A Study to Learn More About the Health of Persons With Down Syndrome After Treatment for Acute Leukemia
Start Date
11/30/2023
Completion Date
6/30/2029
Summary
This study attempts to learn more about the health of persons with Down syndrome after treatment for acute leukemia. Children with Down syndrome are at increased risk for side effects during treatment for acute leukemia, but it is unclear of their risk for long-term effects of cancer treatment. By learning more about the factors that may contribute to chronic health conditions and long-term effects after treatment for leukemia in persons with Down syndrome, clinical practice guidelines for survivorship care can be developed to help improve their quality-of-life.
Detailed Description
PRIMARY OBJECTIVE: I. To determine the prevalence, type, and severity of chronic health conditions (CHC) in survivors of Down syndrome-associated acute leukemia (DS-AL), and to compare CHC with frequency-matched DS individuals that have no cancer history. SECONDARY OBJECTIVES: I. To characterize post-treatment clinical outcomes of DS-AL by prospective, in-person assessment. II. To determine the prevalence and severity of parent-reported adverse neuropsychological (NP) outcomes in survivors of DS-AL, compared with frequency-matched DS individuals with no cancer history. III. To determine health-related quality of life (HRQOL) in survivors of DS-AL, compared with frequency-matched DS individuals with no cancer history. IV. To identify clinical risk determinants of CHC, NP, and clinical outcomes in survivors of DS-AL. V. To establish a well-annotated cohort of survivors of DS-AL and associated biobank as a resource for future investigations. EXPLORATORY OBJECTIVES: I. For DS-acute lymphoblastic leukemia (DS-ALL), test if structural birth defects and genetic associations with etiology extend to CHC. II. For DS-ALL, test if telomere length determined by polygenic risk score and telomere flow-fluorescence in situ hybridization (FISH) are associated with outcomes from in-person NP assessment. OUTLINE: Patients undergo an optional saliva/buccal swab in part 1 and clinical assessment in part 2 of the study. Patients with DS-ALL may then undergo blood sample collection and neurocognitive assessment in part 3 of the study.
Eligibility Criteria
Age Range: 6 years to 39 years
Interventions
Biospecimen Collection
Clinical Evaluation
Neurocognitive Assessment
Questionnaire Administration
Survey Administration
Conditions
Locations
Children's Hospital of Alabama
Birmingham, Alabama 35233
United States
Phoenix Childrens Hospital
Phoenix, Arizona 85016
United States
Valley Children's Hospital
Madera, California 93636
United States
UCSF Benioff Children's Hospital Oakland
Oakland, California 94609
United States
Kaiser Permanente-Oakland
Oakland, California 94611
United States
University of California Davis Comprehensive Cancer Center
Sacramento, California 95817
United States
Rady Children's Hospital - San Diego
San Diego, California 92123
United States
UCSF Medical Center-Mission Bay
San Francisco, California 94158
United States
Yale University
New Haven, Connecticut 06520
United States
Alfred I duPont Hospital for Children
Wilmington, Delaware 19803
United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida 33908
United States
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida 33021
United States
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida 32207
United States
Nemours Children's Hospital
Orlando, Florida 32827
United States
Nemours Children's Clinic - Pensacola
Pensacola, Florida 32504
United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida 33607
United States
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia 30329
United States
Augusta University Medical Center
Augusta, Georgia 30912
United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii 96826
United States
Lurie Children's Hospital-Chicago
Chicago, Illinois 60611
United States
Sinai Hospital of Baltimore
Baltimore, Maryland 21215
United States
C S Mott Children's Hospital
Ann Arbor, Michigan 48109
United States
Children's Hospital of Michigan
Detroit, Michigan 48201
United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota 55404
United States
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesota 55455
United States
University of Mississippi Medical Center
Jackson, Mississippi 39216
United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri 64108
United States
Washington University School of Medicine
St Louis, Missouri 63110
United States
Children's Hospital and Medical Center of Omaha
Omaha, Nebraska 68114
United States
University of Nebraska Medical Center
Omaha, Nebraska 68198
United States
University Medical Center of Southern Nevada
Las Vegas, Nevada 89102
United States
Sunrise Hospital and Medical Center
Las Vegas, Nevada 89109
United States
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada 89135
United States
Summerlin Hospital Medical Center
Las Vegas, Nevada 89144
United States
Renown Regional Medical Center
Reno, Nevada 89502
United States
Hackensack University Medical Center
Hackensack, New Jersey 07601
United States
Albany Medical Center
Albany, New York 12208
United States
Roswell Park Cancer Institute
Buffalo, New York 14263
United States
Montefiore Medical Center - Moses Campus
The Bronx, New York 10467
United States
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina 27599
United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina 27157
United States
Sanford Broadway Medical Center
Fargo, North Dakota 58122
United States
Children's Hospital Medical Center of Akron
Akron, Ohio 44308
United States
Rainbow Babies and Childrens Hospital
Cleveland, Ohio 44106
United States
Cleveland Clinic Foundation
Cleveland, Ohio 44195
United States
Nationwide Children's Hospital
Columbus, Ohio 43205
United States
Dayton Children's Hospital
Dayton, Ohio 45404
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United States
Oregon Health and Science University
Portland, Oregon 97239
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania 15224
United States
Rhode Island Hospital
Providence, Rhode Island 02903
United States
Prisma Health Richland Hospital
Columbia, South Carolina 29203
United States
BI-LO Charities Children's Cancer Center
Greenville, South Carolina 29605
United States
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
United States
East Tennessee Childrens Hospital
Knoxville, Tennessee 37916
United States
Saint Jude Children's Research Hospital
Memphis, Tennessee 38105
United States
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
United States
Dell Children's Medical Center of Central Texas
Austin, Texas 78723
United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas 75390
United States
Cook Children's Medical Center
Fort Worth, Texas 76104
United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas 77030
United States
M D Anderson Cancer Center
Houston, Texas 77030
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United States
Seattle Children's Hospital
Seattle, Washington 98105
United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington 99204
United States
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin 53792
United States
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin 53226
United States
Children's Hospital
London, Ontario N6A 5W9
Canada