- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02610439
Whole Exome Sequencing in Finding Causative Variants in Germline DNA Samples From Patients With Peripheral Neuropathy Receiving Paclitaxel for Breast Cancer
December 23, 2023 updated by: National Cancer Institute (NCI)
Exploratory Next Generation Sequencing to Identify Causative Variants for Taxane-Induced Peripheral Neuropathy From Breast Cancer Study E5103 Germline DNA Samples
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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
Enrollment (Estimated)
575
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02215
- Recruiting
- Eastern Cooperative Oncology Group
-
Contact:
- Bryan P. Schneider
- Phone Number: 317-274-6473
- Email: bpschnei@iupui.edu
-
Principal Investigator:
- Bryan P. Schneider
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with breast cancer enrolled on E5103 with or without peripheral neuropathy.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Ancillary-Correlative (whole exome sequencing)
Previously collected germline DNA samples are analyzed via whole exome sequencing.
|
Correlative studies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Identification of rare coding variants of large effect that predict the risk of peripheral neuropathy
Time Frame: Baseline
|
Assess by Burden analysis.
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bryan P Schneider, Eastern Cooperative Oncology Group
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 25, 2014
Primary Completion (Estimated)
January 1, 2100
Study Completion (Estimated)
January 1, 2100
Study Registration Dates
First Submitted
November 19, 2015
First Submitted That Met QC Criteria
November 19, 2015
First Posted (Estimated)
November 20, 2015
Study Record Updates
Last Update Posted (Estimated)
December 27, 2023
Last Update Submitted That Met QC Criteria
December 23, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NCI-2013-02292 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- U10CA180820 (U.S. NIH Grant/Contract)
- ECOG-E5103T4
- E5103T4 (Other Identifier: CTEP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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