Assessment of Paclitaxel-Induced Neuropathy

June 6, 2025 updated by: University of Chicago

Validation of a Polygenic Neurotoxicity Risk Score in Patients With Unusually Severe Paclitaxel-Induced Neuropathy

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

43

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

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Comprehensive Cancer Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients treated with paclitaxel

Description

Inclusion Criteria (Severe Toxicity Group):

  • Diagnosis of cancer (including, but not limited to, breast and ovarian cancer)
  • Females aged 18 and older
  • History of grade 3 or higher peripheral neurotoxicity, any neuromotor, neurocortical, or neurocerebellar toxicity, myalgias or arthralgias refractory to non-steroidal anti-inflammatory drugs and steroids, ong-term persistence (> 6 months) of grade 2 or higher peripheral neuropathy, or other unusually severe neurotoxicity approved for inclusion in study by Principal Investigator after completion of paclitaxel chemotherapy regimen or history of peripheral neuropathy that required treatment with narcotics or grade 2 or higher peripheral neuropathy after only 1 to 2 doses of paclitaxel.

Inclusion Criteria (Control Group):

  • 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

Exclusion Criteria :

  • 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)

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with severe neuropathy
Patients with severe neuropathy after treatment with paclitaxel. Blood samples and patient questionnaires will be collected.
Other: Blood Collection
Other: Patient Questionnaires
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
Other: Blood Collection
Other: Patient Questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of polygenic risk score
Time Frame: 2 years
Patients will be assessed for neuropathy symptoms and blood samples will be analyzed to detect potential predictive markers
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Gini Fleming, MD, University of Chicago

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)

August 29, 2013

Primary Completion (Estimated)

May 19, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

September 25, 2013

First Submitted That Met QC Criteria

September 27, 2013

First Posted (Estimated)

September 30, 2013

Study Record Updates

Last Update Posted (Actual)

June 8, 2025

Last Update Submitted That Met QC Criteria

June 6, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • IRB13-0775

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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