibrosis transmembrane conductive regulator (CFTR) gene
• Written informed consent (and assent when applicable) obtained from participant or participant's legal representative and ability of participant to comply with the requirements of the study
• Highly Effective Modulator Therapy
• For main cohort and preschool cohort: Taking ETI or ivacaftor for at least 3 months at enrollment
• For non-HEMT cohort: not eligible for HEMT based on CFTR genotype or eligible but not taking for at least 3 months and no plans to start HEMT in the next year, and also not taking tezacaftor-ivacaftor or lumacaftor-ivacaftor for at least 3 months
• For main cohort and non-HEMT cohort: able to perform acceptable and reproducible spirometry
• For main cohort and non-HEMT cohort: ppFEV1 ≥ 50% predicted at enrollment based on the Global lung Initiative (GLI) reference equations
• Ability to receive text messages and access the internet
Exclusion Criteria:

• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the individual or the quality of the data
• Receiving an acute course of oral or IV antibiotics at the time of enrollment or within the 14 days prior to enrollment. Individuals may be re-screened ≥21 days after completion of antibiotics if they are at their baseline state of health, per self-report
• Treatment with systemic corticosteroids at enrollment or within the 14 days prior to enrollment. Individuals may be re- screened ≥21 days after completion of systemic corticosteroids if they are at their clinical baseline, per self-report
• History of solid organ transplant
• History of positive culture for Mycobacterium abscessus in the 12 months prior to enrollment
• Treatment with antibiotics for any non-tuberculous mycobacteria (NTM) at enrollment
• Three or more IV antibiotic-treated PEx in the 12 months prior to enrollment
• Treatment with chronic oral antibiotics other than azithromycin at enrollment
• Treatment with systemic corticosteroids for allergic bronchopulmonary aspergillosis (ABPA) in the 12 months prior to enrollment
OTHER: Immediate Oral Antibiotics, OTHER: Tailored Treatment: Oral Antibiotics only if Additional Treatment needed
Cystic Fibrosis
cystic fibrosis, oral antibiotics, pulmonary exacerbation, pediatric
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Ann & Robert H. Lurie Children's Hospital of Chicago & Northwestern University Chicago, Illinois Mariah Flowers - (maflowers@luriechildrens.org)
Boston Children's Hospital & Harvard University Boston, Massachusetts Ethan Ito - (ethan.ito@childrens.harvard.edu)
British Columbia Children's Hospital Vancouver, British Columbia Madison Weir - (Madison.Weir@bcchr.ca)
Children's Healthcare of Atlanta & Emory University Atlanta, Georgia Joy Dangerfield - (jdanger@emory.edu)
Children's Hospital of Colorado Aurora, Colorado Mary Cross - (Mary.Cross@childrenscolorado.org)
Children's Hospital of Los Angeles & Anton Yelchin Cystic Fibrosis Clinic Los Angeles, California Jared Lopez, BA - (jalopez@chla.usc.edu)
Children's Hospital of Philadelphia & University of Pennsylvania Philadelphia, Pennsylvania Matthew Gari - (garim@chop.edu) Erin Donnelly - (donnellye4@chop.edu)
Children's Hospital of Pittsburgh of UPMC & University of Pittsburgh Medical Center Pittsburgh, Pennsylvania Adrienne DeRicco, RN - (adrienne.dericco2@upmc.edu)
Children's Hospitals and Clinics of Minnesota Minneapolis, Minnesota Danniella Balangoy - (Danniella.Balangoy@childrensmn.org)
Children's Mercy Hospital Kansas City, Missouri Jana Lomonte - (jblomonte@cmh.edu)
Children's Wisconsin & Medical College of Wisconsin Milwaukee, Wisconsin Laura Roth, CCRC - (lroth@mcw.edu)
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio Sharon Kadon, RN, BSN, CPN - (sharon.kadon@cchmc.org)
Johns Hopkins Hospital, Johns Hopkins University Baltimore, Maryland Jamelia Maynard - (jmaynar8@jhmi.edu)
Medical University of South Carolina Charleston, South Carolina Audra Wiser - (wisera@musc.edu)
Oregon Health & Science University Portland, Oregon Pierce Nusbaum - (nusbaum@ohsu.edu)
Rady Children's Hospital at University of California San Diego San Diego, California Lisa Ramos, CRC - (lramosvallejo@health.ucsd.edu)
Riley Hospital for Children & Indiana University Indianapolis, Indiana Misty Thompson - (misthomp@iu.edu) Lisa Bendy - (lbendy@iu.edu)
Seattle Children's Hospital Seattle, Washington Mey Lee - (mey.lee@seattlechildrens.org)
St. Louis Children's Hospital & Washington University School of Medicine St Louis, Missouri Emily Schulte, RN, BSN - (e.burns@wustl.edu)
Stanford University Palo Alto, California Tina Conti, BSRC, RRT, RRT-NPS, C-NPT - (tconti@stanford.edu)
Texas Children's Hospital & Baylor College of Medicine Houston, Texas Pavel Tuekam - (OrnellaPavel.TuekamMeko@bcm.edu)
The Children's Hospital Alabama & University of Alabama at Birmingham Birmingham, Alabama Ashlyn Hastings - (aehastings@uabmc.edu)
The Hospital for Sick Children & Toronto Canada CF Centre Pediatrics Toronto, Ontario Claire Crompton - (claire.crompton@sickkids.ca)
The Minnesota Cystic Fibrosis Center & University of Minnesota Minneapolis, Minnesota Alyssa Perry - (ahperry@umn.edu)
Tucson Cystic Fibrosis Center Tucson, Arizona Elizabeth (Lisa) Ryan - (elizabethryan@arizona.edu)
University of Iowa Iowa City, Iowa Mary Teresi - (mary-teresi@uiowa.edu)
University of Michigan Health System Ann Arbor, Michigan Dawn Kruse - (dmkruse@med.umich.edu)
University of North Carolina at Chapel Hill Chapel Hill, North Carolina Caroline Flowers, CRC - (caroline_flowers@med.unc.edu)
University of Rochester Medical Center Strong Memorial Rochester, New York Barbara Johnson, RN - (Barbara_johnson@urmc.rochester.edu) Karen McCarthy - (karen_mccarthy@urmc.rochester.edu)
University of Texas Southwestern & Children's Health Dallas, Texas Lindsay Allen, CRC - (Lindsay.Allen@utsouthwestern.edu)
University of Wisconsin Madison, Wisconsin Melanie Nelson, BS, RRT, CCRC - (mmnelson@medicine.wisc.edu)
Vermont Children's Hospital & University of Vermont Medical Center Burlington, Vermont Vanessa Marascio - (Vanessa.Marascio@uvmhealth.org)
Virginia Commonwealth University Richmond, Virginia Akilah Pierre-Louis, CRC - (Akilah.PierreLouis1@vcuhealth.org)

A Study of Emapalumab for Pediatric Aplastic Anemia

Andromachi Scaradavou, MD - ScaradaA@mskcc.org

NCT06430788
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Inclusion Criteria:
* Patients undergoing workup for suspected newly diagnosed sAA: * Patients with severe cytopenias and a hypocellular marrow concerning for sAA * Patients that meet the definition for suspected sAA (Camitta Criteria) as follows: Marrow Cellularity: \<25%, or 25-50% with \<30% residual hematopoietic cells Peripheral cytopenias (at least 2 of 3) Absolute neutrophil count (ANC): \<500 x 10\^9/L Platelets: \<20 x 10\^9/L Absolute Reticulocyte Count: \<60 x 10\^9/L * Patients that do not have evidence of leukemia or MDS * Patients \< 25 years of age at time of diagnosis * Able to tolerate emapalumab and IST (with standard institutional organ function criteria)
Exclusion Criteria:
* Uncontrolled infection at presentation. * Patients who have undergone previous treatment for sAA. * Patients with known inherited bone marrow failure * Patient who has completed a full workup for sAA including having results back from telomere testing, DEB and genetics (when applicable), as well as having an appropriate willing and available donor and would otherwise be admitted for HSCT within 2 weeks of enrolling on the trial * Patients with leukemia or MDS * Patient or parent or guardian unable to give informed consent or unable to comply with the treatment protocol including research tests.
BIOLOGICAL: Emapalumab
Aplastic Anemia, Cytopenia, Hypocellular Marrow
pediatric aplastic anemia, aplastic anemia, cytopenia, hypocellular marrow, Emapalumab, Memorial Sloan Kettering Cancer Center, 23-278
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Children's Hospital of Philadelphia (Data Collection AND Specimen Analysis) Philadelphia, Pennsylvania
Children's Hospital of Wisconsin (Data Collection Only) Milwaukee, Wisconsin
Cincinnati Children's Hospital Medical Center (Data collection only) Cincinnati, Ohio Anthony Sabulski, MD - (anthony.sabulski@cchmc.org)
Medical College of Wisconsin (Data Collection AND Data Analysis) Milwaukee, Wisconsin
Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York, New York
Virginia Commonwealth University (Data Collection Only ) Richmond, Virginia

A Study of Treatment for Medulloblastoma Using Sodium Thiosulfate to Reduce Hearing Loss

