New study aims to uncover hidden health risks in down syndrome leukemia survivors
NCT ID NCT05702645
First seen Jun 27, 2026 · Last updated Aug 26, 2026 · Updated 2 times
Summary
This study looks at the long-term health of people with Down syndrome who have been treated for acute leukemia. Researchers want to understand what chronic health problems survivors may face and what factors contribute to them. The goal is to create better follow-up care guidelines to improve quality of life. The study will enroll 330 survivors aged 6 to 39.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 330 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Jun 2029
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
DS-AL survivors from the Children's Oncology Group (COG) Registry and Epidemiology protocols or locally from participating institutions.
- Ages
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6 to 39 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients age \>= 6 and \< 40 years at the time of enrollment * A diagnosis of Down syndrome is required, and may include any of the three recognized types: trisomy 21 resulting from chromosomal nondisjunction (most common), translocation (the patient has 46 chromosomes, but all or part of an additional copy of chromosome 21 is attached to another chromosome), or mosaicism (trisomy 21 that is present in only a fraction of cells) * All patients must be DS-AL survivors (acute lymphoblastic leukemia \[ALL\] or acute myeloid leukemia \[AML\]) * Note 1: Myeloid leukemia of Down syndrome (ML-DS) is included in the AML category above. Per the World Health Organization (WHO) definition of ML-DS, this diagnosis encompasses both myelodysplastic syndrome (MDS) and overt AML. Also, note that survivors of relapsed disease are eligible, so long as the patient otherwise meets eligibility criteria, i.e., treatment for relapse was completed at least 36 calendar months prior to enrollment and did not include stem cell transplant * Note 2: A diagnosis of transient abnormal myelopoiesis (TAM), also known as transient myeloproliferative disease (TMD), is not alone sufficient for inclusion in this study * Patients must have been treated for ALL or AML * Note: History of COG therapeutic trial participation is not required. As a reminder ML-DS would be included under the AML category here above * All cancer treatment (oral or intravenous) must have been completed at least 36 calendar months prior to enrollment * Patients must have a life expectancy of \> 1 year * Patient and parent of subject must be either English or Spanish speaking. At least one parent or guardian must be able to read and write in English or Spanish * Note: Parents or guardians are responsible for completing all questionnaires, even in the case of subjects that are \>= 18 years old * 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 history of hematopoietic stem cell transplant (HSCT) are excluded * Note: Patients with previous chimeric antigen receptor T-cell (CAR T-cell) therapy, and other cellular cancer therapies can participate, as long as all other eligibility criteria are satisfied * Patients with a history of cancers prior to their ALL or AML diagnosis are excluded. Patients that developed a subsequent malignant neoplasm following their ALL or AML diagnosis are also excluded * Note: Prior history of transient abnormal myelopoiesis is allowed, but is not sufficient for eligibility * Patients whose parents or guardians are unable to complete the required forms are excluded
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
73 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Locations
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Albany Medical Center
RECRUITINGAlbany, New York, 12208, United States
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Alfred I duPont Hospital for Children
RECRUITINGWilmington, Delaware, 19803, United States
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Alliance for Childhood Diseases/Cure 4 the Kids Foundation
RECRUITINGLas Vegas, Nevada, 89135, United States
Contact Email: •••••@•••••
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Augusta University Medical Center
RECRUITINGAugusta, Georgia, 30912, United States
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BI-LO Charities Children's Cancer Center
RECRUITINGGreenville, South Carolina, 29605, United States
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Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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Bronson Methodist Hospital
RECRUITINGKalamazoo, Michigan, 49007, United States
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C S Mott Children's Hospital
RECRUITINGAnn Arbor, Michigan, 48109, United States
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Children's Healthcare of Atlanta - Arthur M Blank Hospital
RECRUITINGAtlanta, Georgia, 30329, United States
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Children's Hospital
RECRUITINGLondon, Ontario, N6A 5W9, Canada
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Children's Hospital Medical Center of Akron
RECRUITINGAkron, Ohio, 44308, United States
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Children's Hospital and Medical Center of Omaha
RECRUITINGOmaha, Nebraska, 68114, United States
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Children's Hospital of Alabama
RECRUITINGBirmingham, Alabama, 35233, United States
Contact Email: •••••@•••••
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Children's Hospital of Michigan
RECRUITINGDetroit, Michigan, 48201, United States
Contact Email: •••••@•••••
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Children's Hospital of Philadelphia
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
Contact Email: •••••@•••••
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Children's Hospital of Pittsburgh of UPMC
RECRUITINGPittsburgh, Pennsylvania, 15224, United States
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Children's Hospital of Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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Children's Hospitals and Clinics of Minnesota - Minneapolis
RECRUITINGMinneapolis, Minnesota, 55404, United States
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Children's Mercy Hospitals and Clinics
RECRUITINGKansas City, Missouri, 64108, United States
Contact Email: •••••@•••••
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Cleveland Clinic Foundation
RECRUITINGCleveland, Ohio, 44195, United States
Contact Email: •••••@•••••
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Cook Children's Medical Center
RECRUITINGFort Worth, Texas, 76104, United States
Contact Email: •••••@•••••
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Corewell Health Grand Rapids Hospitals - Helen DeVos Children's Hospital
RECRUITINGGrand Rapids, Michigan, 49503, United States
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Dayton Children's Hospital
RECRUITINGDayton, Ohio, 45404, United States
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Dell Children's Medical Center of Central Texas
RECRUITINGAustin, Texas, 78723, United States
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East Tennessee Childrens Hospital
RECRUITINGKnoxville, Tennessee, 37916, United States
