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

Active, not recruiting

• Conditions: Germ Cell Cancer
• Interventions: Other: Endo-PAT2000 testing

• Registration Number: NCT01453660
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10-11
• Study First Submitted: 2011-10-13
• Study First Submitted QC: 2011-10-13
• Study First Posted: 2011-10-18
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-08
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Male
• Target Recruitment: 44

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cisplatin-Based Chemotherapy Group	Endo-PAT2000 testing	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.
Surgery-Only Group	Endo-PAT2000 testing	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States