Whole Exome Sequencing in Finding Causative Variants in Germline DNA Samples From Patients With Hypertension Receiving Bevacizumab for Breast Cancer

Recruiting

• Conditions: Breast Carcinoma
• Interventions: Other: Laboratory Biomarker Analysis

• Registration Number: NCT02610413
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

This research trial studies whole exome sequencing in finding causative variants in germline deoxyribonucleic acid (DNA) samples from patients with hypertension receiving bevacizumab for breast cancer. Studying samples of germline DNA in the laboratory from patients with hypertension receiving bevacizumab for breast cancer may help doctors learn about changes that occur in DNA and identify biomarkers related to hypertension.

Detailed Description

PRIMARY OBJECTIVES:

I. To identify, using next generation sequencing, rare variants of large effect size that impact the risk of hypertension in patients from the clinical trial Eastern Cooperative Oncology Group (ECOG)-5103 (E5103).

OUTLINE:

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

Study Timeline

• Study Start: 2014-03-25
• Study First Submitted: 2015-11-19
• Study First Submitted QC: 2015-11-19
• Study First Posted: 2015-11-20
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-27
• Primary Completion: 2100-01-01
• Study Completion: 2100-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 354

Inclusion Criteria

• European American patients with deoxyribonucleic acid (DNA) available and designated case or control
• Patients who developed grade 3-4 bevacizumab-induced hypertension during their treatment with bevacizumab
• Patients who did not develop hypertension following a full course of treatment with bevacizumab

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-Correlative (whole exome sequencing)	Laboratory Biomarker Analysis	Previously collected germline DNA samples are analyzed via whole exome sequencing.

Primary Outcome Measures

Name	Time	Method
Identification of rare coding variants of large effect that predict the risk of bevacizumab-induced hypertension	Baseline	Burden analysis will be used.

Trial Locations

Locations (1)

Eastern Cooperative Oncology Group; 🇺🇸 Boston, Massachusetts, United States