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Observational (biospecimen collection, clinical evaluation) for Down Syndrome

N/A
Recruiting
Led By Maria M Gramatges
Research Sponsored by Children's Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to study completion
Awards & highlights

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.

Eligible Conditions
  • Down Syndrome
  • B Acute Lymphoblastic Leukemia
  • Myeloid Leukemia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to study completion
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to study completion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Prevalence, type, and severity of chronic health conditions (CHC)
Secondary outcome measures
Clinical risk determinants of CHC, NP, and clinical outcomes
Health-related quality of life (HRQOL)
Post-treatment clinical outcomes
+2 more
Other outcome measures
Structural birth defects and genetic associations with etiology extending to CHC for Down syndrome acute lymphoblastic leukemia (DS-ALL)
Telomere length (TL) determined by polygenic risk score and telomere flow-fluorescence in situ hybridization (FISH) in association with outcomes from in-person NP assessment for DS-ALL

Trial Design

1Treatment groups
Experimental Treatment
Group I: Observational (biospecimen collection, clinical evaluation)Experimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1730

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,662 Previous Clinical Trials
40,925,551 Total Patients Enrolled
12 Trials studying Down Syndrome
18,619 Patients Enrolled for Down Syndrome
Children's Oncology GroupLead Sponsor
454 Previous Clinical Trials
237,610 Total Patients Enrolled
10 Trials studying Down Syndrome
11,349 Patients Enrolled for Down Syndrome
Maria M GramatgesPrincipal InvestigatorChildren's Oncology Group

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Learn More About the Health of Persons With Down Syndrome After Treatment for Acute Leukemia
2023. "A Study to Learn More About the Health of Persons With Down Syndrome After Treatment for Acute Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05702645.
All > Toronto > Spokane
~220 spots leftby Dec 2028
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