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Observational (blood samples, surveys, MRI, record review) for Cardiovascular Disease

N/A
Recruiting
Led By Robert J Hayashi
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 1 year
Awards & highlights

Summary

This study assesses how blood cell growth patterns (clonal hematopoiesis), relates to heart health or cardiovascular disease (CVD) after treatment in patients with Hodgkin lymphoma. In some patients, cancer treatment at a young age may lead to later complications, including problems with heart health. Checking for blood cell growth patterns called therapy-related clonal hematopoiesis (t-CH) can help predict who might be at risk for heart health problems after Hodgkin lymphoma treatment. If doctors know who may be at greater risk for developing later heart complications, then they can more closely monitor those patients to prevent or detect heart complications early.

Eligible Conditions
  • Cardiovascular Disease
  • Clonal Hematopoiesis
  • Hodgkin's Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective signs of CVD
Proportion of t-CH for patients without CVD after Hodgkin Lymphoma therapy
Proportion of t-CH with mutations for patients with CVD after Hodgkin Lymphoma therapy
+2 more
Secondary study objectives
Association between the presence of CVD and individual variables
Expansion of CH
Other study objectives
Effect of therapy-related clonal hematopoiesis on cardiovascular disease
Patient characteristics and treatments
Prevalence and nature of CVD, CH and CH with mutations associated with cardiovascular disease

Trial Design

1Treatment groups
Experimental Treatment
Group I: Observational (blood samples, surveys, MRI, record review)Experimental Treatment4 Interventions
Patients undergo collection of blood samples, complete surveys, and undergo cardiac MRI on study. Patients also have their medical records reviewed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2020
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160

Find a Location

Who is running the clinical trial?

Children's Oncology GroupLead Sponsor
457 Previous Clinical Trials
239,600 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,770 Total Patients Enrolled
Robert J HayashiPrincipal InvestigatorChildren's Oncology Group
~153 spots leftby Oct 2028