ctrrecruit@vcu.edu

NCT05382338
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Inclusion Criteria:
* PRE-ENROLLMENT: Patients must be ≥ 4 years and ≤ 21 years of age at the time of enrollment * PRE-ENROLLMENT: Patient is suspected to have newly-diagnosed medulloblastoma by institutional diagnosis * Please note: Patients with a pending result of CSF cytology tests are eligible for NCI-2014-02057 (APEC14B1-Central Nervous System \[CNS\]) and CNS/Medulloblastoma Pre Enrollment Eligibility Screening * PRE-ENROLLMENT: The patient and/or their parents or legal guardians must have signed informed consent for APEC14B1 Part A - Eligibility Screening and consent for the Molecular Characterization Initiative (MCI) * PRE-ENROLLMENT: The required specimens are projected to be submitted under APEC14B1-CNS as soon as possible, preferably within 5 days of definitive surgery * PRE-ENROLLMENT: All patients must have rapid central pathology review under APEC14B1-CNS prior to study enrollment on ACNS2031 step 1 in order to avoid discordant diagnoses and to verify diagnosis criterion for treatment on ACNS2031. * Note: Patients with a pending result of CSF cytology tests are eligible for the rapid central pathology screening review. Confirmation of CSF negativity is needed for enrollment on the ACNS2031 protocol * PRE-ENROLLMENT: All patients must have rapid central molecular screening review under APEC14B1-CNS prior to study enrollment on ACNS2031 step 1, in order to avoid discordant diagnoses and to verify diagnosis criterion for treatment on ACNS2031 * PRE-ENROLLMENT: All patients who have histopathology confirmed must have rapid central imaging screening review under APEC14B1 prior to study enrollment on ACNS2031 step 1 * Note: Patients must not have metastatic disease on cranial or spinal MRI. Patients with \> 1.5 cm\^2 residual tumor after initial surgical resection may undergo a second surgical resection prior to subsequent therapy to render them eligible for this study. The day of the second resection to remove residual tumor will be regarded as the day of definitive surgery (Day 0) and must be within a month (31 days) of the initial resection * PRE-ENROLLMENT: All patients who have histopathology confirmed must have rapid central audiology review under APEC14B1-CNS prior to study enrollment on ACNS2031 step 1 * Patients must be \>= 4 years and =\< 21 years of age at the time of enrollment * Patients must be newly diagnosed and have eligibility confirmed by rapid central pathology and molecular screening reviews performed on APEC14B1 and via the Molecular Characterization Initiative * Average-risk cohort * Clinico-pathologic criteria: * M0 disease * No diffuse anaplastic histology AND * Molecular criteria: * SHH, p53wt, GLI2 normal, MYCN normal, no chromosome 14q loss * Group 3, MYC normal, no isochromosome 17q * Group 4, no chromosome 11 loss * Low-risk features cohort * Clinico-pathologic criteria: * M0 disease * No diffuse anaplastic histology AND * Molecular criteria: * Group 4, chromosome 11 loss * Patients must have negative lumbar CSF cytology * Note: CSF cytology for staging should be performed no sooner than 14 days post operatively to avoid false positive CSF. Ideally, CSF should be obtained between day 14 and day 21 to allow for final staging status before enrollment onto the study. Patients with positive CSF cytology obtained 0 to 14 days after surgery should have cytology repeated to determine eligibility and final CSF status. Patients with negative CSF cytology from lumbar puncture obtained 0 to 14 days after surgery do not need cytology repeated. Patients with negative CSF cytology from lumbar puncture obtained prior to surgery do not need cytology repeated post-operatively * Patients must have eligibility confirmed by Rapid Central Imaging Review performed on APEC14B1. Patients must have =\< 1.5 cm\^2 cross-sectional area of residual tumor. Whole brain MRI with and without gadolinium and spine MRI with gadolinium must be performed * Patients must weigh \> 10 kg * Patients must be enrolled, and protocol therapy must be projected to begin, no later than 31 days after definitive diagnostic surgery (day 0) * Peripheral absolute neutrophil count (ANC) \>= 1000/uL (within 7 days prior to enrollment) * Platelet count \>= 100,000/uL (transfusion independent) (within 7 days prior to enrollment) * Hemoglobin \>= 8.0 g/dL (may receive red blood cell count \[RBC\] transfusions) (within 7 days prior to enrollment) * A serum creatinine (within 7 days prior to enrollment) based on age/sex as follows: * 4 to \< 6 years (age); 0.8 mg/dL (male) 0.8 mg/dL (female) * 6 to \< 10 years (age); 1 mg/dL (male) 1 mg/dL (female) * 10 to \< 13 years (age); 1.2 mg/dL (male) 1.2 mg/dL (female) * 13 to \< 16 years (age); 1.5 mg/dL (male) 1.4 mg/dL (female) * \>= 16 years (age); 1.7 mg/dL (male) 1.4 mg/dL (female) OR a 24 hour urine Creatinine clearance \>= 70 mL/min/1.73 m\^2 (within 7 days prior to enrollment) OR a glomerular filtration rate (GFR) \>= 70 mL/min/1.73 m\^2 (within 7 days prior to enrollment). GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard) * Note: Estimated GFR (eGFR) from serum creatinine, cystatin C or other estimates are not acceptable for determining eligibility * Total bilirubin =\< 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment) * Serum glutamic pyruvic transaminase (SGPT) (alanine aminotransferase \[ALT\]) =\< 135 U/L (within 7 days prior to enrollment) * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L * Central nervous system function defined as: * Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled * Patients must not be in status epilepticus, a coma or assisted ventilation at the time of study enrollment * Auditory function defined as: * Patients must have normal hearing (defined as International Society of Pediatric Oncology \[SIOP\] grade 0) in at least one ear confirmed by rapid central audiology review performed on APEC14B1 prior to enrollment * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
Exclusion Criteria:
* Patients with metastatic disease by either MRI evaluation or lumbar CSF cytology are not eligible. Patients who are unable to undergo a lumbar puncture for assessment of CSF cytology are ineligible * Patients must not have received any prior radiation therapy or chemotherapy (tumor-directed therapy) other than surgical intervention and/or corticosteroids * Patients must not have any known hypersensitivity to STS, sulfates/sulfites, or other thiol agents (e.g., amifostine, n-acetylcysteine, MESNA, and captopril) * Pregnancy and Breastfeeding: * Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential * Lactating females who plan to breastfeed their infants * Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation
PROCEDURE: Audiometric Test, PROCEDURE: Auditory Brainstem Response, PROCEDURE: Biospecimen Collection, DRUG: Cisplatin, DRUG: Cyclophosphamide, DRUG: Lomustine, PROCEDURE: Magnetic Resonance Imaging, OTHER: Quality-of-Life Assessment, RADIATION: Radiation Therapy, DRUG: Sodium Thiosulfate, OTHER: Survey Administration, DRUG: Vincristine
Childhood Medulloblastoma
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Location Contacts
Albany Medical Center Albany, New York
Alfred I duPont Hospital for Children Wilmington, Delaware Site Public Contact - (Allison.bruce@nemours.org)
Arkansas Children's Hospital Little Rock, Arkansas
Arnold Palmer Hospital for Children Orlando, Florida Site Public Contact - (Jennifer.spinelli@orlandohealth.com)
BI-LO Charities Children's Cancer Center Greenville, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
C S Mott Children's Hospital Ann Arbor, Michigan
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL) Québec, Site Public Contact - (rechclinique@crchudequebec.ulaval.ca)
Cardinal Glennon Children's Medical Center St Louis, Missouri
Carolinas Medical Center/Levine Cancer Institute Charlotte, North Carolina
Centre Hospitalier Universitaire Sainte-Justine Montreal, Quebec Site Public Contact - (yvan.samson@umontreal.ca)
Centre Hospitalier Universitaire de Sherbrooke-Fleurimont Sherbrooke, Quebec Site Public Contact - (crcinformation.chus@ssss.gouv.qc.ca)
Children's Healthcare of Atlanta - Arthur M Blank Hospital Atlanta, Georgia Site Public Contact - (Olivia.Floyd@choa.org)
Children's Hospital Colorado Aurora, Colorado Site Public Contact - (josh.b.gordon@nsmtp.kp.org)
Children's Hospital Los Angeles Los Angeles, California
Children's Hospital Medical Center Of Akron Akron, Ohio
Children's Hospital New Orleans New Orleans, Louisiana
Children's Hospital and Medical Center of Omaha Omaha, Nebraska
Children's Hospital of Alabama Birmingham, Alabama
Children's Hospital of Michigan Detroit, Michigan Site Public Contact - (helpdesk@childrensoncologygroup.org)
Children's Hospital of Orange County Orange, California Site Public Contact - (oncresearch@choc.org)
Children's Hospital of Philadelphia Philadelphia, Pennsylvania Site Public Contact - (CancerTrials@email.chop.edu)
Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania Site Public Contact - (jean.tersak@chp.edu)
Children's Hospital of San Antonio San Antonio, Texas Site Public Contact - (bridget.medina@christushealth.org)
Children's Hospital of Wisconsin Milwaukee, Wisconsin Site Public Contact - (MACCCTO@mcw.edu)
Children's Hospitals and Clinics of Minnesota - Minneapolis Minneapolis, Minnesota Site Public Contact - (pauline.mitby@childrensmn.org)
Children's Mercy Hospitals and Clinics Kansas City, Missouri Site Public Contact - (COGResearchGroup@cmh.edu)
Children's National Medical Center Washington D.C., District of Columbia Site Public Contact - (OncCRC_OnCall@childrensnational.org)
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio Site Public Contact - (cancer@cchmc.org)
Connecticut Children's Medical Center Hartford, Connecticut
Corewell Health Children's Royal Oak, Michigan
Dayton Children's Hospital Dayton, Ohio
Dell Children's Medical Center of Central Texas Austin, Texas Site Public Contact - (TXAUS-DL-SFCHemonc.research@ascension.org)
East Carolina University Greenville, North Carolina Site Public Contact - (eubankss@ecu.edu)
El Paso Children's Hospital El Paso, Texas Site Public Contact - (ranjan.bista@ttuhsc.edu)
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Golisano Children's Hospital of Southwest Florida Fort Myers, Florida Site Public Contact - (molly.arnstrom@leehealth.org)
IWK Health Centre Halifax, Nova Scotia Site Public Contact - (Research@iwk.nshealth.ca)
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Kaiser Permanente-Oakland Oakland, California Site Public Contact - (Kpoct@kp.org)
Legacy Emanuel Children's Hospital Portland, Oregon
Loma Linda University Medical Center Loma Linda, California
Marshfield Medical Center-Marshfield Marshfield, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Mary Bridge Children's Hospital and Health Center Tacoma, Washington Site Public Contact - (research@multicare.org)
Massachusetts General Hospital Cancer Center Boston, Massachusetts
Mayo Clinic in Rochester Rochester, Minnesota
Medical City Dallas Hospital Dallas, Texas
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood, Florida Site Public Contact - (OHR@mhs.net)
Miller Children's and Women's Hospital Long Beach Long Beach, California
Montefiore Medical Center - Moses Campus The Bronx, New York Site Public Contact - (eskwak@montefiore.org)
Mount Sinai Hospital New York, New York Site Public Contact - (CCTO@mssm.edu)
Nationwide Children's Hospital Columbus, Ohio Site Public Contact - (Melinda.Triplet@nationwidechildrens.org)
Nemours Children's Clinic - Pensacola Pensacola, Florida Site Public Contact - (helpdesk@childrensoncologygroup.org)
Nemours Children's Clinic-Jacksonville Jacksonville, Florida Site Public Contact - (Allison.bruce@nemours.org)
Nemours Children's Hospital Orlando, Florida Site Public Contact - (Allison.bruce@nemours.org)
New York Medical College Valhalla, New York
Newark Beth Israel Medical Center Newark, New Jersey Site Public Contact - (Christine.Kosmides@rwjbh.org)
Nicklaus Children's Hospital Miami, Florida
Norton Children's Hospital Louisville, Kentucky Site Public Contact - (CancerResource@nortonhealthcare.org)
Oregon Health and Science University Portland, Oregon Site Public Contact - (trials@ohsu.edu)
Phoenix Childrens Hospital Phoenix, Arizona
Prisma Health Richland Hospital Columbia, South Carolina Site Public Contact - (Kim.Williams3@prismahealth.org)
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital Toledo, Ohio Site Public Contact - (PCIOncResearch@promedica.org)
Providence Sacred Heart Medical Center and Children's Hospital Spokane, Washington Site Public Contact - (HopeBeginsHere@providence.org)
Rady Children's Hospital - San Diego San Diego, California
Rainbow Babies and Childrens Hospital Cleveland, Ohio
Rhode Island Hospital Providence, Rhode Island
Riley Hospital for Children Indianapolis, Indiana
Roswell Park Cancer Institute Buffalo, New York Site Public Contact - (askroswell@roswellpark.org)
Saint Joseph's Hospital/Children's Hospital-Tampa Tampa, Florida Site Public Contact - (jennifer.manns@baycare.org)
Saint Joseph's Regional Medical Center Paterson, New Jersey Site Public Contact - (HallL@sjhmc.org)
Saint Jude Midwest Affiliate Peoria, Illinois
Saint Peter's University Hospital New Brunswick, New Jersey Site Public Contact - (kcovert@saintpetersuh.com)
Sanford Broadway Medical Center Fargo, North Dakota Site Public Contact - (OncologyClinicalTrialsFargo@sanfordhealth.org)
Sanford USD Medical Center - Sioux Falls Sioux Falls, South Dakota Site Public Contact - (OncologyClinicalTrialsSF@SanfordHealth.org)
Seattle Children's Hospital Seattle, Washington
Sinai Hospital of Baltimore Baltimore, Maryland
Southern Illinois University School of Medicine Springfield, Illinois
State University of New York Upstate Medical University Syracuse, New York
Stony Brook University Medical Center Stony Brook, New York
The Steven and Alexandra Cohen Children's Medical Center of New York New Hyde Park, New York
UCSF Medical Center-Mission Bay San Francisco, California Site Public Contact - (cancertrials@ucsf.edu)
UNC Lineberger Comprehensive Cancer Center Chapel Hill, North Carolina Site Public Contact - (cancerclinicaltrials@med.unc.edu)
USA Health Strada Patient Care Center Mobile, Alabama
UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas Site Public Contact - (canceranswerline@UTSouthwestern.edu)
University of Illinois Chicago, Illinois
University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami, Florida
University of Mississippi Medical Center Jackson, Mississippi
University of Nebraska Medical Center Omaha, Nebraska Site Public Contact - (unmcrsa@unmc.edu)
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma Site Public Contact - (ou-clinical-trials@ouhsc.edu)
University of Texas Health Science Center at San Antonio San Antonio, Texas Site Public Contact - (phoresearchoffice@uthscsa.edu)
University of Virginia Cancer Center Charlottesville, Virginia Site Public Contact - (uvacancertrials@hscmail.mcc.virginia.edu)
University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin Site Public Contact - (clinicaltrials@cancer.wisc.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)
Valley Children's Hospital Madera, California Site Public Contact - (Research@valleychildrens.org)
Vanderbilt University/Ingram Cancer Center Nashville, Tennessee
Wake Forest University Health Sciences Winston-Salem, North Carolina
Washington University School of Medicine St Louis, Missouri Site Public Contact - (info@siteman.wustl.edu)
Yale University New Haven, Connecticut Site Public Contact - (canceranswers@yale.edu)

A Study Observing Everyday Effectiveness and Safety of the Drug Elafibranor in Participants With Primary Biliary Cholangitis Who Are Receiving Ongoing Treatment (ELFINITY)

Ipsen Clinical Study Enquiries - clinical.trials@ipsen.com

NCT06447168
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Inclusion Criteria:
* Participant has provided written informed consent and agrees to comply with the study protocol. * Participant with PBC diagnosis. * Participant for whom the treating physician has decided to start or participants who are currently receiving treatment with commercialized elafibranor. * If a participant has a caregiver who agrees to complete the caregiver questionnaires, an informed consent should be collected from the caregiver before any data is collected.
Exclusion Criteria:
* Participant is currently participating or, plans to participate in an investigational drug study or medical device study containing active substance. * Participant with known hypersensitivity to the product or to any of its excipients. * Participant with mental instability or incompetence, such that the validity of informed consent or ability to be compliant with the study is uncertain.
Primary Biliary Cholangitis
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Study Locations

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Location Contacts
(G.I.R.I) GI Research Institute Foundation Vancouver,
A. Gemelli University Hospital, Catholic University of the Sacred Heart Roma,
ASST Grande Ospedale Metropolitano Niguarda Milan,
ASST-Ospedale Papa Giovanni XXIII Bergamo,
Aberdeen Royal Infirmary NHS Grampian Grampian Health Board Aberdeen,
Baylor College of Medicine - Advanced Liver Therapies Houston, Texas
Belfast Health and Social Care Trust - Royal Victoria Hospital Belfast,
Beth Israel Deaconess Medical Center, Liver Research Center Boston, Massachusetts
Bon Secours Richmond Community Hospital LLC. d/b/a Bon Secours Liver Institute of Richmond Richmond, Virginia
Bradford Royal Infirmary - Bradford Teaching Hospitals NHS Foundation Bradford,
Cedars-Sinai Medical Center Los Angeles, California
Charité Universitätsmedizin Berlin Berlin, State of Berlin
Clemenceau Medical Center Hospital Dubai,
Cleveland Clinic Foundation Cleveland, Ohio
DRK Kliniken Berlin Mitte Berlin,
Fondazione Policlinico Universitario Campus Bio-Medico Roma,
Gastro health & Nutrition Seattle, Washington
Gastroenterologsiche Studiengesellschaft Herne Herne,
General Hospital of Athens Laiko Athens,
Hospital of the Merciful Brothers Trier Trier,
Hull Royal Infirmary - Hull University Teaching Hospitals NHS Trust Hull,
Intermountain Medical Center Murray, Utah
Ippokratio General Hospital of Thessaloniki Thessaloniki,
John Radcliffe Hospital - Oxford University Hospitals NHS Foundation Trust Oxford,
King's College Hospital NHS Foundation Trust London,
Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt,
Liver Center of Texas Dallas, Texas
London Health Sciences Centre (LHSC) - University Hospital London,
Medical University Innsbruck Innsbruck,
Medical University of South Carolina (MUSC) Charleston, South Carolina
Mediclinic Airport Road Hospital Dubai,
Medizinische Universitaetsklinik Graz Graz,
Northwell Health Inc, Center for Liver Disease and Transplantation Manhasset, New York
Ospedale Garibaldi Nesima Catania,
Ospedale Maggiore Della Carita Novara,
Queen Elizabeth Hospital Birmingham - University Hospitals Birmingham NHS Foundation Trust Birmingham,
Queen's Medical Centre - Nottingham University Hospitals NHS Trust Nottingham,
Rashid Hospital Dubai,
Schiff Center for Liver Diseases - University of Miami Miami, Florida
Sheikh Shakhbout Medical City Dubai,
South Denver Gastroenterology,P.C. Englewood, Colorado
Southern California Research Center Coronado, California
Studiengesellschaft BSF Halle,
The Newcastle upon Tyne Hospitals NHS Foundation Trust - Freeman Hospital Newcastle,
The Ottawa Hospital - General Campus Ottawa,
Universita Degli Studi Di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC) Florence,
Universitaet des Saarlandes Homburg,
Universitaetsklinikum Leipzig Leipzig,
University General Hospital of Larissa Larissa,
University General Hospital of Patras Pátrai,
University Hospital of Heraklion Heraklion - Crete,
University of Calgary Calgary, Alberta
University of California Davis Medical Center Sacramento, California
Velocity Clinical Research Mobile, Alabama
Virginia Commonwealth University Medical Center - West Hospital Richmond, Virginia
Virtua Center for Liver Disease - Cherry Hill Cherry Hill, New Jersey
Yale University School of Medicine New Haven, Connecticut

Comparing Combinations of Drugs to Treat Newly Diagnosed Multiple Myeloma (NDMM) When a Stem Cell Transplant is Not a Medically Suitable Treatment

