Clinical trial · Observational
Acute Changes in Endothelial Function in Germ Cell Tumor Patients Treated With Cisplatin and Untreated Germ Cell Tumor Controls
A Pilot Study Measuring Acute Changes in Endothelial Function in Germ Cell Tumor Patients Treated With Cisplatin and Untreated Germ Cell Tumor Controls
- 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)
Cisplatin is one of the most common chemotherapy drugs used to treat many different cancers, including germ cell tumors (GCT). Cisplatin is very effective in treating GCT, but there are side effects. One of the possible long-term side effects of cisplatin is thought to be heart disease. The way that cisplatin causes heart disease is not well understood. One possibility is that cisplatin may damage the inside layer of blood vessels called the endothelium. The purpose of this study is to measure changes in the endothelium that happen when patients with GCT get cisplatin chemotherapy and to compare these changes with a group of patients not receiving chemotherapy.
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 |
|---|---|---|---|
| Germ Cell Cancer | Malignant Germ Cell Tumor | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endo-PAT2000 testing | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cisplatin-Based Chemotherapy Group
- description
- GCT patients who are planned to start cisplatin-based chemotherapy will be identified within the genitourinary oncology service clinics and offered inclusion in the trial.
- interventionNames
- Other: Endo-PAT2000 testing
- label
- Surgery-Only Group
- description
- GCT patients who have been treated with surgery and who do not require chemotherapy or radiation will be used as a comparison group to confirm that there is not a significant change in endothelial function among GCT patients treated with surgery alone.
- interventionNames
- Other: Endo-PAT2000 testing
Primary outcomes (1)
- measure
- Measure the endothelial reactivity (PAT-RH) in both groups
- timeFrame
- 15 minutes
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Cisplatin-Based Chemotherapy Group * Histologically-proven diagnosis of GCT * Male * Age ≥18 * No prior exposure to chemotherapy or radiation * Planned to receive 3-4 cycles of cisplatin-based chemotherapy Surgery-Only Group * Histologically-proven diagnosis of GCT Male * Age ≥18 * Surgical management of GCT performed less than 90 days before start of study (includes orchiectomy and primary retroperitoneal lymph node dissection (RPLND)) * No prior exposure to chemotherapy or radiation Exclusion Criteria: Cisplatin-Based Chemotherapy Group * Prior exposure to chemotherapy or radiation * Known diagnosis or history of being diagnosed with vasculitis, autonomic dysfunction, coronary artery disease, or collagen-vascular disease Surgery-Only Group * Prior exposure to chemotherapy or radiation * Planned for non-surgical management with chemotherapy or radiation. * Known diagnosis or history of being diagnosed with vasculitis, autonomic dysfunction, coronary artery disease, or collagen-vascular disease.
References
Publications (0)
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