Whole Exome Sequencing in Finding Causative Variants in Germline DNA Samples From Patients With Congestive Heart Failure Receiving Therapy for Breast Cancer

Recruiting

• Conditions: Breast Carcinoma
• Interventions: Other: Laboratory Biomarker Analysis

• Registration Number: NCT02610426
• Lead Sponsor: National Cancer Institute (NCI)

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.

Study Timeline

• Study Start: 2014-03-25
• Study First Submitted: 2015-11-19
• Study First Submitted QC: 2015-11-19
• Study First Posted: 2015-11-20
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-27
• Primary Completion: 2100-01-01
• Study Completion: 2100-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 162

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-Correlative (whole exome sequencing)	Laboratory Biomarker Analysis	Previously collected germline DNA samples are analyzed via whole exome sequencing.

Primary Outcome Measures

Name	Time	Method
Identification of rare coding variants of large effect that predict the risk of CHF	Baseline	Assessed by burden analysis.

Trial Locations

Locations (1)

Eastern Cooperative Oncology Group; 🇺🇸 Boston, Massachusetts, United States