Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-95
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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

Treatment groups

25 Participants
are divided into 5 treatment groups