Germ Cell Cancer
Conditions
Keywords
Endothelial Function, Endo-PAT2000 system, 11-140
Brief summary
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.
Interventions
OTHEREndo-PAT2000 testing
Endo-PAT2000 testing is done six times during the study. Baseline Assessment Time 1 Cycle 1, Day 1 (Pre-chemotherapy)Time 2 Cycle 1, Day 1 (After 1st dose of cisplatin), Time 3 Cycle 1, Day 2 (Before second cisplatin dose of cycle 1), Time 4 Cycle 1, Day 5 (After last cisplatin dose of cycle 1), End-of-Study Assessment Time 5 (14-34 weeks from Time 1; e.g., 1-12 weeks following completion of the last cycle of first-line chemotherapy) Long-Term Follow Up Assessment Time 6 (24-30 months from Time 1)
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure the endothelial reactivity (PAT-RH) in both groups | 15 minutes | The Endo-PAT quantifies the endothelium-mediated changes in vascular tone, elicited by a 5-minute occlusion of the brachial artery (using a standard BP cuff). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identify sociodemographic | 2 years | (age, race/ethnicity) |
| Identify comorbid health conditions | 2 years | Other laboratory studies being assessed in this trial will include lipid profile, testosterone, LH, FSH, and hemoglobin A1C. These tests are being evaluated to determine if there are concurrent comorbidities |
| Measure PAT-RH index | 2 years | at Time 6 (Long-Term Follow Up Assessment) in the Cisplatin-Based Chemotherapy Group and evaluate long term changes in PATRH index. |
Countries
United States
Outcome results
None listed