Sharon Palmer - spalmer@swog.org

NCT05561387
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Inclusion Criteria:
* Participants must have documented multiple myeloma satisfying standard International Myeloma Working Group (IMWG) diagnostic criteria within 28 days prior to registration * Participants must have measurable disease within 28 days prior to registration as defined by any of the following: * Immunoglobulin (Ig) G myeloma (serum monoclonal paraprotein \[M-protein\] level \>= 0.5 gram/deciliter \[g/dL\] or urine M-protein level \>= 200 milligram\[mg\]/24 hours\[hrs\]); OR * IgA, IgM, IgD, or IgE multiple myeloma (serum M-protein level \>= 0.2 g/dL or urine M-protein level \>= 200 mg/24 hrs); OR * Light chain multiple myeloma (serum immunoglobulin free light chain \>= 10 mg/dL and abnormal serum immunoglobulin kappa lambda free light chain ratio) * All disease must be assessed and documented on the baseline/pre-registration tumor assessment form * Participants must have a calculated myeloma frailty index (Myeloma Frailty Score Calculator; http://www.myelomafrailtyscorecalculator.net/) categorized as frail or intermediate fit (regardless of age) within 28 days prior to registration * For Participants Meeting "Frail" Status: * Participants with any degree of kidney dysfunction are allowed; however, participants on dialysis are not eligible * For Participants Meeting "Frail" Status: * Hemoglobin \>= 7 g/dL (must be performed within 28 days prior to registration) * Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM) * For Participants Meeting "Frail" Status: * Platelets \>= 50 x 10\^9/L (must be performed within 28 days prior to registration) * Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM) * For Participants Meeting "Frail" Status: * Absolute neutrophil count (ANC) \>= 0.75 x10\^9/L (must be performed within 28 days prior to registration) * Note: growth factor and transfusion utilization are allowed if cytopenias are considered secondary to bone marrow involvement from MM) * For Participants Meeting "Intermediate Fit" Status, one or more of the following criteria must be present: * Kidney dysfunction showing calculated creatinine clearance (CrCl) \<30 ml/min. * Actual lab serum creatinine value with a minimum of 0.7 mg/dL. * Participants must have bone marrow function assessed and meet the below criteria ranges: * Hemoglobin between 7-8 g/dL, OR * Platelets between 50-75 x10\^9/L, OR * ANC between 0.75-1 x10\^9/L * Note: growth factor and transfusion utilization are allowed as long as cytopenias are considered secondary to bone marrow involvement from MM) * Revised International Staging System (R-ISS) stage III disease * Note: All labs must be performed within 28 days prior to registration * Participants must have a complete medical history and physical exam within 28 days prior to registration * Participants must have whole body imaging within 60 days prior to registration. The recommended method of imaging is a positron emission tomography/computed tomography (PET/CT); a low-dose whole body CT scan or whole-body magnetic resonance imaging (MRI) or skeletal survey should be done only if a PET/CT scan cannot be done or is non-feasible. This must be documented in the comments section of the Onstudy form. * Total bilirubin =\< 2 times institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin =\< 5 x institutional ULN (within 28 days prior to registration) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 × institutional ULN (within 28 days prior to registration) * Participants must have adequate cardiac function, as assessed by the treating physician within 14 days prior to registration. Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification and must not be assessed as class 3 or 4 * Participants with known diabetes must show evidence of controlled disease within 14 days prior to registration. Uncontrolled diabetes is defined as: A glycosylated hemoglobin (Hg)A1C \> 7 * Participants with known human immunodeficiency virus (HIV)-infection must be receiving anti-retroviral therapy and have an undetectable viral load test on the most recent test result obtained, within 6 months prior to registration * All participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load on suppressive therapy within 28 days prior to registration * Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, participant must have an undetectable HCV viral load within 28 days prior to registration * Participants must have an Eastern Cooperative Oncology Group (ECOG)/Zubrod performance status score of 0-2 (Note: Participants with ECOG/Zubrod performance score \[PS\] 3, especially where the deterioration of PS is considered secondary to the MM diagnosis, will be allowed) * Participants must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) specimen tracking system * Participants who are able to complete the patient-reported outcomes measures in English or Spanish must agree to participate in the PRO portion of the study * Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines. For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and Central Institutional Review Board (CIRB) regulations
Exclusion Criteria:
* Participants must not have received any prior systemic therapy for multiple myeloma with the exception of any one or more of the following: * An emergency use of a short course of corticosteroids (equivalent of dexamethasone 160 mg) any time before registration, or * Up to one complete cycle of a non-daratumumab and hyaluronidase-fihj containing anti-myeloma regimen (1 cycle = 21 or 28 days depending on the regimen being used), or * Localized palliative radiation therapy for multiple myeloma, as long as the radiation therapy is completed at least 3 days prior to starting the systemic treatment as per the study protocol. * Participants must not have evidence of grade 4 peripheral neuropathy prior to study registration * Participants must not have uncontrolled blood pressure within 14 days prior to registration. Uncontrolled blood pressure: systolic blood pressure (SBP) \> 140 mmHg or diastolic blood pressure (DBP) \> 90 mmHg. Participants are permitted to be receiving multiple anti-hypertensive medications (unless otherwise indicated in the study). All blood pressure measurements within the 14 days prior to registration must be SBP =\< 140 and DBP =\< 90. A participant with a single blood pressure elevation who upon rechecking has a normal blood pressure will remain eligible at the discretion of the registering investigator. * Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or efficacy assessment of the investigational regimen. * Participants must not be pregnant or nursing. Individuals who are of reproductive potential must have agreed to use an effective contraceptive method with details provided as a part of the consent process. A person who has had menses at any time in the preceding 24 consecutive months or who has semen likely to contain sperm is considered to be of "reproductive potential." In addition to routine contraceptive methods, "effective contraception" also includes refraining from sexual activity that might result in pregnancy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) including hysterectomy, bilateral oophorectomy, bilateral tubal ligation/occlusion, and vasectomy with testing showing no sperm in the semen.
DRUG: Bortezomib, DRUG: Daratumumab and Hyaluronidase-fihj, DRUG: Dexamethasone, DRUG: Lenalidomide, OTHER: Quality-of-Life Assessment, OTHER: Questionnaire Administration
Plasma Cell Myeloma
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Study Locations

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21st Century Oncology-Pontiac Pontiac, Michigan Site Public Contact - (Emily.Crofts@trinity-health.org)
Abbott-Northwestern Hospital Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Academic Hematology Oncology Specialists Grosse Pointe Woods, Michigan Site Public Contact - (karen.forman@ascension.org)
Advanced Breast Care Center PLLC Warren, Michigan Site Public Contact - (karen.forman@ascension.org)
Alaska Breast Care and Surgery LLC Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Alaska Oncology and Hematology LLC Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Alaska Women's Cancer Care Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Alegent Health Bergan Mercy Medical Center Omaha, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Alegent Health Immanuel Medical Center Omaha, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Alegent Health Lakeside Hospital Omaha, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Alegent Health Mercy Hospital Council Bluffs, Iowa
Anchorage Associates in Radiation Medicine Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Anchorage Oncology Centre Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Anchorage Radiation Therapy Center Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Armes Family Cancer Center Findlay, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Ascension Borgess Cancer Center Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Ascension Saint John Hospital Detroit, Michigan Site Public Contact - (karen.forman@ascension.org)
Ascension Saint Joseph Hospital Tawas City, Michigan Site Public Contact - (lori.srebinski@ascension.org)
Ascension Saint Mary's Hospital Saginaw, Michigan Site Public Contact - (lori.srebinski@ascension.org)
Ascension Saint Mary's Hospital Saginaw, Michigan Site Public Contact - (Beth.Knetter@aspirus.org)
Ascension Saint Michael's Hospital Stevens Point, Wisconsin Site Public Contact - (Beth.Knetter@aspirus.org)
Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids, Wisconsin
Aspirus Medford Hospital Medford, Wisconsin Site Public Contact - (Beth.Knetter@aspirus.org)
Aspirus Regional Cancer Center Wausau, Wisconsin
Avera Cancer Institute Sioux Falls, South Dakota Site Public Contact - (OncRegulatory@avera.org)
Avera Cancer Institute at Yankton Yankton, South Dakota Site Public Contact - (OncRegulatory@avera.org)
Avera Cancer Institute-Aberdeen Aberdeen, South Dakota Site Public Contact - (oncregulatory@avera.org)
BJC Outpatient Center at Sunset Hills Sunset Hills, Missouri
Bay Area Hospital Coos Bay, Oregon Site Public Contact - (cherie.cox@bayareahospital.org)
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas Site Public Contact - (burton@bcm.edu)
Ben Taub General Hospital Houston, Texas
Bethesda North Hospital Cincinnati, Ohio Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Bhadresh Nayak MD PC-Sterling Heights Sterling Heights, Michigan Site Public Contact - (karen.forman@ascension.org)
Blanchard Valley Hospital Findlay, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Borgess Medical Center Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Bronson Battle Creek Battle Creek, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Bronson Methodist Hospital Kalamazoo, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
CARTI Cancer center Little Rock, Arkansas Site Public Contact - (Research@CARTI.com)
CHI Health Good Samaritan Kearney, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Cambridge Medical Center Cambridge, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Cancer Care Center of O'Fallon O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Care Specialists of Illinois - Decatur Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Cancer Center at Saint Joseph's Phoenix, Arizona Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Cancer Center of Western Wisconsin New Richmond, Wisconsin Site Public Contact - (mmcorc@healthpartners.com)
Cancer and Hematology Centers of Western Michigan - Norton Shores Norton Shores, Michigan Site Public Contact - (connie.szczepanek@crcwm.org)
Capital Region Southwest Campus Jefferson City, Missouri Site Public Contact - (amy.franken@health.missouri.edu)
Carle Cancer Center Urbana, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Effingham Effingham, Illinois Site Public Contact - (Research@carle.com)
Carle Physician Group-Mattoon/Charleston Mattoon, Illinois Site Public Contact - (Research@carle.com)
Carle at The Riverfront Danville, Illinois Site Public Contact - (Research@Carle.com)
Caro Cancer Center Caro, Michigan Site Public Contact - (lori.srebinski@ascension.org)
Central Care Cancer Center - Bolivar Bolivar, Missouri Site Public Contact - (aroland@kccop.org)
Central Care Cancer Center - Garden City Garden City, Kansas Site Public Contact - (aroland@kccop.org)
Central Care Cancer Center - Great Bend Great Bend, Kansas Site Public Contact - (aroland@kccop.org)
Centralia Oncology Clinic Centralia, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Clackamas Radiation Oncology Center Clackamas, Oregon Site Public Contact - (CanRsrchStudies@providence.org)
Commonwealth Cancer Center-Corbin Corbin, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Community Medical Center Missoula, Montana Site Public Contact - (HemonCCTrials@geisinger.edu)
Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Corewell Health Lakeland Hospitals - Niles Hospital Niles, Michigan
Corewell Health Reed City Hospital Reed City, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Cox Cancer Center Branson Branson, Missouri
CoxHealth South Hospital Springfield, Missouri
Creighton University Medical Center Omaha, Nebraska Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Crossroads Cancer Center Effingham, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Dayton Physician LLC-Miami Valley Hospital North Dayton, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Dayton Physicians LLC - Troy Troy, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Dayton Physicians LLC-Atrium Franklin, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Dayton Physicians LLC-Miami Valley South Centerville, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Dayton Physicians LLC-Wayne Greenville, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Decatur Memorial Hospital Decatur, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Delbert Day Cancer Institute at PCRMC Rolla, Missouri Site Public Contact - (research@phelpshealth.org)
Duluth Clinic Ashland Ashland, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
Edward Hines Jr VA Hospital Hines, Illinois
Essentia Health - Baxter Clinic Baxter, Minnesota
Essentia Health - Deer River Clinic Deer River, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - Ely Clinic Ely, Minnesota
Essentia Health - Fosston Fosston, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - International Falls Clinic International Falls, Minnesota
Essentia Health - Jamestown Clinic Jamestown, North Dakota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health - Moose Lake Clinic Moose Lake, Minnesota
Essentia Health - Park Rapids Park Rapids, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Cancer Center Duluth, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Cancer Center-South University Clinic Fargo, North Dakota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Hibbing Clinic Hibbing, Minnesota
Essentia Health Saint Joseph's Medical Center Brainerd, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Saint Mary's Hospital - Superior Superior, Wisconsin
Essentia Health Saint Mary's Medical Center Duluth, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Sandstone Sandstone, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health Virginia Clinic Virginia, Minnesota Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health-Hayward Clinic Hayward, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
Essentia Health-Spooner Clinic Spooner, Wisconsin Site Public Contact - (CancerTrials@EssentiaHealth.org)
Exeter Hospital Exeter, New Hampshire
Fairview Clinics and Surgery Center Maple Grove Maple Grove, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fairview Lakes Medical Center Wyoming, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fairview Northland Medical Center Princeton, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Fairview Southdale Hospital Edina, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Flaget Memorial Hospital Bardstown, Kentucky Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Freeman Health System Joplin, Missouri Site Public Contact - (LJCrockett@freemanhealth.com)
Fremont - Rideout Cancer Center Marysville, California
Geisinger Medical Center Danville, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Medical Oncology-Lewisburg Lewisburg, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre, Pennsylvania Site Public Contact - (HemonCCTrials@geisinger.edu)
Gene Upshaw Memorial Tahoe Forest Cancer Center Truckee, California
Genesee Cancer and Blood Disease Treatment Center Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Genesee Hematology Oncology PC Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Genesys Hurley Cancer Institute Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Good Samaritan Hospital - Cincinnati Cincinnati, Ohio Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Good Samaritan Regional Health Center Mount Vernon, Illinois
Great Lakes Cancer Management Specialists-Doctors Park East China, Michigan Site Public Contact - (karen.forman@ascension.org)
Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb, Michigan Site Public Contact - (karen.forman@ascension.org)
Great Lakes Cancer Management Specialists-Macomb Professional Building Warren, Michigan Site Public Contact - (karen.forman@ascension.org)
Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods, Michigan Site Public Contact - (karen.forman@ascension.org)
Greater Baltimore Medical Center Baltimore, Maryland
Greater Dayton Cancer Center Kettering, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Greater Regional Medical Center Creston, Iowa Site Public Contact - (cancerresearch@mercydesmoines.org)
Gundersen Lutheran Medical Center La Crosse, Wisconsin Site Public Contact - (cancerctr@gundersenhealth.org)
HSHS Saint Elizabeth's Hospital O'Fallon, Illinois Site Public Contact - (morganthaler.jodi@mhsil.com)
Harrison Medical Center Bremerton, Washington Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Health Partners Inc Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Heartland Regional Medical Center Saint Joseph, Missouri Site Public Contact - (linda.schumacher@mymlc.com)
Helen DeVos Children's Hospital at Spectrum Health Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Hematology Oncology Consultants-Clarkston Clarkston, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Hennepin County Medical Center Minneapolis, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Holy Cross Hospital Fort Lauderdale, Florida Site Public Contact - (eileen.georgi@holy-cross.com)
Hope Cancer Center Pontiac, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
Hurley Medical Center Flint, Michigan Site Public Contact - (wstrong@ghci.org)
Huron Gastroenterology PC Ypsilanti, Michigan Site Public Contact - (MCRCwebsitecontactform@stjoeshealth.org)
IU Health North Hospital Carmel, Indiana Site Public Contact - (iutrials@iu.edu)
Illinois CancerCare - Washington Washington, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Bloomington Bloomington, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Canton Canton, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Carthage Carthage, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Dixon Dixon, Illinois
Illinois CancerCare-Eureka Eureka, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Galesburg Galesburg, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Kewanee Clinic Kewanee, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Macomb Macomb, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Ottawa Clinic Ottawa, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Pekin Pekin, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Peoria Peoria, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Peru Peru, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Illinois CancerCare-Princeton Princeton, Illinois Site Public Contact - (andersonj@illinoiscancercare.com)
Indiana University/Melvin and Bren Simon Cancer Center Indianapolis, Indiana Site Public Contact - (iutrials@iu.edu)
Indu and Raj Soin Medical Center Beavercreek, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
John L McClellan Memorial Veterans Hospital Little Rock, Arkansas
Jupiter Medical Center Jupiter, Florida
Kadlec Clinic Hematology and Oncology Kennewick, Washington Site Public Contact - (research@kadlecmed.org)
Katmai Oncology Group Anchorage, Alaska Site Public Contact - (AKPAMC.OncologyResearchSupport@providence.org)
Kettering Medical Center Kettering, Ohio Site Public Contact - (clinical.trials@daytonncorp.org)
Lake Regional Hospital Osage Beach, Missouri Site Public Contact - (clinicaltrials@lakeregional.com)
Lakeland Medical Center Saint Joseph Saint Joseph, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Lakeview Hospital Stillwater, Minnesota Site Public Contact - (mmcorc@healthpartners.com)
Langlade Hospital and Cancer Center Antigo, Wisconsin Site Public Contact - (Juli.Alford@aspirus.org)
Lehigh Valley Hospital - Muhlenberg Bethlehem, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Lehigh Valley Hospital-Cedar Crest Allentown, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Lehigh Valley Hospital-Hazleton Hazleton, Pennsylvania Site Public Contact - (Morgan_M.Horton@lvhn.org)
Littleton Adventist Hospital Littleton, Colorado
Longmont United Hospital Longmont, Colorado Site Public Contact - (ResearchInstituteInquiries@CommonSpirit.org)
Lovelace Medical Center-Saint Joseph Square Albuquerque, New Mexico Site Public Contact - (AYost@nmcca.org)
Loyola Center for Health at Burr Ridge Burr Ridge, Illinois
Loyola Medicine Homer Glen Homer Glen, Illinois
Loyola University Medical Center Maywood, Illinois
M D Anderson Cancer Center Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
MD Anderson League City League City, Texas Site Public Contact - (askmdanderson@mdanderson.org)
MD Anderson West Houston Houston, Texas Site Public Contact - (askmdanderson@mdanderson.org)
MD Anderson in Sugar Land Sugar Land, Texas Site Public Contact - (askmdanderson@mdanderson.org)
MD Anderson in The Woodlands Conroe, Texas Site Public Contact - (askmdanderson@mdanderson.org)
Macomb Hematology Oncology PC Warren, Michigan Site Public Contact - (karen.forman@ascension.org)
Marjorie Weinberg Cancer Center at Loyola-Gottlieb Melrose Park, Illinois
Marshall Cancer Center Cameron Park, California Site Public Contact - (cancerservices@marshallmedical.org)
Marshfield Clinic - Ladysmith Center Ladysmith, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Clinic-Chippewa Center Chippewa Falls, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Clinic-Minocqua Center Minocqua, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Clinic-Wausau Center Wausau, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center - Neillsville Neillsville, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center - Weston Weston, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-EC Cancer Center Eau Claire, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Marshfield Marshfield, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-Rice Lake Rice Lake, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Marshfield Medical Center-River Region at Stevens Point Stevens Point, Wisconsin Site Public Contact - (oncology.clinical.trials@marshfieldresearch.org)
Mayo Clinic in Florida Jacksonville, Florida
Mayo Clinic in Rochester Rochester, Minnesota
Medical Oncology and Hematology Associates-West Des Moines Clive, Iowa
Memorial Hospital of Carbondale Carbondale, Illinois Site Public Contact - (clinical.research@sih.net)
Memorial Medical Center Modesto, California Site Public Contact - (pallante.beth@mhsil.com)
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NS-089/NCNP-02-201 in Boys With Duchenne Muscular Dystrophy (DMD)

