Assessment of Paclitaxel-Induced Neuropathy

Active, not recruiting

• Conditions: Breast Cancer; Cancer; Ovarian Cancer
• Interventions: Other: Blood Collection; Other: Patient Questionnaires

• Registration Number: NCT01953159
• Lead Sponsor: University of Chicago

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-08-29
• Study First Submitted: 2013-09-25
• Study First Submitted QC: 2013-09-27
• Study First Posted: 2013-09-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-31
• Primary Completion: 2025-05-19
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 43

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with severe neuropathy	Blood Collection	Patients with severe neuropathy after treatment with paclitaxel. Blood samples and patient questionnaires will be collected.
Patients with severe neuropathy	Patient Questionnaires	Patients with severe neuropathy after treatment with paclitaxel. Blood samples and patient questionnaires will be collected.
Patients without neuropathy	Blood Collection	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
Patients without neuropathy	Patient Questionnaires	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

Primary Outcome Measures

Name	Time	Method
Validation of polygenic risk score	2 years	Patients will be assessed for neuropathy symptoms and blood samples will be analyzed to detect potential predictive markers

Trial Locations

Locations (1)

University of Chicago Comprehensive Cancer Center; 🇺🇸 Chicago, Illinois, United States