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:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-24 @ 7:59 PM
NCT ID:
NCT01500304
Eligibility Criteria:
Inclusion criteria:
* Malignant melanoma present in an inguinal nodal basin requiring superficial inguinal lymph node dissection.
* Plan for superficial inguinal dissection alone or combined superficial inguinal and deep pelvic node dissection is acceptable.
* Clinical or radiographic evidence of superficial inguinal lymph node disease or a prior positive single lymph node biopsy of the superficial inguinal basin as an indication for superficial inguinal lymph node disease is acceptable.
* Patients must be Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 and be healthy enough to undergo a general anesthetic (no epidural or spinal anesthetics).
* Female patients of child bearing age must have a negative pregnancy test, be surgically sterile or post-menopausal greater than 1 year.
* Patients must be able to return to surgical facility for 30 and/or 90 day (+/- 20 days) for follow-up appointment.
Exclusion Criteria:
* Prior ipsilateral superficial inguinal lymph node dissection
* Invasion or ulceration of inguinal nodal disease into the overlying skin
* Prior radiation therapy to the same regional nodal basin.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01500304
Study Brief:
Protocol Section:
NCT01500304