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OpenTrials
Active, Not Recruiting

NCT Number: NCT01953159

Assessment of 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blood collection

Other

Patient questionnaires

Other

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2027
Study completion
2027
First posted
Sep 30, 2013
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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