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

• Sponsor: National Cancer Institute (NCI) (NIH)
• Overall Status: Recruiting
• CT.gov ID: NCT02610426
• Collaborator: (none)
• Enrollment: 162
• Location: 1
• Anticipated Duration (Months): 1029.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Carcinoma	Other: Laboratory Biomarker Analysis

Detailed Description

PRIMARY OBJECTIVES:

1. 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 Design

• Study Type: Observational
• Anticipated Enrollment: 162 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Exploratory Next Generation Sequencing to Identify Causative Variants for Therapy-Induced Congestive Heart Failure From Breast Cancer Study E5103 Germline DNA Samples
• Actual Study Start Date: Mar 25, 2014
• Anticipated Primary Completion Date: Jan 1, 2100
• Anticipated Study Completion Date: Jan 1, 2100

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Identification of rare coding variants of large effect that predict the risk of CHF [Baseline]

   Assessed by burden analysis.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Eastern Cooperative Oncology Group	Boston	Massachusetts	United States	02215

Sponsors and Collaborators

• National Cancer Institute (NCI)

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Cancer Institute (NCI)
• ClinicalTrials.gov Identifier: NCT02610426
• Other Study ID Numbers: NCI-2013-02291; NCI-2013-02291; ECOG-E5103T3; E5103T3; E5103T3; U10CA180820
• First Posted: Nov 20, 2015
• Last Update Posted: Mar 28, 2022
• Last Verified: Mar 1, 2022

• Additional relevant MeSH terms: Breast Neoplasms; Heart Failure

Study Results

No Results Posted as of Mar 28, 2022