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

Status: Active_not_recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
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• 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.

• 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

Locations
United States
Illinois
University of Chicago Comprehensive Cancer Center
Chicago
Time Frame
Start Date: 2013-08-29
Completion Date: 2025-12
Participants
Target number of participants: 43
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: University of Chicago

This content was sourced from clinicaltrials.gov