Study of Cisplatin-Induced Peripheral Neuropathy in Patients With Germ Cell Tumor
Completed
Conditions studied: Testicular Germ Cell Tumor
In brief
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.
Key facts
- Study ID
- NCT02677727
- Run by
- Costantine Albany
- People needed
- 54
- Starts
- 2015-07-01
- Expected to finish
- 2020-06-17
- Last updated by the study team
- 2020-09-22
Who can join
Age: 15 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 15 years of age or older at the time of informed consent
- Have a confirmed pathologic and/or by tumor marker diagnosis of testicular or extragonadal germ cell cancer.
- Provide written informed consent and assent (if applicable).
- Ability to complete questionnaire(s) in English by themselves or with assistance.
- Willing to provide a 10 mL blood sample for future DNA testing
- Planning to receive at least 3 cycles of cisplatin (20 mg/m2/d for 5 days) based chemotherapy.
- Must agree to continued clinical follow-up at the study cancer center.
You may not qualify if…
- Diagnosis (current or previous) of peripheral neuropathy (from diabetes or other causes).
- Previous exposure to neurotoxic chemotherapy drugs including taxanes, platinum agents, vinca alkaloids, or epothilones.
- Salvage chemotherapy treatment or bone marrow transplant. Salvage chemotherapy is defined as any treatment after relapse of the disease following initial chemotherapy treatment.
Where it is running
- Indiana University Health Hospital — Indianapolis, Indiana, United States
- Indiana University Health Melvin and Bren Simon Cancer Center — Indianapolis, Indiana, United States
- Mayo Clinic Department of Medical Oncology — Rochester, Minnesota, United States
Full record on ClinicalTrials.gov
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