Trial info - trialinfo@nspharma.com

NCT05996003
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Inclusion Criteria:
* Male ≥ 4 years and \<15 years of age * Confirmed DMD mutation(s) in the dystrophin gene that is amenable to skipping of exon 44 to restore the dystrophin mRNA reading frame * Able to walk independently without assistive devices * Ability to complete the TTSTAND without assistance in \<20 seconds * Stable dose of glucocorticoid for at least 3 months and the dose is expected to remain on a stable dose for the duration of the study. * Other inclusion criteria may apply.
Exclusion Criteria:
* Has a body weight of \<20 kg at the time of informed consent (applies to participants screening for Part 1 only) * Evidence of symptomatic cardiomyopathy * Current or previous treatment with anabolic steroids (e.g., oxandrolone) or products containing resveratrol or adenosine triphosphate within 3 months prior to first dose of study drug * Current or previous treatment with any other investigational drug within 3 months prior to the first dose of study drug or within 5 times the half-life of a medication, whichever is longer * Surgery within the 3 months prior to the first dose of study drug or planned during the study duration * Previously treated in an interventional study of NS-089/NCNP-02 * Having taken any gene therapy. * Having received exon skipping oligonucleotide within 1 year prior to the first dose of IP or is expected to receive exon skipping oligonucleotide prior to completion of study. * Other exclusion criteria may apply.
DRUG: NS-089/NCNP-02
Duchenne Muscular Dystrophy, Exon 44, DMD
Exon 44 Skipping, DMD
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Study Locations

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Location Contacts
Alberta Children's Hospital Calgary, Alberta Julie Dao - (julie.dao@ucalgary.ca)
Ann and Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois Raven Hill - (rhill@luriechildrens.org) Alka Maheshwari - (amaheshwari@luriechildrens.org)
British Columbia Children's Hospital Vancouver, British Columbia Gabe Massarotto - (gabe.massarotto@cw.bc.ca)
Children's Hospital Colorado Aurora, Colorado Hannah Kleiner - (hannah.kleiner@childrenscolorado.org)
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio Angela Edmondson - (Angela.Edmondson@cchmc.org)
Fukui Prefectural Hospital Fukui-shi, Fukui
London Health Sciences Centre London, Teresa Longfield - (teresa.longfield@lhsc.on.ca)
NHO Osaka Toneyama Medical Center Toyonaka, Osaka Clinical Trial Office - (410-chiken@mail.hosp.go.jp)
National Center of Neurology and Psychiatry Kodaira, Tokyo
National Hospital Organization Nagara Medical Center Nagara, Gifu-shi, Gifu Clinical Trial Management Office - (yonekura.kei.wu@mail.hosp.go.jp)
Pusan National University Yangsan Hospital Yangsan, JaeYoon Kim - (lusterwuzz@naver.com)
Rare Disease Research Atlanta, Georgia Julia Zhu - (julia.zhu@rarediseaseresearch.com)
Rare Disease Research, LLC - FL Kissimmee, Florida Marcial Almaraz - (marcial.almaraz@rarediseaseresearch.com)
Seoul National University Hospital Seoul, Hyeon Ju Kwon - (hjkwon@snuh.org; 49041@snuh.org)
Shiga General Hospital Moriyama-shi, Shiga Children's Building - (kenji.s.address@gmail.com)
Starship Children's Hospital Grafton, Auckland Margaret Joppa - (mjoppa@adhb.govt.nz)
The Children's Hospital of Philadelphia (CHOP) Philadelphia, Pennsylvania Karen Monono - (mononok@email.chop.edu)
UT Southwestern/Children's Health Dallas, Texas Deniece Winston - (Deniece.Winston@UTSouthwestern.edu)
University of Kansas Medical Center (KUMC) Kansas City, Kansas Rebecca Clay - (rclay@kumc.edu)
University of Pittsburgh School of Medicine Pittsburgh, Pennsylvania Vibha Chauhan - (vibha.chauhan@chp.edu)
Virginia Commonwealth University Health System Richmond, Virginia Andrea Jewell - (andrea.jewell@vcuhealth.org)
Yeditepe University Kosuyolu Hospital Istanbul, Onur Güner - (onurguner@ascotscience.com)

Advancing Water Security: A Community Participatory School-Based Hydration Intervention

Sarah Farthing, MS - sarah.malone@vcuhealth.org

Melanie Bean
NCT06714929
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Inclusion Criteria:
* Lunchroom observations: All students (K-5th \[Pre-Kindergarten if applicable\]) who eat lunch in the cafeteria on assessment days are eligible * BMI and dental caries assessments: 1) student enrolls in study while in 3rd grade (followed through 5th g) * Student surveys: Students in 4th-5th grade are eligible to complete surveys assessing beverage intake and perceptions of hydration practices within their school district. * Staff surveys: All staff in the target schools will be eligible to complete the Personnel Survey.
Exclusion Criteria:
* Lunchroom observations: None. * BMI and dental caries assessments: Students are ineligible if they are unable to complete assessments due to developmental or physical reasons, 2) planning to move in the study duration * Student surveys: None. * Staff surveys: None.
BEHAVIORAL: Hydration
Dental Caries, Obesity Prevention
hydration, water, sugar-sweetened beverages, dental caries, overweight and obesity
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Study Locations

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Children's Hospital of Richmond at VCU Healthy Lifestyles Center Henrico, Virginia Sarah M Farthing, MS - (sarah.malone@vcuhealth.org) Melanie K Bean, PhD - (melanie.bean@vcuhealth.org)

Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD

Joseph T Hull, PhD - jhull@supernus.com

NCT04781140
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Inclusion Criteria:

• Is male or female 4 years 0 months of age to less than or equal to 5 years 9 months of age at Visit 1 (Screening) and considered medically healthy.
• Subject's parent(s) or legal guardian(s)/representative(s) is (are) willing and able to provide written informed consent before completing any study related procedures.
• Has a primary diagnosis of ADHD according to DSM-IV-TR criteria and confirmed with the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL).
• Has an ADHD-RS-IV-P Total Score of ≥ 28 (males) or ≥ 24 (females) at Visit 1 (Screening) and at Visit 2 (Baseline).
• Has a CGI-S score of ≥ 4 (moderate or worse) at Visit 1 (Screening) and at Visit 2 (Baseline).
• Has undergone an adequate course of non-pharmacologic treatment or is having symptoms severe enough to warrant pharmacologic treatment without prior non-pharmacologic treatment.
• Is participating in a structured group activity (e.g., preschool, kindergarten, sports, Sunday school, summer camp or childcare program) at least 2 days a week during study so as to assess symptoms and impairment in a setting outside the home.
• Has not initiated any behavioral intervention/therapy within 30 days of Visit 1 (Screening) and does not plan to initiate any new or discontinue any ongoing behavioral intervention/therapy during the study (e.g., subject is eligible if behavioral intervention/therapy is initiated 30 or more days prior to Visit 1 \[Screening\] and continues with a similar duration/frequency throughout their study).
• Subjects who are on ADHD medication at Visit 1 (Screening), but whose ADHD symptoms are not well controlled on current ADHD medication (e.g., meets Inclusion Criterion #4), meet all other inclusion/exclusion criteria, and discontinues ADHD medication at least 7 days prior to the day of Visit 2 (Baseline) are eligible to participate.
• Has no current condition in the opinion of the Investigator that could confound efficacy assessments, safety assessments or increase participant risk.
• Has lived with the same parent(s) or legal guardian(s) or has lived under a shared living arrangement (e.g., joint legal custody) for greater than or equal to 6 months prior to Visit 1 (Screening).
• Has a body weight ≥5th percentile for age and sex at Visit 1 (Screening) and Visit 2 (Baseline).
Exclusion Criteria:

• Has a diagnosis at Screening (per K-SADS-PL) of another psychiatric disorder that is considered to be the primary diagnosis rather than ADHD or has a comorbid psychiatric disorder secondary to ADHD that, in the opinion of the investigator (after consulting medical monitor), will likely interfere with study treatment adherence and/or impact study results.
• Has a current diagnosis of a major neurological disorder. The eligibility of those who have seizures, a history of seizure-like events (e.g., syncope, myoclonus, severe muscle spasms), a family history of seizure disorder (immediate family, i.e., sibling, parent), and/or febrile seizures will be assessed on a case-by-case basis after consulting the medical monitor.
• History of Bipolar Disorder diagnosed in a first degree relative.
• Has global development delay or intellectual disability by medical history.
• Has a current diagnosis of a significant (per Investigator's evaluation and/or judgement) systemic disease.
• Has body mass index \> 95th percentile for the subject's age and sex at Visit 1 (Screening) or Visit 2 (Baseline).
• Has a mean resting systolic and diastolic blood pressure\* that are both \>95th percentile for age sex, and height and has a mean resting pulse rate\* that is \>95th percentile for age and sex (males: \>117 bpm; females: \>122 bpm) at Visit 1 (Screening) or Visit 2 (Baseline). \* Note: The mean of three measurements while seated.
• Has a clinically significant electrocardiogram finding(s) at Visit 1 (Screening).
• Is currently taking SPN-812 for ADHD, has previously taken SPN-812 for ADHD, but discontinued due to a lack of efficacy or adverse reactions, or has history of allergic reaction, hypersensitivity or intolerance to viloxazine.
• Has an allergy to or cannot swallow pudding and applesauce and cannot swallow intact capsule whole.
• Has any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the subject's participation in the study.
• Has received any investigational drug within the longer of 30 days or 5 half-lives prior to Visit 2 (e.g., first dose of study medication).
• Has a positive urine drug test at Visit 1 (Screening). A positive test for amphetamines is allowed for subjects receiving a stimulant ADHD medication at Screening. The subject will be required to discontinue the stimulant for the duration of the study, beginning at least 7 days prior to Visit 2 (Baseline).
• Is using of prohibited concomitant medications including known CYP1A2 substrates (e.g., theophylline, melatonin) during the Screening Period or (anticipated) for the duration of the study.
• Any reason that, in the opinion of the Investigator, would prevent the subject from participating in the study.
• Has suicidal ideation ("Yes" indicated on C-SSRS question 4 or 5) or suicidal behavior ("Yes" indicated on C-SSRS for any suicidal behavior) within 6 months prior to or the day of Visit 1 (Screening) or has attempted suicide ("Yes" indicated on C-SSRS for lifetime).
DRUG: 100mg SPN-812, DRUG: Placebo
Attention-Deficit/Hyperactivity Disorder
ADHD
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AIM Trials, LLC Plano, Texas - (info@aimtrials.com)
APG Research LLC Orlando, Florida - (kkenworthyapg@gmail.com)
Advanced Discovery Research LLC Atlanta, Georgia - (contact@advdiscovery.com)
Advanced Research Center (ARC), Inc. Anaheim, California - (contact@arctrials.com)
Alliance Research Long Beach, California - (Research@asclepes.com)
Avantis Clinical Research LLC Miami, Florida - (info@avantisclinicalresearch.com)
Boston Children's Hospital Boston, Massachusetts - (leslie.smitley@childrens.harvard.edu)
CenExcel iResearch, LLC Decatur, Georgia
CenExel iResearch, LLC. Savannah, Georgia
Cincinnati Children's Hospital and Medical Center Cincinnati, Ohio - (ADHDResearch@cchmc.org)
CincyScience West Chester, Ohio - (research@cincyscience.com)
Clinical Integrative Research Center of Atlanta Atlanta, Georgia
Clinical NeuroScience Solutions, Inc. Memphis, Tennessee
Clinical NeuroScience Solutions, Inc. Memphis, Tennessee - (orlinfo@cnshealthcare.com)
Clinical NeuroScience Solutions, Inc. Memphis, Tennessee
Clinical Research Partners, LLC Petersburg, Virginia
Clinical Research of Southern Nevada, LLC. Las Vegas, Nevada - (kluna.cpbm@gmail.com)
Coastal Carolina Research Center North Charleston, South Carolina - (CCRC@CoastalCarolinaResearch.com)
Coastal Pediatric Research Summerville, South Carolina - (info.research@cpakids.com)
Cyn3rgy Research Gresham, Oregon - (support@cyn3rgy.com)
D&H Tamarac Research Center Tamarac, Florida - (info@dhnrc.com)
DelRicht Research Prairieville, Louisiana - (info@delricht.com)
DelRicht Research (Touro Medical Center) New Orleans, Louisiana - (info@delricht.com)
Duke University Durham, North Carolina
Family Psych of The Woodlands The Woodlands, Texas - (info@woodlandspsych.com)
Hope Research Network, LLC. Miami, Florida - (info@hoperesearchnetwork.com)
Houston Clinical Trials, LLC. Bellaire, Texas
IMMUNOe Research Centers Centennial, Colorado - (verosinfo@veroshealth.com)
Icahn School of Medicine at Mount Sinai New York, New York - (adhd.research@mssm.edu)
Javara Dallas, Texas
Jersey Shore University Medical Center Neptune City, New Jersey - (andrew.layman@hmhn.org)
Kennedy Krieger Institute Baltimore, Maryland
Kentucky Pediatric/Adult Research Bardstown, Kentucky - (kpar@kpar.us)
Luna Research Center Coral Gables, Florida
Med Clinical Research Irvington, New Jersey - (info@medclinicalresearch.com)
Medical Research Group of Central Florida Orange City, Florida
Neurobehavioral Medicine Group Bloomfield Hills, Michigan - (info@neurobmg.com)
Pediatric Neurology and Epilepsy Specialists Winter Park, Florida - (ARiveraDelValle@pediatricneurologyandepilepsy.com) - (DHubert@pediatricneurologyandepilepsy.com)
Penn State Health Medical Group - Psychiatry and Behavioral Health Hershey, Pennsylvania - (crobel@pennstatehealth.psu.edu)
Precise Research Centers Flowood, Mississippi
Preferred Research Partners, Inc. Little Rock, Arkansas - (info@preferredresearchpartners.com)
Qualmedica Research, LLC. Owensboro, Kentucky
Qualmedica Research, LLC. Owensboro, Kentucky
Sarkis Clinical Trials Gainesville, Florida
Sun Valley Research Center Imperial, California - (svrcinfo@sunvalleyb.com)
The Center for Clinical Trials, Inc. Saraland, Alabama - (info@thecenterforclinicaltrials.com)
Virginia Commonwealth University, Virginia Treatment Center for Children Richmond, Virginia

