RecruitingNCT05702645

A Study to Learn More About the Health of Persons With Down Syndrome After Treatment for Acute Leukemia

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

Sponsor

Children's Oncology Group

Enrollment

330 participants

Start Date

Nov 30, 2023

Study Type

OBSERVATIONAL

Conditions

B Acute Lymphoblastic Leukemia Associated With Down Syndrome Down Syndrome Myeloid Leukemia Associated With Down Syndrome

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

Min Age: 6 YearsMax Age: 39 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking the long-term health of people with Down syndrome who previously had leukemia (blood cancer) and completed treatment. Researchers want to understand how survivors are doing physically, mentally, and developmentally years after their cancer treatment ended. **You may be eligible if...** - You are between 6 and 40 years old - You have Down syndrome (any type: trisomy 21, translocation, or mosaic) - You previously had and were treated for acute leukemia (ALL or AML), including myeloid leukemia of Down syndrome - All cancer treatment was completed at least 3 years ago - You did not receive a stem cell transplant as part of your treatment **You may NOT be eligible if...** - You were only diagnosed with a temporary pre-leukemia condition (transient abnormal myelopoiesis or TAM) and not actual leukemia - You received a stem cell transplant as part of your leukemia treatment - Your treatment ended less than 3 years ago Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Patients undergo saliva/buccal and blood sample collection

OTHERClinical Evaluation

Undergo a clinical assessment

OTHERNeurocognitive Assessment

Undergo neurocognitive assessment

OTHERQuestionnaire Administration

Ancillary studies

OTHERSurvey Administration

Ancillary studies

Locations(70)

Children's Hospital of Alabama

Birmingham, Alabama, United States

Phoenix Childrens Hospital

Phoenix, Arizona, United States

Valley Children's Hospital

Madera, California, United States

UCSF Benioff Children's Hospital Oakland

Oakland, California, United States

Kaiser Permanente-Oakland

Oakland, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Rady Children's Hospital - San Diego

San Diego, California, United States

UCSF Medical Center-Mission Bay

San Francisco, California, United States

Yale University

New Haven, Connecticut, United States

Alfred I duPont Hospital for Children

Wilmington, Delaware, United States

Golisano Children's Hospital of Southwest Florida

Fort Myers, Florida, United States

Memorial Regional Hospital/Joe DiMaggio Children's Hospital

Hollywood, Florida, United States

Nemours Children's Clinic-Jacksonville

Jacksonville, Florida, United States

Nemours Children's Hospital

Orlando, Florida, United States

Nemours Children's Clinic - Pensacola

Pensacola, Florida, United States

Saint Joseph's Hospital/Children's Hospital-Tampa

Tampa, Florida, United States

Children's Healthcare of Atlanta - Arthur M Blank Hospital

Atlanta, Georgia, United States

Augusta University Medical Center

Augusta, Georgia, United States

Kapiolani Medical Center for Women and Children

Honolulu, Hawaii, United States

Lurie Children's Hospital-Chicago

Chicago, Illinois, United States

Sinai Hospital of Baltimore

Baltimore, Maryland, United States

C S Mott Children's Hospital

Ann Arbor, Michigan, United States

Children's Hospital of Michigan

Detroit, Michigan, United States

Children's Hospitals and Clinics of Minnesota - Minneapolis

Minneapolis, Minnesota, United States

University of Minnesota/Masonic Cancer Center

Minneapolis, Minnesota, United States

University of Mississippi Medical Center

Jackson, Mississippi, United States

Children's Mercy Hospitals and Clinics

Kansas City, Missouri, United States

Washington University School of Medicine

St Louis, Missouri, United States

Children's Hospital and Medical Center of Omaha

Omaha, Nebraska, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

University Medical Center of Southern Nevada

Las Vegas, Nevada, United States

Sunrise Hospital and Medical Center

Las Vegas, Nevada, United States

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, United States

Summerlin Hospital Medical Center

Las Vegas, Nevada, United States

Renown Regional Medical Center

Reno, Nevada, United States

Hackensack University Medical Center

Hackensack, New Jersey, United States

Albany Medical Center

Albany, New York, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Sanford Broadway Medical Center

Fargo, North Dakota, United States

Children's Hospital Medical Center of Akron

Akron, Ohio, United States

Rainbow Babies and Childrens Hospital

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Nationwide Children's Hospital

Columbus, Ohio, United States

Dayton Children's Hospital

Dayton, Ohio, United States

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Oregon Health and Science University

Portland, Oregon, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Children's Hospital of Pittsburgh of UPMC

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Prisma Health Richland Hospital

Columbia, South Carolina, United States

BI-LO Charities Children's Cancer Center

Greenville, South Carolina, United States

Sanford USD Medical Center - Sioux Falls

Sioux Falls, South Dakota, United States

East Tennessee Childrens Hospital

Knoxville, Tennessee, United States

Saint Jude Children's Research Hospital

Memphis, Tennessee, United States

Vanderbilt University/Ingram Cancer Center

Nashville, Tennessee, United States

Dell Children's Medical Center of Central Texas

Austin, Texas, United States

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

Cook Children's Medical Center

Fort Worth, Texas, United States

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Houston, Texas, United States

M D Anderson Cancer Center

Houston, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Seattle Children's Hospital

Seattle, Washington, United States

Providence Sacred Heart Medical Center and Children's Hospital

Spokane, Washington, United States

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Children's Hospital

London, Ontario, Canada

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NCT05702645

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