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NCT02610439 Clinical Trial

Whole Exome Sequencing in Finding Causative Variants in Germline DNA Samples From Patients With Peripheral Neuropathy Receiving Paclitaxel for Breast Cancer

Breast Carcinoma Clinical Trial

Official title:
Exploratory Next Generation Sequencing to Identify Causative Variants for Taxane-Induced Peripheral Neuropathy From Breast Cancer Study E5103 Germline DNA Samples

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02610439
Other study ID # NCI-2013-02292
Secondary ID NCI-2013-02292EC
Status Recruiting
Phase
First received
Last updated
Start date March 25, 2014
Est. completion date January 1, 2100

Study information
Verified date December 2023
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This research trial studies whole exome sequencing in finding causative variants in germline deoxyribonucleic acid (DNA) samples from patients with peripheral neuropathy receiving chemotherapy for breast cancer. Studying samples of germline DNA in the laboratory from patients with peripheral neuropathy receiving paclitaxel for breast cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to peripheral neuropathy.

Description:

PRIMARY OBJECTIVES: I. To identify, using next generation sequencing, rare variants of large effect size that impact the risk of peripheral neuropathy in patients of African and European descent in the clinical trial ECOG-5103 (E5103). OUTLINE: Previously collected germline DNA samples are analyzed via whole exome sequencing.

Recruitment information / eligibility
Status Recruiting
Enrollment 575
Est. completion date January 1, 2100
Est. primary completion date January 1, 2100
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - European American patients with DNA available and designated case or control - African American patients with DNA available and designated case or control status - Patients who developed grade 2-4 for African American (AA) and grade 3-4 for European American (EA) peripheral neuropathy during their treatment with paclitaxel and who did not develop peripheral neuropathy following a full course of treatment with paclitaxel

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Laboratory Biomarker Analysis
Correlative studies

Locations
Country Name City State
United States Eastern Cooperative Oncology Group Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Identification of rare coding variants of large effect that predict the risk of peripheral neuropathy Assess by Burden analysis. Baseline
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