HCRN Endoscopic Versus Shunt Treatment of Hydrocephalus in Infants (ESTHI)

Nichol Nunn - nichol.nunn@hsc.utah.edu

NCT04177914
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Inclusion Criteria:

• Corrected age \<104 weeks and 0 days, AND
• Child is ≥ 37 weeks post menstrual age, AND
• Child must have symptomatic hydrocephalus, defined as: Ventriculomegaly on MRI (frontal-occipital horn ratio (FOR) \>0.45, which approximates "moderate ventriculomegaly"), and at least one of the following: * Head circumference \>98th percentile for corrected age with either bulging fontanelle or splayed sutures * Upgaze paresis/palsy (sundowning) * CSF leak * Papilledema * Tense pseudomeningocele or tense fluid along a track * Vomiting or irritability, with no other attributable cause * Bradycardias or apneas, with no other attributable cause * Intracranial pressure (ICP) monitoring showing persistent elevation of pressure with or without plateau waves AND
• No prior history of shunt insertion or endoscopic third ventriculostomy (ETV) procedure (previous temporization devices and/or external ventricular drains permissible)
Exclusion Criteria:

• Hydrocephalus due to intraventricular hemorrhage in a child born before 37 weeks gestational age; OR
• Anatomy not suitable for ETV+CPC or anteriorly placed ventriculoperitoneal shunt defined as: * Moderate to severe prepontine adhesions on steady state free precession (SSFP) or T2 weighted fast (turbo) spin echo (FSE/TSE) MRI, which includes the following sequences: FIESTA, FIESTA-C, TrueFISP, CISS, Balanced FFE (bFFE), CUBE, SPACE, VISTA, IsoFSE, and 3D MVOX * Closure of one or both foramina of Monro * Thick floor of third ventricle (≥ 3mm) * Narrow third ventricle (\<5mm) * Presence of scalp, bone, or ventricular lesions that make placement of an anterior shunt impracticable; OR
• Underlying condition with a high chance of mortality within 12 months; OR
• Hydrocephalus with loculated CSF compartments; OR
• Peritoneal cavity not suitable for distal shunt placement; OR
• Active CSF infection; OR
• Hydranencephaly; OR
• Child requires an intraventricular procedure (e.g. endoscopic biopsy) in addition to the initial first-time permanent procedure for the treatment of hydrocephalus.
PROCEDURE: Endoscopic Third Ventriculostomy with Choroid Plexus Cauterization (ETV+CPC), DEVICE: Ventriculoperitoneal Shunt
Hydrocephalus
Hydrocephalus, Infants, Ventriculoperitoneal Shunt, ETV+CPC, endoscopic third ventriculostomy, choroid plexus cauterization
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Alberta Children's Hospital Calgary, Alberta Ruksana Rashid, MBBS MPH MSc - (rsrashid@ucalgary.ca)
Arnold Palmer Hospital for Children Orlando, Florida Richard Guerrero - (richard.guerrero@orlandohealth.com)
British Columbia Children's Hospital Vancouver, British Columbia Annika Weirs - (annika.weir@cw.bc.ca)
Children's Hospital Colorado Aurora, Colorado Susan Staulcup, 80045 - (SUSAN.STAULCUP@UCDENVER.EDU)
Children's Hospital of Los Angeles Glendale, California Helen Berroya - (hberroya@chla.usc.edu)
Children's Hospital of Pittsburgh of UPMC Pittsburgh, Pennsylvania Kimberly Diamond, BS, BA - (diamondkl@upmc.edu)
Children's Of Alabama Birmingham, Alabama Anastasia Smith, MPH - (Anastasia.Smith@childrensal.org)
Johns Hopkins Children's Center Baltimore, Maryland Sydney White - (swhit128@jh.edu)
Monroe Carell Jr. Children's Hospital at Vanderbilt Nashville, Tennessee Julia Loes - (julia.loes@vumc.org) Stephen Gannon - (stephen.r.gannon@vumc.org)
Nationwide Children's Hospital Columbus, Ohio Jared Haught - (Jared.Haught@nationwidechildrens.org)
Phoenix Children's Hospital Phoenix, Arizona Bethany Norton - (bnorton1@phoenixchildrens.com)
Primary Children's Hospital Salt Lake City, Utah Alli Ludwick - (allison.ludwick@hsc.utah.edu)
Seattle Children's Hospital Seattle, Washington Jessica Becerra - (Jessica.Becerra@seattlechildrens.org)
St. Louis Children's Hospital St Louis, Missouri Diego Morales, MS - (moralesd@wudosis.wustl.edu) Mary Goldschmidt - (goldschmidt@wustl.edu)
Texas Children's Hospital Houston, Texas Edgardo Santisbon - (exsantis@texaschildrens.org)
The Hospital for Sick Children Toronto, Ontario Homa Ashrafpour - (homa.ashrafpour@sickkids.ca)
The Pennsylvania State University University Park, Pennsylvania
Trustees of Indiana University Indianapolis, Indiana Mariah Shirrell - (mkillin@iu.edu)
Virginia Commonwealth University Richmond, Virginia
Wolfson Children's Hospital Jacksonville, Florida Asmaa Hatem - (Asmaa.Hatem@jax.ufl.edu)
Yale University New Haven, Connecticut

Effectiveness of the Eko Digital Stethoscope in Capturing Infant ECGs

Christopher Snyder - christopher.snyder@vcuhealth.org

NCT06382207
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Inclusion Criteria:
* Age \<1 year * No previous diagnosis of arrhythmia * Parent/caregiver can provide informed consent * Parent/caregiver can speak and understand simple English
Exclusion Criteria:
* Age ≥ 1 year * Patient has a pacemaker or implantable cardioverter defibrillator (ICD) * Parent/caregiver is unwilling or unable to provide informed consent * Parent/caregiver is unable to speak and understand English
DEVICE: Eko Duo electronic stethoscope, DEVICE: CORE 500 electronic stethoscope
Tachyarrhythmia
Infant Tachyarrhythmia, Cardiac Rhythm, Digital Stethoscope
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Virginia Commonwealth University Richmond, Virginia Christopher Snyder - (christopher.snyder@vcuhealth.org) Margaret Lessard - (margaret.lessard@vcuhealth.org)

A Study of the Drug Letermovir as Prevention of Cytomegalovirus Infection After Stem Cell Transplant in Pediatric Patients

ctrrecruit@vcu.edu

NCT05711667
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Inclusion Criteria:
* \>= 2 years and \< 18 years at the time of enrollment * Weight must be \>= 18 kg. For patients \< 12 years of age and expected to receive cyclosporine, weight must be \>= 30kg * Planned allogeneic HCT (bone marrow, peripheral blood stem cell, or cord blood transplant) * Patient must be CMV sero-positive (i.e., recipient CMV immunoglobulin G positive) * Patient is eligible for entry only if it is feasible for plasma CMV PCR testing to be sent and resulted within the protocol mandated time period * Reminder: To limit the likelihood of positive plasma CMV PCR post-enrollment and prior to start of study treatment period, it is recommended that patient enrollment proceed after patients start their transplant preparative regimen * Patient must have a performance status corresponding to Lansky/Karnofsky scores \> 50 * Note: Use Lansky for patients =\< 16 years of age and Karnofsky for patients \> 16 years of age. For further reference, see performance status scales scoring under the standard sections for protocols among protocol reference materials provided on the Children's Oncology Group (COG) member website: https://members.childrensoncologygroup.org/prot/reference\_materials.asp * Estimated glomerular filtration rate \> 15 mL/min/1.73 m\^2 and not receiving dialysis * Total bilirubin =\< 2.5 mg/dL and serum glutamate-pyruvate transaminase (SPGT) (alanine transaminase \[ALT\]) =\<10 x upper limit of normal (ULN) for age * Note: For the purpose of this study, the ULN for SGPT (ALT) has been set to the value of 45 U/L
Exclusion Criteria:
* Expected inability to tolerate oral formulation (e.g., unable swallow whole tablets) of letermovir * Note: Determination of ability to tolerate the oral formulation will be based on a self-assessment or caregiver assessment; eligible subjects and their caregiver will be shown a life size picture of a tablet (or actual tablet) and confirm ability to swallow whole tablet in order to meet study eligibility * Hypersensitivity to letermovir or any component of the formulation * History of CMV end organ disease within 6 months (180 days) prior to enrollment * Note: CMV end organ disease based on proposed definitions by Ljungman et al. and inclusive of proven, probable or possible disease * Receipt of prior allogeneic HCT within one year of study enrollment * Planned prophylactic administration of other anti-CMV medications or cellular products during the study, including: * High dose acyclovir (defined as doses \>= 1500 mg/m\^2 IV or \>= 3200 mg oral (patients \>= 40 kg) or \>= 2400 mg/m\^2 (patients \< 40 kg) per day) * High dose valacyclovir (defined as doses \>= 3000 mg/day in patients \> 20 kg) * Foscarnet * Ganciclovir * Valganciclovir * CMV-directed cytotoxic T lymphocytes * Planned receipt of the following contraindicated medications during the study treatment period; contraindicated medications must be discontinued at least 14 days prior to Day +1 * Contraindicated medications for all patients: * Pimozide * Ergot alkaloids * Contraindicated medications for patients planned to receive cyclosporine: * Bosentan * Lovastatin * Pitavastatin * Rosuvastatin * Simvastatin * Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted in certain animal reproduction studies with letermovir. A pregnancy test is required for female patients of childbearing potential * Lactating females who plan to breastfeed their infants * Sexually active female patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their letermovir treatment and through at least 4 weeks after the last dose of letermovir. * Note: No contraception measures are needed specifically during letermovir treatment for male trial participants who have pregnant or non-pregnant female partner(s) of reproductive potential. Contraception measures may be required for other aspects of the HCT procedure. * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
PROCEDURE: Biospecimen Collection, DRUG: Letermovir
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
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Alfred I duPont Hospital for Children Wilmington, Delaware Site Public Contact - (Allison.bruce@nemours.org)
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center Houston, Texas Site Public Contact - (burton@bcm.edu)
Children's Hospital New Orleans New Orleans, Louisiana
Children's Hospital of Alabama Birmingham, Alabama Site Public Contact - (oncologyresearch@peds.uab.edu)
Children's Hospital of Michigan Detroit, Michigan Site Public Contact - (helpdesk@childrensoncologygroup.org)
Children's Hospital of Philadelphia Philadelphia, Pennsylvania Site Public Contact - (CancerTrials@email.chop.edu)
Children's Mercy Hospitals and Clinics Kansas City, Missouri
Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital Grand Rapids, Michigan Site Public Contact - (crcwm-regulatory@crcwm.org)
Johns Hopkins University/Sidney Kimmel Cancer Center Baltimore, Maryland Site Public Contact - (jhcccro@jhmi.edu)
Medical City Dallas Hospital Dallas, Texas
Methodist Children's Hospital of South Texas San Antonio, Texas Site Public Contact - (Vinod.GidvaniDiaz@hcahealthcare.com)
Nemours Children's Clinic-Jacksonville Jacksonville, Florida Site Public Contact - (Allison.bruce@nemours.org)
Norton Children's Hospital Louisville, Kentucky Site Public Contact - (CancerResource@nortonhealthcare.org)
Primary Children's Hospital Salt Lake City, Utah
Saint Jude Children's Research Hospital Memphis, Tennessee Site Public Contact - (referralinfo@stjude.org)
The Children's Hospital at TriStar Centennial Nashville, Tennessee
UCSF Benioff Children's Hospital Oakland Oakland, California Site Public Contact - (PedOncRschOAK@ucsf.edu)
UCSF Medical Center-Mission Bay San Francisco, California Site Public Contact - (cancertrials@ucsf.edu)
UT Southwestern/Simmons Cancer Center-Dallas Dallas, Texas Site Public Contact - (canceranswerline@UTSouthwestern.edu)
University of Iowa/Holden Comprehensive Cancer Center Iowa City, Iowa
University of Wisconsin Carbone Cancer Center - University Hospital Madison, Wisconsin Site Public Contact - (clinicaltrials@cancer.wisc.edu)
VCU Massey Comprehensive Cancer Center Richmond, Virginia Site Public Contact - (CTOclinops@vcu.edu)

A Research Study to Advance the CF Therapeutics Pipeline for People Without Modulators

