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


N/A
18 Years
N/A
Open (Enrolling)
Male
Germ Cell Cancer

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Trial Information

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


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

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

Outcome Description:

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).

Outcome Time Frame:

15 minutes

Safety Issue:

No

Principal Investigator

Darren Feldman, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

11-140

NCT ID:

NCT01453660

Start Date:

October 2011

Completion Date:

October 2014

Related Keywords:

  • Germ Cell Cancer
  • Endothelial Function
  • Endo-PAT2000 system
  • 11-140
  • Neoplasms, Germ Cell and Embryonal

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021