Whole Exome Sequencing in Finding Causative Variants in G... | NCT02610426

ID	Type	Description	Link
NCI-2013-02291	Registry Identifier	CTRP (Clinical Trial Reporting Program)
ECOG-E5103T3
E5103T3	Other Identifier	Eastern Cooperative Oncology Group
E5103T3	Other Identifier	CTEP
U10CA180820	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 25, 2014Actual

Primary Completion Date

Jan 1, 2100Estimated

Completion Date

Jan 1, 2100Estimated

First Submitted Date

Nov 19, 2015

First Submission Date that Met QC Criteria

Nov 19, 2015

First Posted Date

Nov 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 25, 2026

Last Update Posted Date

Mar 27, 2026Actual

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

162Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ancillary-Correlative (whole exome sequencing)		Previously collected germline DNA samples are analyzed via whole exome sequencing.	Other: Laboratory Biomarker Analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Laboratory Biomarker Analysis	Other	Correlative studies	Ancillary-Correlative (whole exome sequencing)

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with breast cancer enrolled on E5103 with or without congestive heart failure.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bryan P Schneider	Eastern Cooperative Oncology Group	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eastern Cooperative Oncology Group	Recruiting	Boston	Massachusetts	02215	United States

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases