Recruiting

Whole Exome Sequencing

Sponsor:

National Cancer Institute (NCI)

Code:

NCT02610439

Conditions

Breast Carcinoma

Neuropathy

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Laboratory Biomarker Analysis

Study Details

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.

Conditions

Breast Carcinoma

Neuropathy

Study ID

NCT02610439

Start date

Mar 25, 2014

Status verified date

Mar, 2026

Completion date

Jan 1, 2100

Anticipated

Primary completion date

Jan 1, 2100

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

575 participants

Anticipated

Interventions and Outcome Measures

Arms

Ancillary-Correlative (whole exome sequencing)

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

Interventions

Laboratory Biomarker Analysis

Correlative studies

Primary outcome measure

  • Identification of rare coding variants of large effect that predict the risk of peripheral neuropathy [ Time Frame: Baseline ]

Central Contacts and Locations

Locations

Eastern Cooperative Oncology Group

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Bryan P. Schneider

317-274-6473bpschnei@iupui.edu

Principal Investigator:

Bryan P. Schneider

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-03-27.