Study of Cisplatin-Induced Peripheral Neuropathy in Patients with Germ Cell Tumor
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-002654
NCT ID: NCT02677727
Sponsor Protocol Number: IUCRO-0502
About this study
The purpose of this study is to investigate the incidence, characteristics of, and changes in chronic neuropathy symptoms related to cisplatin and evaluate the natural history of platinum induced peripheral neuropathy during active treatment and the first 12 months post chemotherapy.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria
- 15 years of age or older at the time of informed consent
- Has 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
Exclusion Criteria
- 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
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
Contact |
Rochester, Minn.
Mayo Clinic principal investigator Brian Costello, M.D. |
Closed for enrollment |
Contact information:
Cancer Center Clinical Trials Referral Office
(855) 776-0015
|
More information
Publications
Publications are currently not available