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NCT05702645 · ClinicalTrials.gov registry record

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

A clinical trial of Down Syndrome and Myeloid Leukemia Associated With Down Syndrome, sponsored by Children's Oncology Group.

Recruiting
Registry status
330
Enrollment target
20
Study locations

NCT05702645: Recruiting study of Down Syndrome and Myeloid Leukemia Associated With Down Syndrome, sponsored by Children's Oncology Group.

NCT05702645 is a study of Down Syndrome and Myeloid Leukemia Associated With Down Syndrome that is actively recruiting participants, run by Children's Oncology Group. The registered enrollment target is 330 participants, below the 2,466-participant average among 54 other Down Syndrome trials with a reported enrollment target (87% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05702645, a study of Down Syndrome and Myeloid Leukemia Associated With Down Syndrome, is actively recruiting participants, sponsored by Children's Oncology Group.

RECRUITING
Registry status
330 participants
Enrollment target
20
Study locations

Study 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.

Primary Outcome

Summary statistics will be used to characterize the study populations on CHC outcomes. Quantitative data (number of comorbidities) will be summarized using descriptive statistics and correlational techniques. Will use pooled logistic regression to estimate overall response, 95% confidence interval (CI), and p-values for association of acute leukemia (AL) diagnosis with medical record-verified CHC, agnostic of time to CHC. Will use stratified Cox models to refine associations of AL diagnosis with

Conditions Studied

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

Interventions

  • PROCEDURE Biospecimen Collection
  • OTHER Survey Administration
  • OTHER Questionnaire Administration
  • OTHER Clinical Evaluation
  • OTHER Neurocognitive Assessment

Study Locations (20)

California

  • Valley Children's Hospital - Madera
  • UCSF Benioff Children's Hospital Oakland - Oakland
  • Kaiser Permanente-Oakland - Oakland
  • University of California Davis Comprehensive Cancer Center - Sacramento
  • Rady Children's Hospital - San Diego - San Diego
  • UCSF Medical Center-Mission Bay - San Francisco

Florida

  • Golisano Children's Hospital of Southwest Florida - Fort Myers
  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital - Hollywood
  • Nemours Children's Clinic-Jacksonville - Jacksonville
  • Nemours Children's Hospital - Orlando
  • Nemours Children's Clinic - Pensacola - Pensacola
  • Saint Joseph's Hospital/Children's Hospital-Tampa - Tampa

Georgia

  • Children's Healthcare of Atlanta - Arthur M Blank Hospital - Atlanta
  • Augusta University Medical Center - Augusta

Alabama

  • Children's Hospital of Alabama - Birmingham

Arizona

  • Phoenix Childrens Hospital - Phoenix

Connecticut

  • Yale University - New Haven

Delaware

  • Alfred I duPont Hospital for Children - Wilmington

Hawaii

  • Kapiolani Medical Center for Women and Children - Honolulu

Trial Details

FieldValue
Enrollment Target 330 participants
Start Date 2023-11-30
Est. Completion 2029-06-30
Children's Oncology Group

342 total trials

What NCT05702645 shows while recruiting

NCT05702645 is an observational study that tracks outcomes without assigning an intervention. The registered 330 participants enrollment target is mid-sized for trials with a published cap, below the 2,466-participant average among 54 other Down Syndrome trials with a reported enrollment target (87% lower).

The record links to 3 conditions, with Down Syndrome appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT05702645 names 20 study sites across 9 states, led by California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT05702645 about?

NCT05702645 is a clinical study titled "A Study to Learn More About the Health of Persons With Down Syndrome After Treatment for Acute Leukemia". 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 l...

What is the current status of trial NCT05702645?

This trial is currently recruiting. The enrollment target is 330 participants. The study started on 2023-11-30. Estimated completion is 2029-06-30.

What conditions does trial NCT05702645 study?

This clinical trial studies the following conditions: Down Syndrome, Myeloid Leukemia Associated With Down Syndrome, B Acute Lymphoblastic Leukemia Associated With Down Syndrome.

What interventions are being tested in trial NCT05702645?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Survey Administration (OTHER), Questionnaire Administration (OTHER), Clinical Evaluation (OTHER), Neurocognitive Assessment (OTHER).

Who is sponsoring clinical trial NCT05702645?

This trial is sponsored by Children's Oncology Group, which has 342 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05702645 being conducted?

This trial has 20 study locations across Alabama, Arizona, California, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Down Syndrome

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05702645's enrollment target sits among peer trials

330 14th of 54 higher than 41 of 54 other Down Syndrome trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Down Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05702645

Source: ClinicalTrials.gov NCT05702645, the US trial registry maintained by the National Library of Medicine. NCT05702645 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.