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

National Cancer Institute (NCI)

Status: Enrolling

Conditions: Neuropathy; Breast Carcinoma

Treatments: Other: Laboratory Biomarker Analysis

Study type: Observational

Funder types: NIH

Identifiers

NCT02610439

NCI-2013-02292 (Registry Identifier)

U10CA180820 (U.S. NIH Grant/Contract)

E5103T4 (Other Identifier)

ECOG-E5103T4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 575 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

575 participants in 1 patient group

Ancillary-Correlative (whole exome sequencing)

Description:

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

Treatment:

Other: Laboratory Biomarker Analysis