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

Exploratory Next Generation Sequencing to Identify Causative Variants for Therapy-Induced Congestive Heart Failure From Breast Cancer Study E5103 Germline DNA Samples

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02610426

Enrollment

162

Registered

2015-11-20

Start date

2014-03-25

Completion date

2100-01-01

Last updated

2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Carcinoma

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.

Interventions

OTHERLaboratory Biomarker Analysis

Correlative studies

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Identification of rare coding variants of large effect that predict the risk of CHF	Baseline	Assessed by burden analysis.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORBryan P Schneider

Eastern Cooperative Oncology Group

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026