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NCT02610439 | RECRUITING | Breast Carcinoma

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

National Cancer Institute (NCI)

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.

Condition or disease

Breast Carcinoma

Neuropathy

Intervention/treatment

Laboratory Biomarker Analysis

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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 575 participants
Official Title : Exploratory Next Generation Sequencing to Identify Causative Variants for Taxane-Induced Peripheral Neuropathy From Breast Cancer Study E5103 Germline DNA Samples
Actual Study Start Date : 2014-03-25
Estimated Primary Completion Date : 2100-01-01
Estimated Study Completion Date : 2100-01-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
Whole Exome Sequencing in Finding Causative Variants in Germline DNA Samples From Patients With Peripheral Neuropathy Receiving Paclitaxel for Breast Cancer

Location Details

NCT02610439

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Locations

RECRUITING

United States, Massachusetts

Eastern Cooperative Oncology Group

Boston, Massachusetts, United States, 02215