Recruiting

Whole Exome Sequencing

Sponsor:

National Cancer Institute (NCI)

Code:

NCT02610426

Conditions

Breast Carcinoma

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Laboratory Biomarker Analysis

Study Details

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.

Conditions

Breast Carcinoma

Study ID

NCT02610426

Start date

Mar 25, 2014

Status verified date

Mar, 2026

Completion date

Jan 1, 2100

Anticipated

Primary completion date

Jan 1, 2100

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

162 participants

Anticipated

Interventions and Outcome Measures

Arms

Ancillary-Correlative (whole exome sequencing)

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

Interventions

Laboratory Biomarker Analysis

Correlative studies

Primary outcome measure

  • Identification of rare coding variants of large effect that predict the risk of CHF [ Time Frame: Baseline ]

Central Contacts and Locations

Locations

Eastern Cooperative Oncology Group

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Bryan P. Schneider

317-274-6473bpschnei@iupui.edu

Principal Investigator:

Bryan P. Schneider

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-03-27.