NCT01953159Active, not recruiting
Assessment of Paclitaxel-Induced Neuropathy
Validation of a Polygenic Neurotoxicity Risk Score in Patients With Unusually Severe Paclitaxel-Induced Neuropathy
Source: ClinicalTrials.gov · Last updated 8 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 43 (actual)
- First submitted
- 25 Sept 2013
- Start date
- Aug 2013
- Primary completion date
- May 2027
- Lead sponsor
- University of Chicago
- Diseases
- Ovarian cancer
- NCT number
- NCT01953159
What you commit to
- Study type: Observational
- Participants enrolled: 43
- From Aug 2013 to the primary completion date, May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Poorly controlled or insulin-dependent diabetes or other condition likely to predispose to neurotoxicity (alcoholism, Charcot-Marie-Tooth disease)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Chicago Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.