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Golisano Children's Hospital of Southwest Florida
RECRUITINGFort Myers, Florida, 33908, United States
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Hackensack University Medical Center
RECRUITINGHackensack, New Jersey, 07601, United States
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Kaiser Permanente-Oakland
RECRUITINGOakland, California, 94611, United States
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Kapiolani Medical Center for Women and Children
RECRUITINGHonolulu, Hawaii, 96826, United States
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Lurie Children's Hospital-Chicago
RECRUITINGChicago, Illinois, 60611, United States
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Marshfield Medical Center-Marshfield
RECRUITINGMarshfield, Wisconsin, 54449, United States
Contact Email: •••••@•••••
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Memorial Regional Hospital/Joe DiMaggio Children's Hospital
RECRUITINGHollywood, Florida, 33021, United States
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Montefiore Medical Center - Moses Campus
RECRUITINGThe Bronx, New York, 10467, United States
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Nationwide Children's Hospital
RECRUITINGColumbus, Ohio, 43205, United States
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Nemours Children's Clinic - Pensacola
RECRUITINGPensacola, Florida, 32504, United States
Contact Email: •••••@•••••
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Nemours Children's Clinic-Jacksonville
RECRUITINGJacksonville, Florida, 32207, United States
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Nemours Children's Hospital
RECRUITINGOrlando, Florida, 32827, United States
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Oregon Health and Science University
RECRUITINGPortland, Oregon, 97239, United States
Contact Email: •••••@•••••
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Phoenix Childrens Hospital
RECRUITINGPhoenix, Arizona, 85016, United States
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Prisma Health Richland Hospital
RECRUITINGColumbia, South Carolina, 29203, United States
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Providence Sacred Heart Medical Center and Children's Hospital
RECRUITINGSpokane, Washington, 99204, United States
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Rady Children's Hospital - San Diego
RECRUITINGSan Diego, California, 92123, United States
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Rainbow Babies and Childrens Hospital
RECRUITINGCleveland, Ohio, 44106, United States
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Renown Regional Medical Center
RECRUITINGReno, Nevada, 89502, United States
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Rhode Island Hospital
RECRUITINGProvidence, Rhode Island, 02903, United States
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Roswell Park Cancer Institute
RECRUITINGBuffalo, New York, 14263, United States
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Saint Joseph's Hospital/Children's Hospital-Tampa
RECRUITINGTampa, Florida, 33607, United States
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Saint Jude Children's Research Hospital
RECRUITINGMemphis, Tennessee, 38105, United States
Contact Email: •••••@•••••
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Sanford Broadway Medical Center
RECRUITINGFargo, North Dakota, 58122, United States
Contact Email: •••••@•••••
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Sanford USD Medical Center - Sioux Falls
RECRUITINGSioux Falls, South Dakota, 57117-5134, United States
Contact Email: •••••@•••••
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Seattle Children's Hospital
RECRUITINGSeattle, Washington, 98105, United States
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Sinai Hospital of Baltimore
RECRUITINGBaltimore, Maryland, 21215, United States
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Summerlin Hospital Medical Center
RECRUITINGLas Vegas, Nevada, 89144, United States
Contact Email: •••••@•••••
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Sunrise Hospital and Medical Center
RECRUITINGLas Vegas, Nevada, 89109, United States
Contact Email: •••••@•••••
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UCSF Benioff Children's Hospital Oakland
RECRUITINGOakland, California, 94609, United States
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UCSF Medical Center-Mission Bay
RECRUITINGSan Francisco, California, 94158, United States
Contact Email: •••••@•••••
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UNC Lineberger Comprehensive Cancer Center
RECRUITINGChapel Hill, North Carolina, 27599, United States
Contact Email: •••••@•••••
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UT MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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UT Southwestern/Simmons Cancer Center-Dallas
RECRUITINGDallas, Texas, 75390, United States
Contact Email: •••••@•••••
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University Medical Center of Southern Nevada
RECRUITINGLas Vegas, Nevada, 89102, United States
Contact Email: •••••@•••••
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University of California Davis Comprehensive Cancer Center
RECRUITINGSacramento, California, 95817, United States
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University of Chicago Comprehensive Cancer Center
RECRUITINGChicago, Illinois, 60637, United States
Contact Email: •••••@•••••
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University of Minnesota/Masonic Cancer Center
RECRUITINGMinneapolis, Minnesota, 55455, United States
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University of Mississippi Medical Center
RECRUITINGJackson, Mississippi, 39216, United States
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University of Nebraska Medical Center
RECRUITINGOmaha, Nebraska, 68198, United States
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University of Oklahoma Health Sciences Center
RECRUITINGOklahoma City, Oklahoma, 73104, United States
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University of Texas Health Science Center at San Antonio
RECRUITINGSan Antonio, Texas, 78229, United States
Contact Email: •••••@•••••
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University of Wisconsin Carbone Cancer Center - University Hospital
RECRUITINGMadison, Wisconsin, 53792, United States
Contact Email: •••••@•••••
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Valley Children's Hospital
RECRUITINGMadera, California, 93636, United States
Contact Email: •••••@•••••
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Vanderbilt University/Ingram Cancer Center
RECRUITINGNashville, Tennessee, 37232, United States
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Wake Forest University Health Sciences
RECRUITINGWinston-Salem, North Carolina, 27157, United States
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Washington University School of Medicine
RECRUITINGSt Louis, Missouri, 63110, United States
Contact Email: •••••@•••••
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Yale University
RECRUITINGNew Haven, Connecticut, 06520, United States
Contact Email: •••••@•••••
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