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

Recruiting

• Conditions: Breast Carcinoma; Neuropathy
• Interventions: Other: Laboratory Biomarker Analysis

• Registration Number: NCT02610439
• Lead Sponsor: National Cancer Institute (NCI)

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2014-03-25
• Study First Submitted: 2015-11-19
• Study First Submitted QC: 2015-11-19
• Study First Posted: 2015-11-20
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-27
• Primary Completion: 2100-01-01
• Study Completion: 2100-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 575

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ancillary-Correlative (whole exome sequencing)	Laboratory Biomarker Analysis	Previously collected germline DNA samples are analyzed via whole exome sequencing.

Primary Outcome Measures

Name	Time	Method
Identification of rare coding variants of large effect that predict the risk of peripheral neuropathy	Baseline	Assess by Burden analysis.

Trial Locations

Locations (1)

Eastern Cooperative Oncology Group; 🇺🇸 Boston, Massachusetts, United States