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 @ 2:39 AM
Ignite Modification Date:
2025-12-25 @ 2:39 AM
NCT ID:
NCT01259934
Eligibility Criteria:
Inclusion Criteria:
* T4 N0 M0 - Thick primary melanoma: \> 4.0 mm Breslow depth, without lymph node involvement, or
* Tx N1-2 M0 Primary melanoma of any thickness with regional lymph node metastases confirmed by lymphadenectomy, or
* Tx N1-2 M0 Recurrent melanoma in regional lymph node(s) confirmed by lymphadenectomy.
* ECOG performance status of 0-1
* No active medical or psychiatric disorder requiring therapy that would prevent completion of protocol
* Written informed consent
Exclusion Criteria:
* Patients with unknown primary site of melanoma or primary melanoma originating apart from the skin, except subungual melanoma
* Patients who have clinical, radiological/laboratory or pathological evidence of incompletely resected melanoma or distant metastatic disease
* Patients who have had prior adjuvant radiotherapy, chemotherapy, immunotherapy including preoperative infusion or perfusion therapy
* Female patients who are pregnant or lactating
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01259934
Study Brief:
Protocol Section:
NCT01259934