Olena Boyarska - olena.boyarska@seattlechildrens.org

NCT06504589
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Consent A. Written informed consent (and assent when applicable) obtained from participant or participant's legal guardian B. Is willing and able to adhere to the study visit schedule and other protocol requirements Demographics A. ≥ 12 years of age at Visit 1 Medical History A. For persons of child-bearing potential: must not be pregnant at Visit 1 or plan to get pregnant during the 12-month study period Disease History A. Documentation of a CF diagnosis as evidenced by one or more clinical features consistent with the CF phenotype and one or more of the following criteria: * Sweat chloride ≥ 60 mEq/liter by quantitative pilocarpine iontophoresis test (QPIT) * Two well-characterized disease-causing pathogenic variants in the CFTR gene or * One well-characterized disease-causing mutation and a second CFTR variant (with variable or uncharacterized disease-causing potential) and sweat ≥ 30 mmol/liter with permission of the study sponsor-investigators B. Clinically stable with no significant changes in health status within the 28 days prior to and including Visit 1 C. Does not have a history of lung transplantation Concomitant Medications A. Not genetically eligible for a CFTR modulator according to product label indications and/or No use of CFTR modulator for 28 days prior to Visit 1 with no intent to start or restart during the study period B. No use of an investigational drug within 90 days prior to and including Visit 1 C. Not currently participating in an interventional drug or device trial. Participation in long-term safety follow-up studies (without redosing) and/or behavioral intervention trials is allowed. D. No initiation of new chronic therapy (e.g., ibuprofen, azithromycin, inhaled tobramycin, Cayston®) within 28 days prior to and including Visit 1 E. No acute use of antibiotics (oral, inhaled or IV) or acute use of systemic corticosteroids for respiratory tract symptoms within 28 days prior to and including Visit 1
Cystic Fibrosis
ineligible and/or not taking CFTR modulators, People with CF
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Adult Cystic Fibrosis Center at the University of Utah Salt Lake City, Utah Kristyn Packer - (kristyn.packer@hsc.utah.edu)
Atrium Health Wake Forest Baptist Charlotte, North Carolina Anna Pippins - (apippins@wakehealth.edu)
Augusta University Augusta, Georgia Heidi Stapp - (hstapp@augusta.edu)
Baylor College of Medicine Houston, Texas Tracy Mosely - (tlmosely@texaschildrens.org)
Billings Clinic Billings, Montana Jerimiah Lysinger - (JLysinger@billingsclinic.org)
Boston Children's Hospital Boston, Massachusetts Robert Fowler - (Robert.fowler@childrens.harvard.edu)
Central Florida Pulmonary Group Altamonte Springs, Florida Desiree Serr - (dserr@cfpulmonary.com)
Children's Healthcare of Atlanta and Emory University Atlanta, Georgia Ashleigh Streby - (ashleigh.streby@emory.edu)
Children's Hospital Colorado Aurora, Colorado Mary Cross - (mary.cross@childrenscolorado.org)
Children's Hospital of Philadelphia Philadelphia, Pennsylvania Erin Donnelly - (Donnellye4@email.chop.edu)
Childrens Hospital Los Angeles Los Angeles, California Carmen Reyes - (mareyes@chla.usc.edu)
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio Kelly Thornton - (Kelly.Thornton@cchmc.org)
Cleveland Clinic Cystic Fibrosis Program Cleveland, Ohio Dave Weaver - (weaverd@ccf.org)
Cohen Children's Medical Center of New York New Hyde, New York Susan Galvin - (sgalvin@northwell.edu)
Columbia University Cystic Fibrosis Program New York, New York Emily DiMango - (ead3@cumc.columbia.edu)
Cook Children's Medical Center Fort Worth, Texas Anna Reyes - (anna.reyes@cookchildrens.org)
Corewell Health Helen DeVos Grand Rapids, Michigan Alicia Castillo Bahena - (alicia.castillobahena@corewellhealth.org)
Dayton Children's Hospital Dayton, Ohio Amy Jones - (Jonesa11@childrensdayton.org)
Dell Children's Medical Center of Central Texas Austin, Texas Kristina "Tina" Adrean - (Kadrean@ascension.org)
Hershey Medical Center Pennsylvania State University Hershey, Pennsylvania Diane M Kitch - (dkitch@pennstatehealth.psu.edu)
Inova L.J. Murphy Pediatric CF Program Fairfax, Virginia Colleen Mann - (colleen.mann@inova.org)
John Hopkins Hospital Baltimore, Maryland Jeanne Pinto - (jpinto4@jh.edu)
Massachusetts General Hospital Boston, Massachusetts Margot Hardcastle - (mhardcastle@mgh.harvard.edu)
Medical University of South Carolina Charleston, South Carolina Ashley Warden - (jonesash@musc.edu)
Morristown Medical Center Morristown, New Jersey Debra Connolly - (Debra.Connolly@atlantichealth.org)
National Jewish Health Denver, Colorado Alix Wilson - (wilsona@njhealth.org)
Nationwide Children's Hospital Columbus, Ohio Diana Gilmore - (Diana.Gilmore@nationwidechildrens.org)
New York Medical College at Westchester Medical Center Valhalla, New York Zachary Messer - (Zachary_Messer@nymc.edu)
Northwestern University Chicago, Illinois Rachel Nelson - (rachel.nelson@northwestern.edu)
Oregon Health & Sciences University Portland, Oregon Jenna Bucher - (bucherj@ohsu.edu)
Phoenix Children's Hospital Phoenix, Arizona Natalia Argel - (Nargel@phoenixchildrens.com)
Prisma Health Children's Hospital - Midlands Columbia, South Carolina Veronica Lipscomb - (Veronica.Lipscomb@PrismaHealth.org)
Providence Medical Group, Cystic Fibrosis Clinic Spokane, Washington Joan Milton - (joan.milton@providence.org)
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center Cleveland, Ohio Primary RC & Participant Contact General Contact - (RainbowCFResearch@UHhospitals.org)
Riley Hospital for Children Indianapolis, Indiana Lisa Bendy - (lbendy@iupui.edu)
Saint Luke's Cystic Fibrosis Center of Idaho Boise, Idaho Lejla Godusevic - (godusevl@slhs.org)
Seattle Children's Hospital Seattle, Washington Sharon McNamara - (sharon.mcnamara@seattlechildrens.org)
Stanford University Medical Center Stanford, California Jacquelyn Spano - (jmzirbes@stanford.edu)
Tampa General Hospital Tampa, Florida Andrew Marino - (armarino@usf.edu)
The Children's Hospital Alabama, University of Alabama at Birmingham Birmingham, Alabama Kathryn Monroe - (kathrynmonroe@uabmc.edu)
The Cystic Fibrosis Center of Western New York Buffalo, New York Julianne Hergenroder - (jhergenroder@upa.chob.edu)
The Minnesota Cystic Fibrosis Center Minneapolis, Minnesota CF Trials Contact University of Minnesota, Participant Contact - (cftrials@umn.edu)
Tucson Cystic Fibrosis Center Tucson, Arizona Elizabeth Ryan - (elizabethryan@email.arizona.edu)
Tulane University New Orleans, Louisiana Adrienne Savant - (asavant1@tulane.edu)
University of Arkansas for Medical Sciences Little Rock, Arkansas Kathleen Hicks - (HicksKathleenT@uams.edu)
University of California San Diego San Diego, California Jenna Mielke - (jmielke@health.ucsd.edu)
University of California, San Francisco - Adult Center San Francisco, California Courtney Moreno - (Courtney.Moreno@ucsf.edu)
University of California, San Francisco - Peds Center San Francisco, California Ngoc Ly - (Ngoc.Ly@ucsf.edu)
University of Florida Gainesville, Florida Chrystal Bailey - (Cbailey1@peds.ufl.edu)
University of Kansas Medical Center Kansas City, Kansas Lawrence Scott - (lscott2@kumc.edu)
University of Kentucky Lexington, Kentucky Chase Whitaker - (chase.whitaker@uky.edu)
University of Massachusetts Memorial Health Care Worcester, Massachusetts Jaclyn Longtine - (Jaclyn.Longtine@umassmed.edu)
University of Miami Miami, Florida Ylber (Ivan) Whitaker - (yiw2@miami.edu)
University of Michigan, Michigan Medicine Ann Arbor, Michigan Dawn Kruse - (dmkruse@med.umich.edu)
University of Nebraska Medical Center Omaha, Nebraska Michel Veit - (michel.veit@unmc.edu)
University of North Carolina at Chapel Hill Chapel Hill, North Carolina Julie Goudy - (julie_goudy@med.unc.edu)
University of Pennsylvania Philadelphia, Pennsylvania Melissa Molter - (melissa.molter@pennmedicine.upenn.edu)
University of Pittsburgh Medical Center Pittsburgh, Pennsylvania Adrienne DeRicco - (adrienne.dericco2@upmc.edu)
University of Rochester Medical Center Strong Memorial Rochester, New York Barb Johnson - (Barbara_Johnson@URMC.Rochester.edu)
University of Texas Southwestern Dallas, Texas Ashley Keller - (Ashley.Keller@UTSouthwestern.edu)
University of Texas Southwestern / Children's Health Dallas, Texas Keianna Brown - (Keianna.brown@utsouthwestern.edu)
University of Washington Medical Center Seattle, Washington Lauren Bartlett - (lrejman@uw.edu)
University of Wisconsin Madison, Wisconsin Melanie Nelson - (mnelson@pediatrics.wisc.edu)
Vanderbilt University Medical Center Nashville, Tennessee Brijesh Patel - (brijesh.patel@vumc.org)
Virginia Commonwealth University Richmond, Virginia Akilah Pierre-Louis - (akilah.pierrelouis1@vcuhealth.org)
Washington University School of Medicine St Louis, Missouri Irma Bauer - (irmabauer@wustl.edu)
Wayne State University Harper University Hospital Detroit, Michigan Debra Driscoll - (ddriscol@med.wayne.edu)
West Virginia University - Morgantown Morgantown, West Virginia Tammy Clark - (tclark@hsc.wvu.edu)

A Study of Repotrectinib in Pediatric and Young Adult Subjects Harboring ALK, ROS1, OR NTRK1-3 Alterations

BMS Study Connect Contact Center www.BMSStudyConnect.com - Clinical.Trials@bms.com

NCT04094610
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Key
Inclusion Criteria:

• Documented genetic ROS1 point mutation, fusion, or amplification or NTRK1-3 fusion as identified by local testing in a Clinical Laboratory Improvement Amendments (CLIA) laboratory in the US or equivalently accredited diagnostic lab outside the United States (US) is required.
• Phase 1: Age \<12 years; Phase 2: Age 12- 25 years
• Prior cytotoxic chemotherapy is allowed.
• Prior immunotherapy is allowed.
• Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1.
• All subjects must have measurable disease by RECIST v1.1 or Response Assessment in Neuro-Oncology (RANO) criteria at time of enrollment.
• Subjects with a primary CNS tumor or CNS metastases must be neurologically stable on a stable or decreasing dose of steroids for at least 7 days prior to enrollment.
• Subjects must have a Lansky (\< 16 years) or Karnofsky (≥ 16 years) score of at least 50.
• Life expectancy greater than or equal to 12 weeks, in the investigator's opinion.
• Adequate hematologic, renal and hepatic function. Phase 2
Inclusion Criteria:

• Cohort Specific
Inclusion Criteria:
* Cohort 1: Subjects with NTRK fusion gene positive (NTRK+) advanced solid tumors (including primary CNS tumors), that are tropomyosin receptor kinase (TRK) TKI naïve; * Cohort 2: subjects with NTRK+ advanced solid tumors (including primary CNS tumors), that are TRK TKI pre-treated; * Cohort 3: subjects with advanced solid tumors with ROS1 gene fusions or other ROS1 aberrations (including amplifications and point mutations) with measurable disease.
• Subjects in Cohorts 1 and 2 must have prospectively confirmed measurable disease by BICR prior to enrollment. Key Exclusion Criteria (Phase 1 and Phase 2):
• Subjects with neuroblastoma with only bone marrow disease evaluable by bone marrow aspiration only.
• Major surgery within 14 days (2 weeks) of start of repotrectinib treatment. Central venous access (Broviac, Mediport, etc.) placement does not meet criteria for major surgery.
• Known active infections requiring ongoing treatment (bacterial, fungal, viral including HIV positivity).
• Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption.
• Any of the following cardiac criteria: * Mean resting corrected QT interval (ECG interval measured from the onset of the QRS complex to the end of the T wave) for heart rate (QTc) \> 480 msec obtained from three ECGs, using the screening clinic ECG machine-derived QTc value * Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG (e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \> 250 msec) * Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, congenital long QT syndrome, family history of long QT syndrome, or any concomitant medication known to prolong the QT interval
• Peripheral neuropathy of CTCAE ≥grade 2.
• Subjects being treated with or anticipating the need for treatment with strong CYP3A4 inhibitors or inducers.
• Any potential allergies to repotrectinib and/or its excipients.
DRUG: Oral repotrectinib (TPX-0005)
Locally Advanced Solid Tumors, Metastatic Solid Tumors, Lymphoma, Primary CNS Tumors
ALK, ROS1, NTRK1-3, Primary CNS tumor, anaplastic large cell lymphoma, metastatic solid tumor, advanced solid tumor, sarcoma, infantile fibrosarcoma, glioblastoma, soft tissue schwannoma, solitary fibrous tumor, glioma, inflammatory myofibroblastic tumor, pediatric
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Alder Hey Children's NHS Foundation Trust Liverpool, England
Asan Medical Center Seoul,
Baylor College of Medicine Houston, Texas
Centre Hospitalier Universitaire d'Angers Angers, Maine-et-Loire
Centre Hospitalier Universitaire de Bordeaux - Groupe Hospitalier Pellegrin Bordeaux,
Children's Health Queensland Hospital and Health Service South Brisbane, Queensland
Children's Healthcare of Atlanta - Egleston Hospital Atlanta, Georgia
Children's Hospital Colorado - Anschutz Medical Campus Aurora, Colorado
Children's Hospital Los Angeles Los Angeles, California
Children's Hospital Of Eastern Ontario Ottawa, Ontario
Children's Hospital of Philadelphia-Center for Childhood Cancer Research Philadelphia, Pennsylvania
Children's Hospital of Richmond at VCU Richmond, Virginia
Clinica Universidad de Navarra Madrid,
Clinica Universidad de Navarra Madrid,
Dana Farber Cancer Institute. Boston, Massachusetts
Fondazione IRCCS - Istituto Nazionale dei Tumori Milan,
Great Ormond Street Hospital for Children NHS Foundation Trust London,
HM Sanchinarro University Hospital Madrid,
Hospital Infantil Universitario Nino Jesus Madrid,
Hospital Sant Joan de Deu Barcelona,
Hospital Universitari Vall d'Hebron Barcelona, Barcelona [barcelona]
Hospital Universitario Virgen del Rocio Seville,
Hospital Universitario y Politécnico La Fe Valencia,
Hôpitaux Universitaires de Marseille Timone Marseille,
Institut Gustave-Roussy Villejuif, FR
Institut d Hematologie et d Oncologie Pediatriques Lyon,
KK Women's and Children's Hospital Singapore,
Levine Children's Hospital- Pediatric Neuro-Oncology Charlotte, North Carolina
Local Institution - 2102 New York, New York
Local Institution - 2104 Houston, Texas
Local Institution - 2105 Orlando, Florida
Local Institution - 2110 New Brunswick, New Jersey
Local Institution - 2112 Cleveland, Ohio
Local Institution - 2114 Hershey, Pennsylvania
Local Institution - 2120 Orlando, Florida
Local Institution - 4302 Rome,
Local Institution - 4403 Birmingham,
Local Institution - 6103 Westmead, New South Wales
Local Institution - 6104 Randwick, New South Wales
Local Institution - 6105 Barcelona,
Local Institution - 6106 Madrid,
Local Institution - 6107 Valencia,
Local Institution - 6108 Villejuif,
Local Institution - 6109 Paris,
Local Institution - 6110 Marseille,
Local Institution - 6111 Lyon, Rhone
Local Institution - 6112 Nantes,
Local Institution - 6113 Padua,
Local Institution - 6114 Torino,
Local Institution - 6303 Seoul, Seodaemun-gu
Local Institution - 6304 Seoul,
Maine Medical Center Portland, Maine
National Taiwan University Hospital Taipei,
National University Hospital Singapore,
Perth Childrens Hospital Nedlands, Western Australia
Rigshospitalet - Glostrup Copenhagen,
Royal Hosp. for Children Glasgow,
Seoul National University Hospital Seoul,
St Justine Hospital Montreal, Quebec
St. Jude Children's Research Hospital Memphis, Tennessee
Stollery Children's Hospital Edmonton, Alberta
Taipei Medical University Hospital Taipei,
The Royal Marsden NHS Foundation Trust Sutton,
The University of Texas Southwestern Medical Center - Harold C Simmons Comprehensive Cancer Center Dallas, Texas
University Hospital of Wales Cardiff,
University of Calgary Calgary, Alberta
University of California at Los Angeles Los Angeles, California
Washington University School of Medicine in St. Louis St Louis, Missouri

Research Participation With Transgender and Gender-Diverse Youth

An Pham, MD - an.pham@vcuhealth.org

NCT05927350
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Inclusion Criteria:
* Gender identity different then sex assigned at birth * Between the ages 15-21 years
Exclusion Criteria:
* Gender identity the same as their sex assigned at birth * Younger than 15 years of age, and older than 21 years of age
OTHER: Survey
Transgender Persons
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Virginia Commonwealth University Richmond, Virginia An Pham - (an.pham@vcuhealth.org)

Using Dichoptic Therapy to Treat Intermittent Exotropia

Evan Silverstein - evan.silverstein@vcuhealth.org

NCT06529016
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Inclusion Criteria:
* Diagnosed with IXT * one eye that is their preferred eye * ages 4-7 * distance control scores of \<= 4
Exclusion Criteria:
* distance control scores of 5 * patients with visual acuity with vision that is worse in one eye by greater than two lines * no preferred eye * patients who would be unable to tolerate wearing the headset for 1 hour/day, 6 days/week, for 12 weeks.
DEVICE: Luminopia, a virtual reality headset, OTHER: Paper pre- survey, OTHER: Paper Survey
Exotropia Intermittent
Dichoptic therapy
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Virginia Commonwealth University Richmond, Virginia Evan Silverstein, MD - (evan.silverstein@vcuhealth.org) Emilia Varrone - (emilia.varrone@vcuhealth.org)

