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:
2025-12-26 @ 10:16 PM
Ignite Modification Date:
2025-12-26 @ 10:16 PM
NCT ID:
NCT01500512
Eligibility Criteria:
Inclusion Criteria:
* Patients must have squamous cell carcinoma with a depth invasion \> 1 mm
* Patients must have T1 or T2 tumors (International Federation of Gynecology and Obstetrics\[FIGO\] staging), \< 4 cm, not encroaching in urethra, vagina, or anus with clinically negative inguinofemoral lymph nodes
* Localization and size of the tumor are such that peri-lesional injection of the tracers at three or four sites is possible
* Preoperative imaging do not show enlarged (\< 1.5 cm) suspicious nodes
* Patients must sign informed consent
Exclusion Criteria:
* Inoperable tumors with diameter \> 4 cm
* Patients with inguinofemoral lymph nodes, at palpation clinically suspect for metastases, at radiology enlarged (\> 1.5 cm) suspicious groin nodes and with cytologically proven inguinofemoral lymph node metastases
* Patients with multifocal tumors
* Patients who are currently on an investigational drug for the treatment of vulvar cancer are excluded from participation in this trial
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT01500512
Study Brief:
Protocol Section:
NCT01500512