RecruitingNot Applicable

Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers

Italy25 participantsStarted 2023-03-01

Plain-language summary

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.

Who can participate

Age range18 Years – 95 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 * Patients with squamous cell Ca of the surface with Staging ≥3 and/or multicenter * Signature of informed consent to participate in the study * cNo Exclusion Criteria: * 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

What they're measuring

Efficacy of lymphoscintigraphic examination and SLN biopsy

Timeframe: 9 years

Efficacy of lymphoscintigraphic examination and SLN biopsy

Timeframe: 9 years

Trial details

NCT IDNCT05797415

SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-03-01

Contact for this trial

Gustavo Savino, MD

0630154528 oncologiaoculare@policlinicogemelli.it