Assessment of Paclitaxel-Induced Neuropathy
Validation of a Polygenic Neurotoxicity Risk Score in Patients With Unusually Severe Paclitaxel-Induced Neuropathy
1 other identifier
observational
43
1 country
1
Brief Summary
The purpose of this study is to collect clinical data, blood samples, and self reported symptoms from patients that experience unusually severe neuropathy after treatment with paclitaxel. This data will be used to develop predictive markers for neuropathy. Blood samples will be used to create induced pluripotent stem (iPS) cells and eventually artificial nerve cells to be used to study neuropathy in the lab.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 29, 2013
CompletedFirst Submitted
Initial submission to the registry
September 25, 2013
CompletedFirst Posted
Study publicly available on registry
September 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 19, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
June 8, 2025
June 1, 2025
13.7 years
September 25, 2013
June 6, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Validation of polygenic risk score
Patients will be assessed for neuropathy symptoms and blood samples will be analyzed to detect potential predictive markers
2 years
Study Arms (2)
Patients with severe neuropathy
Patients with severe neuropathy after treatment with paclitaxel. Blood samples and patient questionnaires will be collected.
Patients without neuropathy
Patients will be enrolled to this cohort and matched to a specified subject with neurotoxicity based on age (within 10 years), tumor type, chemotherapy regimen or total paclitaxel dosage, race, and ethnicity
Interventions
Eligibility Criteria
Patients treated with paclitaxel
You may qualify if:
- Diagnosis of cancer (including, but not limited to, breast and ovarian cancer)
- Females aged 18 and older
- History of no neurotoxicity (grade 0) after completion of a standard paclitaxel-containing chemotherapy regimen
- Females age 18 and older
- Matched to a specified subject with neurotoxicity based on age (within 10 years), tumor type, chemotherapy regimen or total paclitaxel dosage, race, and ethnicity
You may not qualify if:
- Treatment with other severely neurotoxic chemotherapy (i.e. cisplatin) prior to or concomitantly with paclitaxel. Carboplatin therapy is allowed.
- Presence of peripheral neuropathy prior to paclitaxel therapy
- Poorly controlled or insulin-dependent diabetes or other condition likely to predispose to neurotoxicity (alcoholism, Charcot-Marie-Tooth disease)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, 60637, United States
Biospecimen
Whole blood, DNA,Peripheral Blood Mononuclear Cells (PBMC)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gini Fleming, MD
University of Chicago
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2013
First Posted
September 30, 2013
Study Start
August 29, 2013
Primary Completion (Estimated)
May 19, 2027
Study Completion (Estimated)
December 1, 2027
Last Updated
June 8, 2025
Record last verified: 2025-06