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Clinical Trials/NCT02610413
NCT02610413
Recruiting
Not Applicable

Exploratory Next Generation Sequencing to Identify Causative Variants for Bevacizumab-Induced Hypertension From Breast Cancer Study E5103 Germline DNA Samples

National Cancer Institute (NCI)1 site in 1 country354 target enrollmentMarch 25, 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Carcinoma
Sponsor
National Cancer Institute (NCI)
Enrollment
354
Locations
1
Primary Endpoint
Identification of rare coding variants of large effect that predict the risk of bevacizumab-induced hypertension
Status
Recruiting
Last Updated
10 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 25, 2014
End Date
January 1, 2100
Last Updated
10 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Identification of rare coding variants of large effect that predict the risk of bevacizumab-induced hypertension

Time Frame: Baseline

Burden analysis will be used.

Study Sites (1)

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