Whole Exome Sequencing in Finding Causative Variants in Germline DNA Samples From Patients With Peripheral Neuropathy Receiving Paclitaxel for Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Laboratory Biomarker Analysis.
- Who it may be relevant to
- Registry conditions: Breast Carcinoma, Neuropathy. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Exploratory Next Generation Sequencing to Identify Causative Variants for Taxane-Induced Peripheral Neuropathy From Breast Cancer Study E5103 Germline DNA Samples
Overview
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.
Interventions
- Other Laboratory Biomarker Analysis
Correlative studies
Primary outcome measures
- Identification of rare coding variants of large effect that predict the risk of peripheral neuropathy [Time frame: Baseline]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Eastern Cooperative Oncology Group — Boston
Identifiers
NCT: NCT02610439 · NCI-2013-02292 · NCI-2013-02292 · ECOG-E5103T4 · E5103T4 · E5103T4 · U10CA180820