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

• Sponsor: National Cancer Institute (NCI) (NIH)
• Overall Status: Recruiting
• CT.gov ID: NCT02610413
• Collaborator: (none)
• Enrollment: 354
• Location: 1
• Anticipated Duration (Months): 1029.3
• Patients Per Site Per Month: 0.3

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 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.

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 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 Design

• Study Type: Observational
• Anticipated Enrollment: 354 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: Exploratory Next Generation Sequencing to Identify Causative Variants for Bevacizumab-Induced Hypertension 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 bevacizumab-induced hypertension [Baseline]

   Burden analysis will be used.

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 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

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: NCT02610413
• Other Study ID Numbers: NCI-2013-02289; NCI-2013-02289; ECOG-E5103T2; E5103T2; E5103T2; U10CA180820
• First Posted: Nov 20, 2015
• Last Update Posted: Mar 28, 2022
• Last Verified: Mar 1, 2022

• Additional relevant MeSH terms: Breast Neoplasms; Hypertension

Study Results

No Results Posted as of Mar 28, 2022