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.
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
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
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 Fondazione Policlinico Universitario A.Gemelli IRCCS will be enrolled in the study.
Cohort
Prospective
Sentinel Lymph Node Biopsy
Procedure/Surgery* Injection of 99mTc-labeled nanocolloids * Preoperative lymphoscintigraphy * Intraoperative gamma probe search of the sentinel lymph node * Sentinel lymph node biopsy * Excisional biopsy of the neoformation in cases not undergoing excision before SLN biopsy. * If the SLN is histologically positive, the multidisciplinary team will consider whether to refer the patient for parotidectomy and excision of the lymph node chain and/or adjuvant radio/chemotherapy.
Efficacy of lymphoscintigraphic examination and SLN biopsy
Positive predictive value (PPV) and negative predictive value (NPV), in percentage, in order to determine the likelihood of lymphoscintigraphic examination and SLN biopsy in diagnosing Ocular Surface and Adnexal Cancers.
Efficacy of lymphoscintigraphic examination and SLN biopsy
Sensitivity and sensibility, in percentage, in order to determine the likelihood of lymphoscintigraphic examination and SLN biopsy in diagnosing Ocular Surface and Adnexal Cancers.
Overall survival (OS)
OS (in years) at 1, 3, and 5 years
Diseases Free Survival (DFS)
DFS (in years) at 1,3 and 5 years
Progression Free Survival (PFS)
PFS (in years) at 1, 3, and 5 years
Changes in clinical parameter (tumor diameters)
Changes in clinical parameter (tumor diameters) of patients at follow-up (3, 6, 12, 24, 36, 48, 60 months)
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