Exploratory Next Generation Sequencing to Identify Causative Variants for Therapy-Induced Congestive Heart Failure From Breast Cancer Study E5103 Germline DNA Samples
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Carcinoma
- Sponsor
- National Cancer Institute (NCI)
- Enrollment
- 162
- Locations
- 1
- Primary Endpoint
- Identification of rare coding variants of large effect that predict the risk of CHF
- Status
- Recruiting
- Last Updated
- 10 months ago
Overview
Brief Summary
This research trial studies whole exome sequencing in finding causative variants in germline deoxyribonucleic acid (DNA) samples from patients with congestive heart failure receiving therapy for breast cancer. Studying samples of germline DNA in the laboratory from patients with congestive heart failure receiving therapy for breast cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to congestive heart failure.
Detailed Description
PRIMARY OBJECTIVES: I. To identify, using next generation sequencing, rare variants of large effect size that impact the risk of congestive heart failure (CHF) in patients from the clinical trial ECOG-5103 (E5103). OUTLINE: Previously collected germline DNA samples are analyzed via whole exome sequencing.
Investigators
Eligibility Criteria
Inclusion Criteria
- •European American patients with DNA available
- •European American patients who developed CHF and patients who did not develop CHF following a full course of treatment with an anthracycline and bevacizumab
- •African American cases (based on a drop in left ventricular ejection fraction \[LVEF\] \< 50 or a drop from baseline \> 20 points) and African American controls
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Identification of rare coding variants of large effect that predict the risk of CHF
Time Frame: Baseline
Assessed by burden analysis.