Whole Exome Sequencing for Peripheral Neuropathy with Paclitaxel in Breast Cancer

This research study is looking at germline DNA (your inherited genetic material) from patients who received paclitaxel for breast cancer. The goal is to find specific genetic changes (variants) that might explain why some patients develop peripheral neuropathy (nerve damage that can cause pain, numbness, or tingling) during or after their paclitaxel treatment, while others do not. Researchers will analyze DNA samples from European American and African American patients who either developed significant peripheral neuropathy or did not. By studying these DNA samples, doctors hope to identify biomarkers (biological indicators) that could predict a patient's risk of developing this side effect.

Study design
This is an observational study involving 575 participants. It aims to identify genetic variants related to peripheral neuropathy risk.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, identification of rare coding variants, is measured at Baseline.

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NCT02610439

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

Recruiting
Not specifiedAll AgesObservational
National Cancer Institute (NCI)
~575 participants
Updated 2026-03-27 on ClinicalTrials.gov
What's tested:Laboratory Biomarker Analysis

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Identification of rare coding variants of large effect that predict the risk of peripheral neuropathy
Measured over Baseline
Breast Carcinoma
Neuropathy
1 sites across 1 states
Massachusetts1
  • Bryan P Schneider · PRINCIPAL_INVESTIGATOR · Eastern Cooperative Oncology Group

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Eligibility criteria

Inclusion

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
  • Identification of rare coding variants of large effect that predict the risk of peripheral neuropathyBaseline

    Assess by Burden analysis.