Acute Changes in Endothelial Function in Germ Cell Tumor Patients Treated With Cisplatin and Untreated Germ Cell Tumor Controls

NCT01453660 | Active Not Recruiting

• 1 other identifier: 11-140
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Germ Cell Cancer

Keywords

Endothelial Function; Endo-PAT2000 system; 11-140

Outcome Measures

Primary Outcomes (1)

• Measure the endothelial reactivity (PAT-RH) in both groups

  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).

  15 minutes

Secondary Outcomes (3)

• Identify sociodemographic

  2 years

• Identify comorbid health conditions

  2 years

• Measure PAT-RH index

  2 years

Study Arms (2)

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.

Other: Endo-PAT2000 testing

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.

Other: Endo-PAT2000 testing

Interventions

Endo-PAT2000 testing OTHER

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)

Cisplatin-Based Chemotherapy Group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The Cisplatin-Based Chemotherapy Group will be recruited from the Genitourinary (GU) oncology clinics. The GU Oncology section has a large clinical service which ensures adequate recruitment. The Surgery-Only Group will consist of patients with a diagnosis of GCT who have recently had surgical management of their disease and are not planned to receive radiation or chemotherapy. Potentially eligible patients will be recruited from the GU Oncology and Urology clinics since they are seen by both services.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood, urine

MeSH Terms

Conditions

Neoplasms, Germ Cell and Embryonal

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms

Study Officials

• Darren Feldman, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: October 18, 2011
• Study Start: October 11, 2011
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Locations

US (1)