Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:14 AM
Ignite Modification Date:
2025-12-25 @ 2:14 AM
NCT ID:
NCT01453660
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.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT01453660
Study Brief:
Protocol Section:
NCT01453660