Clinical trial NCT01453660: Acute Changes in Endothelial Function in Germ Cell Tumor Patients Treated With Cisplatin and Untreated Germ Cell Tumor Controls
Official title: A Pilot Study Measuring Acute Changes in Endothelial Function in Germ Cell Tumor Patients Treated With Cisplatin and Untreated Germ Cell Tumor Controls
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Germ Cell Cancer
Keywords: Endothelial Function
Endo-PAT2000 system
11-140
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2011-10-18
Enrollment: 44
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Measure the endothelial reactivity (PAT-RH) in both groups
timeFrame: 15 minutes
Secondary outcomes:
measure: Identify sociodemographic
timeFrame: 2 years
measure: Identify comorbid health conditions
timeFrame: 2 years
measure: Measure PAT-RH index
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Darren Feldman, MD
role: PRINCIPAL_INVESTIGATOR
References: