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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorNational Cancer Institute (NCI)

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

Patients with breast cancer enrolled on E5103 with or without peripheral neuropathy.

Trial design

Design model

Case-control

Time perspective

Retrospective

Treatments tested in this trial

  • Laboratory Biomarker Analysis

    Other intervention

    Correlative studies

Treatment groups

575 Participants
are divided into 1 treatment group
Group A: Ancillary-Correlative (whole exome sequencing)1 intervention

Trial outcomes

Primary outcomes

1

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

Assess by Burden analysis.

Time frame
Baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.