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

December 23, 2023 updated by: National Cancer Institute (NCI)

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

162

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Eastern Cooperative Oncology Group
        • Contact:
        • Principal Investigator:
          • Bryan P. Schneider

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ancillary-Correlative (whole exome sequencing)
Previously collected germline DNA samples are analyzed via whole exome sequencing.
Other: Laboratory Biomarker Analysis
Correlative studies

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Bryan P Schneider, Eastern Cooperative Oncology Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2014

Primary Completion (Estimated)

January 1, 2100

Study Completion (Estimated)

January 1, 2100

Study Registration Dates

First Submitted

November 19, 2015

First Submitted That Met QC Criteria

November 19, 2015

First Posted (Estimated)

November 20, 2015

Study Record Updates

Last Update Posted (Estimated)

December 27, 2023

Last Update Submitted That Met QC Criteria

December 23, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCI-2013-02291 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • U10CA180820 (U.S. NIH Grant/Contract)
  • ECOG-E5103T3
  • E5103T3 (Other Identifier: CTEP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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