Luveltamab Tazevibulin (STRO-002) in Infants and Children < 12 Years of Age with Relapsed/Refractory CBFA2T3::GLIS2 AML

Anna Butturini, MD - CBFGLISAML@sutrobio.com

NCT06679582
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Inclusion Criteria:
* AML with CBFA2T3::GLIS2 gene fusion centrally confirmed * Refractory or relapsed disease with ≥ 5% bone marrow involvement with leukemic blasts by morphology * Age \< 12 years. * Lansky performance of ≥ 50 * Adequate organ functions
Exclusion Criteria:
* Active central nervous system (CNS) disease (CNS3) * Pre-existing clinically significant corneal disorders or constitutional diseases associated with an increased risk of AML treatment toxicities * Active or uncontrolled infections or other active severe intercurrent illnesses, * Prior treatment with a FOLR1- targeting ADCs or with ADCs that contain a tubulin inhibitor * History of allogeneic hematopoietic stem cell transplant or any organ transplant in the prior 84 days * Graft versus host disease (GVHD) of any grade or GVHD treatment with exception of low dose steroids
DRUG: Luveltamab tazevibulin
Acute Myeloid Leukemia (AML)
CBFA2T3::GLIS2 Fusion, CBFA2T3::GLIS2 AML, RAM Phenotype (CD56pos), CD45, CD38, HLA-DR weak or absent), REFRaME, AML, Child, Pediatric AML, Levelatamab, REFRaME-P1
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Location Contacts
Children's Hospital of Philadelphia (CHOP) Philadelphia, Pennsylvania Tasleema Patel, BA - (Patelt6@chop.edu)
Childrens Hospital of Alabama Birmingham, Alabama Bridget Tate, Study Coordinator - (pedsCTO@uabmc.edu)
Childrens National Hospital Washington D.C., District of Columbia Kristen Brown, Study Coordinator - (DVL@childrensnational.org)
VCU Massey Cancer Center-Adult Outpatient Pavillion Richmond, Virginia Lindsey Gwaltney, Study Coordinator - (lbgwaltney@vcu.edu)

ARDS in Children and ECMO Initiation Strategies Impact on Neurodevelopment (ASCEND) (ASCEND)

Kelli McDonough, MS - kellimcd@umich.edu

NCT05388708
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Inclusion Criteria:
* Time between intubation and ECMO cannulation is less than 240 hours (10 days) * ECMO support type is respiratory (VV or VA cannulation) * Chest radiograph with bilateral lung disease * Moderate or severe pediatric ARDS as measured by oxygenation index or oxygen saturation index after intubation and prior to ECMO cannulation: One OI ≥ 16 or Two OIs ≥ 12 and ≤ 16 at least four hours apart or Two OSIs ≥ 10 at least four hours apart or One OI ≥ 12 and ≤ 16 and One OSI ≥ 10 at least four hours apart
Exclusion Criteria:
* Previously enrolled in PROSpect * Perinatal related lung disease * Congenital diaphragmatic hernia or congenital/acquired diaphragm paralysis * Respiratory failure caused by cardiac failure or fluid overload * Cyanotic congenital heart disease * Cardiomyopathy * Primary pulmonary hypertension (PAH) * Unilateral lung disease * Intubated for status asthmaticus * Obstructive airway disease * Bronchiolitis obliterans * Post hematopoietic stem cell transplant * Post lung transplant * Home ventilator dependent * Neuromuscular respiratory failure * Head trauma: (managed with hyperventilation) * Intracranial bleeding * Unstable spine, femur or pelvic fractures * Acute abdominal process/open abdomen * Family/medical team have decided to not provide full support * Enrolled in interventional clinical trial: not approved for co-enrollment; does not include cancer protocols. * Known pregnancy
DEVICE: ECMO support, OTHER: PROSpect protocolized therapies
Acute Respiratory Distress Syndrome, Extracorporeal Membrane Oxygenation
ARDS, Acute Respiratory Distress Syndrome, Extracorporeal Membrane Oxygenation, ECMO, Extracorporeal Life Support, ECLS, Pediatric, Quality of Life, Functional Status
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Location Contacts
Akron Children's Hospital Akron, Ohio Patricia Raimer, MD - (PRaimer@akronchildrens.org)
Alder Hey Children's Hospital Liverpool, Marie Horan - (marie.horan@alderhey.nhs.uk)
Ann & Robert H. Lurie Children's Hospital of Chicago Chicago, Illinois Bria Coates, MD - (b-coates@northwestern.edu)
Arkansas Children's Hospital Little Rock, Arkansas Matthew Malone, MD - (MPMalone@uams.edu)
Atrium Health Wake Forest Baptist | Brenner Children's Hospital Winston-Salem, North Carolina Alan Woodruff, MD - (agwoodru@wakehealth.edu)
Boston Children's Hospital Boston, Massachusetts Sally Vitali, MD - (Sally.Vitali@childrens.harvard.edu)
Cardinal Glennon Children's Hospital St Louis, Missouri Erik Madsen, MD - (erik.madsen@ssmhealth.com)
Children's Healthcare of Atlanta Atlanta, Georgia Heather Viamonte, MD - (heather.chandler@choa.org)
Children's Hospital Colorado Aurora, Colorado John Kim, MD - (John.Kim@childrenscolorado.org)
Children's Hospital and Vall d' Hebron Women's Hospital Barcelona, Joan Balcells Ramirez - (joanbalcells@me.com)
Children's Hospital of Michigan Detroit, Michigan Mina Hafzala, MD - (MHafzala@dmc.org)
Children's Hospital of Orange County Orange, California Adam Schwarz, MD - (ASchwarz@choc.org)
Children's Hospital of Philadelphia Philadelphia, Pennsylvania Adam Himebaugh, MD - (himebaugha@chop.edu)
Children's Hospital of Richmond at VCU Richmond, Virginia
Children's Medical Center Dallas Dallas, Texas Archana Dhar, MD - (archana.dhar@UTSouthwestern.edu)
Children's Memorial Hermann Hospital Houston, Texas Sonia Labarinas, MD - (sonia.labarinas@uth.tmc.edu)
Children's Mercy Kansas City, Missouri Asdis Wagner, MD - (dfwagner@cmh.edu)
Children's Minnesota Hospital Minneapolis, Minnesota Mark Eikenberry, MD - (Mark.Eikenberry@childrensmn.org)
Children's Nebraska Omaha, Nebraska Santosh Kaipa, MD - (skaipa@childrensnebraska.org)
Children's Of Alabama Birmingham, Alabama Robert Richter, MD - (rrichter@peds.aub.edu)
Children's Wisconsin Milwaukee, Wisconsin Adam Szadkowski, MD - (aszadkowski@mcw.edu)
Cincinnati Children's Hospital Medical Center Cincinnati, Ohio Ranjit Chima, MD - (Ranjit.Chima@cchmc.org)
Cleveland Clinic Children's Hospital Cleveland, Ohio Karen Lidsky, MD - (lidskyk@ccf.org)
Cohen Children's Medical Center Queens, New York Todd Sweberg, MD - (tsweberg@northwell.edu)
Comer Children's Hospital Chicago, Illinois Karen Fauman, MD - (krfauman@pds.bsd.uchigago.edu)
Connecticut Children's Medical Center Hartford, Connecticut Allison Cowl, MD - (acowl@connecticutchildrens.org)
Dell Children's Medical Center Austin, Texas Samantha Dallefeld, MD - (samantha.dallefeld@ascension.org)
Duke Children's Hospital & Health Center Durham, North Carolina Palen Mallory, MD - (palen.powelson@duke.edu)
ECMO Centrum Karolinska Stockholm, Lars Broman - (lars.broman@sll.se)
Evelina London Children's Hospital London, Jonathan Lillie - (jonathan.lillie@gstt.nhs.uk)
Freeman Hospital Newcastle upon Tyne, Judit Llevadias - (judit.llevadias@nhs.uk)
Fundación Cardiovascular de Colombia Floridablanca, Leonardo Salazar - (demotucordis@gmail.com)
Great Ormond Street Hospital For Children London, Timothy Thiruchelvam - (timothy.thiruchelvam@gosh.nhs.uk)
Hasbro Children's Providence, Rhode Island Ranna Rozenfeld, MD - (ranna_rozenfeld@brown.edu)
Hassenfeld Children's Hospital at NYU Langone New York, New York Arun Chopra, MD - (arun.chopra@nyulangone.org)
Helen DeVos Children's Hospital Grand Rapids, Michigan Elizabeth Rosner, MD - (Elizabeth.Rosner@helendevoschildrens.org)
Hospital Gregorio Maranon Madrid, Laura Butragueno Laiseca - (laura.butragueno@salud.madrid.org)
Hospital de Santa Maria Lisbon, Francisco Abecasis - (francisco@abecasis.name)
Inova L.J. Murphy Children's Hospital Falls Church, Virginia Jeremy Lamkin, MD - (Jeremy.Lamkin@inova.org)
Istituto Giannina Gaslini Genova, Genoa Andrea Moscatelli - (andreamoscatelli@me.com)
John R. Oishei Children's Hospital Buffalo, New York Ryan Breuer, MD - (rbreuer@upa.chob.edu)
Johns Hopkins Children's Center Baltimore, Maryland Mela Bembea, MD - (mbembea1@jhmi.edu)
Kapi'olani Medical Center for Women & Children Honolulu, Hawaii Len Tanaka, MD - (lent@hawaii.edu)
Le Bonheur Children's Hospital Memphis, Tennessee Hitesh Sandhu, MD - (hsandhu@uthsc.edu)
Leicester Children's Hospital Leicester, Claire Westrope - (claire.westrope@uhl-tr.nhs.uk)
Loma Linda University Children's Hospital Loma Linda, California Merrick Lopez, MD - (MLopez@llu.edu)
Lucile Packard Children's Hospital Stanford Palo Alto, California Timothy Cornell, MD - (tcornell@stanford.edu)
M Health Fairview Masonic Children's Hospital Minneapolis, Minnesota
MUSC Shawn Jenkins Children's Hospital Charleston, South Carolina Elise Zivick, MD - (emrath@musc.edu)
Mayo Eugenio Litta Children's Hospital Rochester, Minnesota Jeffrey Weatherhead, MD - (Weatherhead.Jeffrey@mayo.edu)
Medical City Children's Hospital Dallas, Texas JJ Fanning, MD - (jfanning@pacant.com)
Monroe Carell Jr. Children's Hospital at Vanderbilt Nashville, Tennessee Kevin Johnson, MD - (k.johnson@vumc.org)
N.C. Children's Hospital Chapel Hill, North Carolina Katherine Clement, MD - (katherine_clement@med.unc.edu)
Nationwide Children's Hospital Columbus, Ohio Joshua Frazier, MD - (joshua.frazier@nationwidechildrens.org)
Nemours Children's Hospital, Delaware Wilmington, Delaware Marisa Meyer, MD - (Marisa.Meyer@nemours.org)
Nemours Children's Hospital, Florida Orlando, Florida Timothy Maul, MD - (timothy.maul@nemours.org)
NewYork-Presbyterian Komansky Children's Hospital New York, New York Umesh Joashi, MD - (ucj4001@med.cornell.edu)
NewYork-Presbyterian Morgan Stanley Children's Hospital New York, New York Eva Cheung, MD - (ec2335@cumc.columbia.edu)
Nicklaus Children's Hospital Miami, Florida
Norton Children's Hospital Louisville, Kentucky Deanna Tzanetos, MD - (deanna.tzanetos@louisville.edu)
OHSU Doernbecher Children's Hospital Portland, Oregon Amit Mehta, MD - (mehtaa@ohsu.edu)
OSF Healthcare Children's Hospital of Illinois Peoria, Illinois Agnieszka Kulikowska, MD - (akmd@uic.edu)
Ochsner LSU Health Shreveport Shreveport, Louisiana Steve Conrad, MD - (SConrad@lsuhsc.edu)
Oklahoma Children's Hospital OU Health Oklahoma City, Oklahoma Christine Allen, MD - (Christine-Allen@ouhsc.edu)
Orlando Health Arnold Palmer Hospital for Children Orlando, Florida Nicole Slone, MD - (Nicole.Slone@orlandohealth.com)
Penn State Health Children's Hospital Hershey, Pennsylvania Elizabeth Kerris, MD - (ekerris@pennstatehealth.psu.edu)
Perth Children's Hospital Perth, Western Australia Simon Erickson - (simon.erickson@health.wa.gov.au)
Phoenix Children's Hospital Phoenix, Arizona Erin Kreml, MD - (ekreml@phoenixchildrens.com)
Pontificia Universidad Santiago, Javier Kattan, MD - (kattan@med.puc.cl)
Primary Children's Hospital Salt Lake City, Utah Anna Hubbard, MD - (anna.hubbard@hsc.utah.edu)
Queensland Children's Hospital South Brisbane, Queensland Adrian Mattke - (adrian.mattke@health.qld.gov.au)
Riley Hospital for Children Indianapolis, Indiana Matt Friedman, MD - (friedmml@iu.edu)
Royal Brompton Hospital London, Justin Wang - (Q.Wang@rbht.nhs.uk)
Royal Hospital for Children Glasgow, Mark Davidson - (mark.davidson3@ggc.scot.nhs.uk)
Sanford Children's Hospital Sious Falls, South Dakota Jody Huber, MD - (jody.huber@sanfordhealth.org)
Sant Joan de Deu Barcelona Hospital Barcelona, Susana Segura Matute - (ssegura@sjdhospitalbarcelona.org)
Seattle Children's Hospital Seattle, Washington Thomas Brogan, MD - (thomas.brogan@seattlechildrens.org)
Southampton Children's Hospital Southampton,
St. Louis Children's Hospital St Louis, Missouri Ahmed Said, MD - (said_a@wustl.edu)
Starship Children's Hospital Grafton, Auckland John Beca - (johnbeca@adhb.govt.nz)
Stollery Children's Hospital Edmonton, Alberta Laurance Lequier - (Laurance.Lequier@albertahealthservices.ca)
Texas Children's Hospital Houston, Texas Andrea Ontaneda, MD - (amontan1@texaschildrens.org)
The Children's Hospital at Westmead Westmead, New South Wales Nithesh Singhal - (nitesh.singhal@health.nsw.gov.au)
The Hospital for Sick Children Toronto, Ontario Anne Marie Guerguerian - (anne-marie.guerguerian@sickkids.ca)
The Royal Children's Hospital Melbourne Parkville, Warwick Butt - (warwick.butt@rch.org.au)
UCLA Mattel Children's Hospital Los Angeles, California Neeraj Srivastava, MD - (neerajsrivastava@mednet.ucla.edu)
UCSF Benioff Children's Hospital - San Francisco San Francisco, California Shan Ward, MD - (shan.ward@ucsf.edu)
UCSF Benioff Children's Hospital Oakland Oakland, California Mandeep Chadha, MD - (Mandeep.Chadha@ucsf.edu)
UF Health Shands Children's Hospital Gainesville, Florida Kourtney Guthrie, MD - (ksnodgrass@ufl.edu)
UNM Children's Hospital Albuquerque, New Mexico Senan Hadid, MD - (shadid@salud.umn.edu)
UPMC Children's Hospital of Pittsburgh Pittsburgh, Pennsylvania Nahmah Kim-Campbell, MD - (nahmah.kim-campbell@chp.edu)
UVA Children's Hospital Charlottesville, Virginia Gary Fang, MD - (GYF2N@hscmail.mcc.virginia.edu)
UW Health American Family Children's Hospital Madison, Wisconsin Charlie Bergstrom, MD - (cpbergstrom@wisc.edu)
University Health Women's & Children's Hospital San Antonio, Texas Veronica Armijo-Garcia, MD - (mirelesv@uthscsa.edu)
University of Iowa Health Care Stead Family Children's Hospital Iowa City, Iowa Kari Wellnitz, MD - (kari-wellnitz@uiowa.edu)
University of Maryland Children's Hospital Baltimore, Maryland
University of Michigan - Mott Children's Hospital Ann Arbor, Michigan Kelli McDonough, MS - (kellimcd@umich.edu)
Valley Children's Hospital Madera, California Harry Kallas, MD - (HKallas@valleychildrens.org)
Yale New Haven Children's Hospital New Haven, Connecticut Josep Panisello, MD - (josep.panisello@yale.edu)

