MedTrace Logo

Study of Cisplatin-Induced Peripheral Neuropathy in Patients With Germ Cell Tumor

NCT02677727 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 54

Last updated 2020-09-22

No results posted yet for this study

Summary

This is a prospective observational study investigating the incidence, characteristics of, and change in chronic neuropathy symptoms related to cisplatin using the EORTC CIPN-20 instrument. Approximately 60 patients will be collected for this study. The duration of this study will be up to 18 months for each patient. This study will complement a current R01 funded trial (Platinum Study) which evaluates the genetic predisposition of chronic neuropathy after 12 months of chemotherapy. However, although the platinum study evaluates a similar patient population, it does not evaluate the natural history of platinum induced neuropathy during active treatment and the first 12 months post chemotherapy. This trial will fill this gap and add to the investigators knowledge for both natural history and genetic predisposition of platinum neurotoxicity.

Conditions

  • Testicular Germ Cell Tumor

Interventions

OTHER

EORTC QLQ-CIPN20

EORTC QLQ-CIPN20 is a 20-item chemotherapy-induced peripheral neuropathy-specific questionnaire which includes three scales assessing sensory (9 items: #31-36, 39, 40, 48), motor (8 items: #37, 38, 41-45, 49), and autonomic (3 items: #46, 47, 50) symptoms and functioning with each item measured on a 1-4 scale (1 - not at all; 4 - very much).

Sponsors & Collaborators

  • Mayo Clinic

    collaborator OTHER

  • Costantine Albany

    lead OTHER

Principal Investigators

  • Costantine Albany, MD · Indiana University School of Medicine, Indiana University Simon Cancer Center

Eligibility

Min Age
15 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-01
Primary Completion
2020-06-17
Completion
2020-06-17

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02677727 on ClinicalTrials.gov