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Active, Not Recruiting

NCT Number: NCT01453660

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Germ Cell Cancer Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Memorial Sloan Kettering Cancer Center

New York, 10065, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

Primary outcomes

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

    Time frame: 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 outcomes

  1. Identify sociodemographic

    Time frame: 2 years

    (age, race/ethnicity)

  2. Identify comorbid health conditions

    Time frame: 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

  3. Measure PAT-RH index

    Time frame: 2 years

    at Time 6 (Long-Term Follow Up Assessment) in the Cisplatin-Based Chemotherapy Group and evaluate long term changes in PATRH index.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

A Pilot Study Measuring Acute Changes in Endothelial Function in Germ Cell Tumor Patients Treated With Cisplatin and Untreated Germ Cell Tumor Controls

Important dates

Study start
2011
Primary completion
2026
Study completion
2026
First posted
Oct 18, 2011
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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