Long-Term Development of Muscular Dystrophy Outcome Assessments (GRASP-01-005)

Jennifer Raymond - Jennifer.Raymond@vcuhealth.org

NCT05989620
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Inclusion Criteria:

• Age between 6-50 years at enrollment
• Clinically affected (defined as weakness on bedside evaluation in a pattern consistent with proximal weakness)
• Genetic confirmation of a LGMD, DM2, or LOPD
• FVC above 30% of predicted
Exclusion Criteria:

• Any other illness that would interfere with the ability to undergo safe testing or would interfere with interpretation of the results in the opinion of the site investigator
• Participation in a clinical trial receiving an investigational product
LGMD1B, LGMD1C, LGMD1D, LGMD1E, LGMD1F, LGMD1G, LGMD1H, LGMD2A, LGMD2B, LGMD2C, LGMD2D, LGMD2E, LGMD2F, LGMD2G, LGMD2I, LGMD2J, LGMD2K, LGMD2L, LGMD2M, LGMD2N, LGMD2O, LGMD2P, LGMD2Q, LGMD2S, LGMD2T, LGMD2U, LGMD2W, LGMD2X, LGMD2Y
Muscular Dystrophy, Myotonic Dystrophy, Limb Girdle Muscular Dystrophy, LGMD, LOPD, Late Onset Pompe Disease
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Virginia Commonwealth University Richmond, Virginia Levi Headrick - (levi.headrick@vcuhealth.org)

Lived Experiences of Black Girls in Richmond

Yali Pang, PhD - pangy@vcu.edu

NCT05858281
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Inclusion Criteria (Online Survey and focus groups): * Self-identify as Black/African American adolescent cisgender girls, between the ages of 12-17, and reside in the City of Richmond. Exclusion Criteria (Online Survey and focus groups): * Girls who are not between 12 to 17 years of age, do not self-identify as Black, does not identify as cisgender, legal residence is not located in the city of Richmond, and/or who do not read English. Inclusion Criteria (Interviews): * Parents/guardians (any sex; no age range for parent/guardian) of Black girls (ages 12-17) who reside in the City of Richmond; and * Black emerging adult women (ages 18-22) who resided in the City of Richmond when they were under 18. Exclusion Criteria (Interviews): * Parent/Guardian - Does not have a child (daughter) between the ages of 12-17; child does not self-identify as cisgender and Black/African American; legal residence is not in the city of Richmond; unable to read, write, or speak in English. * Emerging adult women - does not self-identify as Black/African American, under 18 or over the age of 22, did not reside in the City of Richmond under 18, and unable to read, write, or speak in English.
BEHAVIORAL: Survey, BEHAVIORAL: Interviews, BEHAVIORAL: Focus group
Lived Experiences, Strengths, and Community Assets of Black Girls
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Virginia Commonwealth University Richmond, Virginia

Brain Oxygen Optimization in Severe TBI, Phase 3 (BOOST3)

William Barsan, MD - wbarsan@umich.edu

NCT03754114
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Inclusion Criteria:
* Non-penetrating traumatic brain injury * Glasgow Coma Scale (GCS) 3-8 measured off paralytics * Glasgow Coma Scale motor score \< 6 if endotracheally intubated * Evidence of intracranial trauma on CT scan * Able to place intracranial probes and randomize within 6 hours of arrival at enrolling hospital * Able to place intracranial probes and randomize within 12 hours from injury * Age greater than or equal to 14 years
Exclusion Criteria:
* Non-survivable injury * Bilaterally absent pupillary response in the absence of paralytic medication * Contraindication to the placement of intracranial probes * Treatment of brain tissue oxygen values prior to randomization * Planned use of devices which may unblind treating physicians to brain tissue hypoxia * Systemic sepsis at screening * Refractory hypotension * Refractory systemic hypoxia * PaO2/FiO2 ratio \< 150 * Known pre-existing neurologic disease with confounding residual neurological deficits * Known inability to perform activities of daily living (ADL) without assistance prior to injury * Known active drug or alcohol dependence that, in the opinion of site investigator, would interfere with physiological response to brain tissue oxygen treatments * Pregnancy * Prisoner * On EFIC Opt-Out list as indicated by a bracelet or medical alert
OTHER: ICP + PbtO2 guided management strategy, OTHER: ICP guided management strategy
Brain Injuries, Traumatic
intracranial pressure, hypoxia, brain, critical care, emergency treatment, monitoring, physiologic
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Ben Taub General Hospital Houston, Texas
Beth Israel Deaconess Medical Center Boston, Massachusetts
Brigham and Women's Hospital Boston, Massachusetts
CIUSSS-NIM Hopital du Sacre - Coeur de Montreal Montreal,
Cedars-Sinai Medical Center Los Angeles, California
Cooper University Hospital Camden, New Jersey
Detroit Receiving Hospital Detroit, Michigan
Duke University Hospital Durham, North Carolina
Froedtert Hospital Milwaukee, Wisconsin
Grady Memorial Hospital Delaware, Ohio
Harborview Medical Center Seattle, Washington
Henry Ford Hospital Detroit, Michigan
Inova Fairfax Hospital Falls Church, Virginia
Jacobi Medical Center The Bronx, New York
Johns Hopkins Hospital Baltimore, Maryland Ruben Troncoso Jr, MPH, MD - (rubent@jhmi.edu)
Kings County Hospital Center Brooklyn, New York
Maine Medical Center Portland, Maine
Massachusetts General Hospital Boston, Massachusetts
Medstar Washington Hospital Center Washington D.C., District of Columbia
Memorial Hermann Hospital Houston, Texas
NYP Columbia University Medical Center New York, New York
North Shore University Hospital Manhasset, New York
OSU Wexner Medical Center Columbus, Ohio
Oregon Health & Science University Hospital Portland, Oregon James M. Wright III, MD - (wrighjam@ohsu.edu)
Parkland Hospital Dallas, Texas
Penn Presbyterian Medical Center Philadelphia, Pennsylvania
Regions Hospital Saint Paul, Minnesota
Riverside Methodist Hospital Columbus, Ohio
Ronald Reagan UCLA Medical Center Los Angeles, California
SUNY Upstate Medical University Syracuse, New York Devin J. Burke, MD - (BURKEDE@upstate.edu)
San Francisco General Hospital San Francisco, California
St. Michaels Hospital Toronto, Ontario
St. Vincent Hospital Indianapolis, Indiana
Stanford University Medical Center Stanford, California
Strong Memorial Hospital Rochester, New York David A. Paul, MD MS - (David_Paul@URMC.Rochester.edu)
The Queen's Medical Center Honolulu, Hawaii
Thomas Jefferson University Hospital Philadelphia, Pennsylvania
UC Davis Medical Center Sacramento, California
UF Health Shands Hospital Gainesville, Florida
UMass Memorial Medical Center Worcester, Massachusetts
UPMC Presbyterian Hospital Pittsburgh, Pennsylvania
University of Calgary - Foothills Medical Centre Calgary, Alberta Andreas H. Kramer, MD MSc FRCPC - (Andreas.Kramer@albertahealthservices.ca)
University of Chicago Medical Center Chicago, Illinois
University of Cincinnati Medical Center Cincinnati, Ohio
University of Colorado Hospital Aurora, Colorado
University of Maryland Medical Center Baltimore, Maryland
University of Michigan Ann Arbor, Michigan
University of New Mexico Hospital Albuquerque, New Mexico
University of North Carolina Medical Center Chapel Hill, North Carolina
University of Texas Health Science Center San Antonio San Antonio, Texas
University of Utah Healthcare Salt Lake City, Utah
VCU Medical Center Richmond, Virginia
WVU Healthcare Ruby Memorial Hospital Morgantown, West Virginia
Yale New Haven Hospital New Haven, Connecticut

Registry of Avance® Nerve Graft's Utilization and Recovery Outcomes Post Peripheral Nerve Reconstruction (RANGER®)

Stacy Arnold - clinicalresearch@axogeninc.com

NCT01526681
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Primary Study Criteria (RANGER Avance):
Inclusion Criteria:
* Males and Females who have undergone nerve repair using the Avance® Nerve Graft for the repair of a nerve injury * Returned for at least one post-operative follow-up visit
Exclusion Criteria:
• Subject who in the opinion of the investigator, have not or likely will not complete at least some portion of the investigator's recommended follow-up. Addendum 1 (MATCH) Criteria:
Inclusion Criteria:
* Have nerve transection injuries to the upper extremity; * Have undergone tension free end to end nerve coaptation on both the proximal and distal portion of the nerve gap with nerve autograft or nerve entubulation with nerve tube conduit at a participating ANG-CP-005 registry site after 2004 and; * Have completed sufficient follow-up assessments at a regeneration rate of 2mm/day to determine the outcomes of the repair or is willing to comply with site specific post-operative care procedures and assessments to determine the outcome of the repair.
Exclusion Criteria:
* Direct nerve repairs; * Nerve gaps greater than 70mm; * Subjects who, in the opinion of the investigator, were non-compliant to the investigator's post-operative treatment or rehabilitation instructions; * Any subject who at the discretion of the Investigator is not suitable for inclusion in the study. Addendum 2 (Sensation-NOW) Criteria:
Inclusion Criteria:
* Female ≥ 18 years old * Undergo post mastectomy autologous breast reconstruction with one type of autologous flap (no stacked reconstructions or use of implant with autologous flap) * Neurotization must be completed using a donor nerve from the flap and a recipient nerve from the chest * Complete Sensory Assessment Testing with Semmes Weinstein Monofilaments (SWMF) and the following Breast-Q Questionnaires 60 - 120 days post-reconstruction: * Breast-Q Physical Well Being of the Chest * Breast-Q Satisfaction with Breast * Breast-Q Physical Well Being of the Abdomen * Breast-Q Abnormal Breast Sensations * Breast-Q Impact of Breast Sensation on Quality of Life * Breast-Q Return of Breast Sensation * Able to provide informed consent and are willing to comply with post-operative care procedures and assessments
Exclusion Criteria:
* Surgical history of secondary revision surgery for partial or total flap loss * Bilateral reconstruction with non-uniform treatment (i.e. 1 reconstructed breast is non-neurotized, 1 reconstructed breast is neurotized) * Currently prescribed medication known to impact nerve regeneration or to cause peripheral neuropathy * Currently undergoing IV chemotherapy or radiation * Any subject who at the discretion of the Investigator is not suitable for inclusion in the study or is unlikely to comply with follow-up schedule Additional Eligibility criteria to Modules Module 1: Native Skin Reconstructions with and without neurotization. * Buried flap reconstructions from nipple sparing mastectomy or skin sparing mastectomy OR a breast reconstruction from a skin sparing mastectomy with exposed flap skin in the peri-areolar region. * Sensory assessments must be completed on ≥ 8 Zones of Native Skin. * Center zone measurement may be on either Native Skin or Flap Skin. * All Inner and Outer zone measurements must be on Native Skin. * De-identified photo of the breast reconstruction with 9 zones identified.
OTHER: Processed Human Nerve Graft, OTHER: Standard Treatment, Autogenous Nerve Graft, Direct Suture, etc., OTHER: Autogenous Nerve Graft, DEVICE: Nerve Tube Conduit, PROCEDURE: Autologous Breast Reconstruction with Neurotization, PROCEDURE: Autologous Breast Reconstruction without Neurotization
Peripheral Nerve Injuries
Sensory Nerve, Mixed Nerve, Motor Nerve, Neurotization, Nerve Injury, Peripheral Nerve Injury
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MATCH: Hennepin County Medical Center Minneapolis, Minnesota
RANGER & MATCH: Arizona Center for Hand Surgery Phoenix, Arizona
RANGER & MATCH: Campbell Clinic Germantown, Tennessee
RANGER & MATCH: Florida Orthopaedic Institute Tampa, Florida
RANGER & MATCH: OrthoCarolina Research Institute, Inc. Charlotte, North Carolina
RANGER & MATCH: The Buncke Clinic San Francisco, California
RANGER & MATCH: University Hospital Birmingham, England Edgbaston, Birmingham
RANGER & MATCH: University of California - Irvine Orange, California
RANGER & MATCH: University of Kansas Medical Center Kansas City, Kansas
RANGER & MATCH: University of Missouri - Columbia Columbia, Missouri
RANGER & MATCH: University of Washington Seattle, Washington
RANGER & MATCH: Vanderbilt University Nashville, Tennessee
RANGER: Cleveland Clinic Cleveland, Ohio
RANGER: Duke University Durham, North Carolina
RANGER: Hand & Upper Extremity Center of Georgia/Children's Hospital of Atlanta Atlanta, Georgia
RANGER: Johns Hopkins University Baltimore, Maryland
RANGER: Multi-Disciplinary Specialists Rutherford, New Jersey
RANGER: North York General Hospital Toronto, Ontario
RANGER: Ohio State University Medical Center Columbus, Ohio
RANGER: Phoenix Children's Hospital Phoenix, Arizona
RANGER: San Antonio Military Medical Center San Antonio, Texas
RANGER: Texas Tech University HSC Lubbock, Texas
RANGER: University Hospital Vienna,
RANGER: University of Cincinnati Cincinnati, Ohio
RANGER: University of Kentucky Lexington, Kentucky
RANGER: University of Miami Miami, Florida
RANGER: University of North Texas/John Peter Smith Hospital Fort Worth, Texas
RANGER: Walter Reed National Military Medical Center Bethesda, Maryland
Sensation-NOW: Advanced Reconstructive Care, LLC Metairie, Louisiana
Sensation-NOW: Baylor College of Medicine Houston, Texas
Sensation-NOW: East Cooper Plastic Surgery Mount Pleasant, South Carolina
Sensation-NOW: George Washington University Washington, District of Columbia
Sensation-NOW: Houston-Methodist Central Houston, Texas
Sensation-NOW: Houston-Methodist West/North Houston, Texas
Sensation-NOW: Johns Hopkins University Baltimore, Maryland
Sensation-NOW: Joshua Lemmon, MD, PLLC Richardson, Texas
Sensation-NOW: Ohio State University Medical Center Columbus, Ohio
Sensation-NOW: PRMA Plastic Surgery San Antonio, Texas
Sensation-NOW: Stanford University Stanford, California
Sensation-NOW: University of Cincinnati Cincinnati, Ohio
Sensation-NOW: University of Colorado School of Medicine Aurora, Colorado
Sensation-NOW: University of Kansas Medical Center Kansas City, Kansas
Sensation-NOW: University of Nebraska Medical Center Omaha, Nebraska
Sensation-NOW: University of Nevada, Las Vegas Las Vegas, Nevada
Sensation-NOW: University of North Texas/John Peter Smith Hospital Fort Worth, Texas
Sensation-NOW: University of Pennsylvania Philadelphia, Pennsylvania
Sensation-NOW: University of Texas Southwestern Medical Center Dallas, Texas
Sensation-NOW: Vanderbilt University Nashville, Tennessee
Sensation-NOW: Virginia Commonwealth University Richmond, Virginia