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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

6 Years - 39 Years

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Patients undergo saliva/buccal and blood sample collection
• Clinical Evaluation — OTHER
  Undergo a clinical assessment
• Neurocognitive Assessment — OTHER
  Undergo neurocognitive assessment
• Questionnaire Administration — OTHER
  Ancillary studies
• Survey Administration — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Nov 30, 2023

Status verified

Apr 2026

Primary completion

Jun 30, 2029

Completion

Jun 30, 2029

Study Design

Enrollment

330 participants (estimated)

Arms

• Arm: 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 with DS-ALL may then undergo blood sample collection and neurocognitive assessment in part 3 of the study.

Primary Outcome Measure

Prevalence, type, and severity of chronic health conditions (CHC) [ Time Frame: Up to study completion ]

Locations (69)

Find similar trials in Birmingham, AL

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