Clinical trial · Observational
Study of Cisplatin-Induced Peripheral Neuropathy in Patients With Germ Cell Tumor
A Study of the Natural History of Cisplatin-Induced Peripheral Neuropathy in Patients With Germ Cell Tumor
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Testicular Germ Cell Tumor | Testicular Germ Cell Tumor | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EORTC QLQ-CIPN20 | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Incidence of neuropathy
- timeFrame
- 18 months
- description
- As measured by cumulative EORTC CIPN-20 scores
Secondary outcomes (1)
- measure
- Change in neuropathy
- timeFrame
- 18 months
- description
- As measured by change in EORTC CIPN-20 scores
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 15 Years
Show eligibility criteria text
Inclusion criteria: 1. 15 years of age or older at the time of informed consent 2. Have a confirmed pathologic and/or by tumor marker diagnosis of testicular or extragonadal germ cell cancer. 3. Provide written informed consent and assent (if applicable). 4. Ability to complete questionnaire(s) in English by themselves or with assistance. 5. Willing to provide a 10 mL blood sample for future DNA testing 6. Planning to receive at least 3 cycles of cisplatin (20 mg/m2/d for 5 days) based chemotherapy. 7. Must agree to continued clinical follow-up at the study cancer center. Exclusion criteria: 1. Diagnosis (current or previous) of peripheral neuropathy (from diabetes or other causes). 2. Previous exposure to neurotoxic chemotherapy drugs including taxanes, platinum agents, vinca alkaloids, or epothilones. 3. Salvage chemotherapy treatment or bone marrow transplant. Salvage chemotherapy is defined as any treatment after relapse of the disease following initial chemotherapy treatment.
References
Publications (1)
- DERIVEDAlbany C, Dockter T, Wolfe E, Le-Rademacher J, Wagner-Johnston N, Einhorn L, Lafky JM, Smith E, Pachman D, Staff N, Ma C, Loprinzi CL, Costello BA. Cisplatin-associated neuropathy characteristics compared with those associated with other neurotoxic chemotherapy agents (Alliance A151724). Support Care Cancer. 2021 Feb;29(2):833-840. doi: 10.1007/s00520-020-05543-5. Epub 2020 Jun 4. PMID 32500206