Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers

Recruiting now

Conditions studied: Ocular Sebaceous Carcinoma, Ocular Basal Cell Carcinoma, Ocular Surface Squamous Neoplasia, Merkel Cell Carcinoma, Unspecified, Porocarcinoma, Conjunctival Melanoma

In brief

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.

Key facts

Study ID

NCT05797415

Run by

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

People needed

25

Starts

2023-03-01

Expected to finish

2032-03-15

Last updated by the study team

2024-10-01

Who can join

Age: 18 and older, up to 95. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Gustavo Savino — Roma, Rome, Italy (enrolling)

Full record on ClinicalTrials.gov

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