NCT02610439

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
575

participants targeted

Target at P75+ for all trials

Timeline
896mo left

Started Mar 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Mar 2014Jan 2100

Study Start

First participant enrolled

March 25, 2014

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 19, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
84.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2100

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2100

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

85.8 years

First QC Date

November 19, 2015

Last Update Submit

March 25, 2026

Conditions

Breast CarcinomaNeuropathy

Outcome Measures

Primary Outcomes (1)

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

    Assess by Burden analysis.

    Baseline

Study Arms (1)

Ancillary-Correlative (whole exome sequencing)

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

Other: Laboratory Biomarker Analysis

Interventions

Laboratory Biomarker AnalysisOTHER

Correlative studies

Ancillary-Correlative (whole exome sequencing)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eastern Cooperative Oncology Group

Boston, Massachusetts, 02215, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Bryan P Schneider

    Eastern Cooperative Oncology Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2015

First Posted

November 20, 2015

Study Start

March 25, 2014

Primary Completion (Estimated)

January 1, 2100

Study Completion (Estimated)

January 1, 2100

Last Updated

March 27, 2026

Record last verified: 2026-03

Locations

US(1)