Boston, Massachusetts 02215


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

NCI-2013-02289


NCT ID:

NCT02610413


Secondary ID:

NCI-2013-02289


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

N/A


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Cancer Institute (NCI)


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

354


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Bryan P Schneider
Principal Investigator
Eastern Cooperative Oncology Group

Study Dates

Start Date:March 25, 2014
Completion Date:January 1, 2100
Completion Type:Anticipated
Primary Completion Date:January 1, 2100
Primary Completion Type:Anticipated
Verification Date:January 2020
Last Changed Date:January 2, 2020
First Received Date:November 19, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Identification of rare coding variants of large effect that predict the risk of bevacizumab-induced hypertension
Time Frame:Baseline
Safety Issues:False
Description:Burden analysis will be used.

Study Interventions

Intervention Type:Other
Name:Laboratory Biomarker Analysis
Description:Correlative studies
Arm Name:Ancillary-Correlative (whole exome sequencing)

Study Arms

Study Arm Type:Other
Arm Name:Ancillary-Correlative (whole exome sequencing)
Description:Previously collected germline DNA samples are analyzed via whole exome sequencing.

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Cancer Institute (NCI)

Samples and Retentions

Sample Retention:Samples With DNA
Description: Blood
Study Population: Patients with breast cancer enrolled on E5103 with or without hypertension
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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