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

NCT ID: NCT02610426

Last Updated: 2025-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

162 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-25

Study Completion Date

2100-01-01

Brief Summary

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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

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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.

Conditions

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Breast Carcinoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Ancillary-Correlative (whole exome sequencing)

Previously collected germline DNA samples are analyzed via whole exome sequencing.

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Interventions

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Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bryan P Schneider

Role: PRINCIPAL_INVESTIGATOR

Eastern Cooperative Oncology Group

Locations

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Eastern Cooperative Oncology Group

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Bryan P. Schneider

Role: primary

317-274-6473

Other Identifiers

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NCI-2013-02291

Identifier Type: REGISTRY

Identifier Source: secondary_id

ECOG-E5103T3

Identifier Type: -

Identifier Source: secondary_id

E5103T3

Identifier Type: OTHER

Identifier Source: secondary_id

E5103T3

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180820

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2013-02291

Identifier Type: -

Identifier Source: org_study_id

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