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

NCT ID: NCT02610413

Last Updated: 2025-06-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

354 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-25

Study Completion Date

2100-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ancillary-Correlative (whole exome sequencing)

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

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Cancer Institute (NCI)

NIH

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bryan P Schneider

Role: PRINCIPAL_INVESTIGATOR

Eastern Cooperative Oncology Group

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Eastern Cooperative Oncology Group

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Bryan P. Schneider

Role: primary

317-274-6473

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCI-2013-02289

Identifier Type: REGISTRY

Identifier Source: secondary_id

ECOG-E5103T2

Identifier Type: -

Identifier Source: secondary_id

E5103T2

Identifier Type: OTHER

Identifier Source: secondary_id

E5103T2

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA180820

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2013-02289

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.