Actively Recruiting
Chronic Health Conditions in Down Syndrome-Associated Acute Leukemia: The Down Syndrome Phenotyping Acute Leukemia Study in Survivors (DS-PALS Survivors)
Led by Children's Oncology Group · Updated on 2026-05-05
330
Participants Needed
70
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the health of people with Down syndrome who have been treated for acute leukemia. Children with Down syndrome face higher risks of side effects during leukemia treatment, but it's unclear how this affects their long-term health. The study aims to understand chronic health conditions and other lasting effects after leukemia treatment in this group to help improve their quality of life and develop better care guidelines. Participants may provide saliva or buccal swab samples, undergo clinical assessments, and, if they have Down syndrome-associated acute lymphoblastic leukemia, may also give blood samples and complete neurocognitive tests. These evaluations are done in parts, including biospecimen collection, clinical evaluation, and neurocognitive assessment. During the study, participants will be assessed for chronic health conditions, neuropsychological outcomes reported by parents, health-related quality of life, and clinical risk factors. Researchers will also create a detailed group of survivors and a biobank for future research. The main outcome measured is the prevalence, type, and severity of chronic health conditions. The study will continue until June 2029, with ongoing assessments and data collection.
CONDITIONS
Brief Title
A Study to Learn More About the Health of Persons With Down Syndrome After Treatment for Acute Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 6 to less than 40 years at enrollment
- Diagnosis of Down syndrome including trisomy 21 by nondisjunction, translocation, or mosaicism
- Survivors of Down syndrome-associated acute lymphoblastic leukemia or acute myeloid leukemia
- Completed all cancer treatments at least 36 months before enrollment
- Life expectancy greater than 1 year
- Patient and parent/guardian speak and read English or Spanish
- Written informed consent obtained
- Compliance with institutional, FDA, and NCI human study requirements
You will not qualify if you...
- History of hematopoietic stem cell transplant
- History of cancers prior to leukemia diagnosis or subsequent malignant neoplasm after leukemia
- Unable of parent or guardian to complete required forms
- Diagnosis of transient abnormal myelopoiesis alone is not sufficient for inclusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to study completion
Participants undergo a clinical assessment to evaluate health status and post-treatment outcomes.
1 or more visits depending on assessments
Duration - Up to study completion
Participants may provide saliva/buccal swab and blood samples for research purposes.
1 or more visits depending on sample collection
Duration - Up to study completion
Participants with Down syndrome-associated acute lymphoblastic leukemia may undergo neurocognitive testing to assess neuropsychological outcomes.
1 or more visits for neurocognitive testing
Trial Site Locations
Total: 70 locations
1
Children's Hospital of Alabama
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
3
Valley Children's Hospital
Madera, California, United States, 93636
Actively Recruiting
4
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States, 94609
Actively Recruiting
5
Kaiser Permanente-Oakland
Oakland, California, United States, 94611
Actively Recruiting
6
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
7
Rady Children's Hospital - San Diego
San Diego, California, United States, 92123
Actively Recruiting
8
UCSF Medical Center-Mission Bay
San Francisco, California, United States, 94158
Actively Recruiting
9
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
10
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States, 19803
Actively Recruiting
11
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, United States, 33908
Actively Recruiting
12
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, United States, 33021
Actively Recruiting
13
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, United States, 32207
Actively Recruiting
14
Nemours Children's Hospital
Orlando, Florida, United States, 32827
Actively Recruiting
15
Nemours Children's Clinic - Pensacola
Pensacola, Florida, United States, 32504
Actively Recruiting
16
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, United States, 33607
Actively Recruiting
17
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, United States, 30329
Actively Recruiting
18
Augusta University Medical Center
Augusta, Georgia, United States, 30912
Actively Recruiting
19
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, United States, 96826
Actively Recruiting
20
Lurie Children's Hospital-Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
21
Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
Actively Recruiting
22
C S Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
23
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Actively Recruiting
24
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
25
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
26
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
Actively Recruiting
27
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Actively Recruiting
28
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
29
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska, United States, 68114
Actively Recruiting
30
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
31
University Medical Center of Southern Nevada
Las Vegas, Nevada, United States, 89102
Actively Recruiting
32
Sunrise Hospital and Medical Center
Las Vegas, Nevada, United States, 89109
Actively Recruiting
33
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, United States, 89135
Actively Recruiting
34
Summerlin Hospital Medical Center
Las Vegas, Nevada, United States, 89144
Actively Recruiting
35
Renown Regional Medical Center
Reno, Nevada, United States, 89502
Actively Recruiting
36
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
37
Albany Medical Center
Albany, New York, United States, 12208
Actively Recruiting
38
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
39
Montefiore Medical Center - Moses Campus
The Bronx, New York, United States, 10467
Actively Recruiting
40
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
41
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
42
Sanford Broadway Medical Center
Fargo, North Dakota, United States, 58122
Actively Recruiting
43
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308
Actively Recruiting
44
Rainbow Babies and Childrens Hospital
Cleveland, Ohio, United States, 44106
Actively Recruiting
45
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Actively Recruiting
46
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
47
Dayton Children's Hospital
Dayton, Ohio, United States, 45404
Actively Recruiting
48
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
49
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
50
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
51
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
52
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
53
Prisma Health Richland Hospital
Columbia, South Carolina, United States, 29203
Actively Recruiting
54
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, United States, 29605
Actively Recruiting
55
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
Actively Recruiting
56
East Tennessee Childrens Hospital
Knoxville, Tennessee, United States, 37916
Actively Recruiting
57
Saint Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
58
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
59
Dell Children's Medical Center of Central Texas
Austin, Texas, United States, 78723
Actively Recruiting
60
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, United States, 75390
Actively Recruiting
61
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Actively Recruiting
62
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
63
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
64
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
65
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
66
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, United States, 99204
Actively Recruiting
67
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
68
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States, 54449
Actively Recruiting
69
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
70
Children's Hospital
London, Ontario, Canada, N6A 5W9
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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