Chronic Health Conditions in Down Syndrome-Associated Acute Leukemia: The Down Syndrome Phenotyping Acute Leukemia Study in Survivors (DS-PALS Survivors)

Status: Recruiting
Location: See all (52) locations...
Intervention Type: Procedure, Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 39
Healthy Volunteers: f
View:

• 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: Myeloid leukemia of Down syndrome (ML-DS) would be included under AML category above. 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

• 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 forms, 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

Locations
United States
California
Valley Children's Hospital
RECRUITING
Madera
UCSF Benioff Children's Hospital Oakland
RECRUITING
Oakland
UCSF Medical Center-Mission Bay
RECRUITING
San Francisco
Delaware
Alfred I duPont Hospital for Children
RECRUITING
Wilmington
Florida
Golisano Children's Hospital of Southwest Florida
RECRUITING
Fort Myers
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
RECRUITING
Hollywood
Nemours Children's Clinic-Jacksonville
RECRUITING
Jacksonville
Nemours Children's Hospital
RECRUITING
Orlando
Saint Joseph's Hospital/Children's Hospital-Tampa
RECRUITING
Tampa
Georgia
Children's Healthcare of Atlanta - Arthur M Blank Hospital
RECRUITING
Atlanta
Augusta University Medical Center
RECRUITING
Augusta
Maryland
Sinai Hospital of Baltimore
RECRUITING
Baltimore
Michigan
C S Mott Children's Hospital
RECRUITING
Ann Arbor
Missouri
Children's Mercy Hospitals and Clinics
RECRUITING
Kansas City
Washington University School of Medicine
RECRUITING
Saint Louis
Mississippi
University of Mississippi Medical Center
RECRUITING
Jackson
North Carolina
UNC Lineberger Comprehensive Cancer Center
RECRUITING
Chapel Hill
Wake Forest University Health Sciences
RECRUITING
Winston-salem
North Dakota
Sanford Broadway Medical Center
RECRUITING
Fargo
Nebraska
Children's Hospital and Medical Center of Omaha
RECRUITING
Omaha
University of Nebraska Medical Center
RECRUITING
Omaha
New Jersey
Hackensack University Medical Center
RECRUITING
Hackensack
Nevada
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
RECRUITING
Las Vegas
Summerlin Hospital Medical Center
RECRUITING
Las Vegas
Sunrise Hospital and Medical Center
RECRUITING
Las Vegas
University Medical Center of Southern Nevada
RECRUITING
Las Vegas
Renown Regional Medical Center
RECRUITING
Reno
New York
Albany Medical Center
RECRUITING
Albany
Montefiore Medical Center - Moses Campus
RECRUITING
Bronx
Roswell Park Cancer Institute
RECRUITING
Buffalo
Ohio
Children's Hospital Medical Center of Akron
RECRUITING
Akron
Cleveland Clinic Foundation
RECRUITING
Cleveland
Rainbow Babies and Childrens Hospital
RECRUITING
Cleveland
Dayton Children's Hospital
RECRUITING
Dayton
Oklahoma
University of Oklahoma Health Sciences Center
NOT_YET_RECRUITING
Oklahoma City
Oregon
Oregon Health and Science University
RECRUITING
Portland
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Children's Hospital of Pittsburgh of UPMC
RECRUITING
Pittsburgh
Rhode Island
Rhode Island Hospital
RECRUITING
Providence
South Carolina
Prisma Health Richland Hospital
RECRUITING
Columbia
BI-LO Charities Children's Cancer Center
RECRUITING
Greenville
South Dakota
Sanford USD Medical Center - Sioux Falls
RECRUITING
Sioux Falls
Tennessee
East Tennessee Childrens Hospital
RECRUITING
Knoxville
Texas
Dell Children's Medical Center of Central Texas
RECRUITING
Austin
UT Southwestern/Simmons Cancer Center-Dallas
RECRUITING
Dallas
Cook Children's Medical Center
RECRUITING
Fort Worth
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
RECRUITING
Houston
M D Anderson Cancer Center
RECRUITING
Houston
University of Texas Health Science Center at San Antonio
RECRUITING
San Antonio
Washington
Seattle Children's Hospital
RECRUITING
Seattle
Providence Sacred Heart Medical Center and Children's Hospital
RECRUITING
Spokane
Wisconsin
Marshfield Medical Center-Marshfield
SUSPENDED
Marshfield
Time Frame
Start Date: 2023-11-30
Estimated Completion Date: 2029-06-30
Participants
Target number of participants: 330
Treatments
Observational (biospecimen collection, clinical evaluation)
Patients undergo an optional saliva/buccal swab in part 1 and clinical assessment in part 2 of the study. Patients may then undergo blood sample collection in part 3 of the study.
Sponsors
Leads: Children's Oncology Group

This content was sourced from clinicaltrials.gov