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NCT Number: NCT02610413

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Eastern Cooperative Oncology Group

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Location contact

Bryan P. Schneider

CONTACT

[email protected]

317-274-6473

Bryan P. Schneider

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laboratory biomarker analysis

Other

Correlative studies

Primary outcomes

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

    Time frame: Baseline

    Burden analysis will be used.

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2100
Study completion
2100
First posted
Nov 20, 2015
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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