Acute Changes in Endothelial Function in Germ Cell Tumor Patients Treated With Cisplatin and Untreated Germ Cell Tumor Controls
NCT ID: NCT01453660
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
44 participants
OBSERVATIONAL
2011-10-11
2026-10-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Cisplatin-Based Chemotherapy Group
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.
Endo-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)
Surgery-Only Group
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.
Endo-PAT2000 testing
Time 1: A baseline assessment will be performed in the fasting state including Endo-PAT2000, vital signs, waist circumference, fasting blood draw, \& urine sample. This will be considered Day 1 of the study for this group of patients. Time 2 (2-5 hours from Time 1): Two to five hours after Time 1, patients will undergo assessment of blood pressure \& heart rate, including orthostatics \& Endo-PAT2000 testing. Time 5 -- End of Study visit (14-34 weeks from Time 1): At a time point 14 to 34 weeks later than Time 1 patients will undergo study testing in the fasting state. This includes Endo-PAT2000 testing, vital signs including orthostatics, waist circumference, fasting blood draw, \& urine sample. The Surgery-Only Group will not have any assessment at Time 3 (Day 2) or Time 4 (Day 5) due to logistical concerns. Long-Term Follow Up Assessment Time 6 (24-30 months following Time 1)
Interventions
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Endo-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)
Endo-PAT2000 testing
Time 1: A baseline assessment will be performed in the fasting state including Endo-PAT2000, vital signs, waist circumference, fasting blood draw, \& urine sample. This will be considered Day 1 of the study for this group of patients. Time 2 (2-5 hours from Time 1): Two to five hours after Time 1, patients will undergo assessment of blood pressure \& heart rate, including orthostatics \& Endo-PAT2000 testing. Time 5 -- End of Study visit (14-34 weeks from Time 1): At a time point 14 to 34 weeks later than Time 1 patients will undergo study testing in the fasting state. This includes Endo-PAT2000 testing, vital signs including orthostatics, waist circumference, fasting blood draw, \& urine sample. The Surgery-Only Group will not have any assessment at Time 3 (Day 2) or Time 4 (Day 5) due to logistical concerns. Long-Term Follow Up Assessment Time 6 (24-30 months following Time 1)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
MALE
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Darren Feldman, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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11-140
Identifier Type: -
Identifier Source: org_study_id