About this trial
The study involves enrollment of patients with sebaceous carcinoma, Merkel's carcinoma, Porocarcinoma, Melanoma, and squamous cell Ca of the ocular surface and adnexa both primary and relapsed after surgical and/or radiation-chemotherapy treatment at the Fondazione Policlinico Universitario A. Gemelli, IRCCS. The study will last 9 years: 1 year will be devoted to the first phase of the study. Patient enrollment will continue for an additional 3 years, and 5 years will be devoted overall to patient follow-up so that survival outcomes at 1-3 and 5 years can be assessed in a congruent number of patients. A preliminary analysis of the data at 1 year (pilot phase), an analysis at 4 years to confirm the preliminary study data on a larger sample, and a final analysis to evaluate OS and PFS at the 3 time-points indicated are planned.
Eligibility criteria
Qualifiers
All patients with Porocarcinoma, Ca of Merkel, Ca Sebaceous
Patients with cutaneous adnexal melanoma with thickness ≥1.5 mm, Clark's level ≥3, >1 mitotic figure per high-power field.
Patients with conjunctival melanoma both primary and recurrent and associated with primary acquired melanosis with atypia.
Patients with squamous cell Ca of adnexa with Staging ≥3, locally recurrent or with perineural invasion
Disqualifiers
Age less than 18 years
Patients with metastatic disease at diagnosis
All patients who do not fit the inclusion criteria
Failure to obtain informed consent
Trial design
Treatments tested in this trial
- Sentinel Lymph Node Biopsy