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RecruitingNCT05797415

Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers

Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers: Prospective Observational Study

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

25 participants

Start Date

Mar 1, 2023

Study Type

OBSERVATIONAL

Conditions

Ocular Sebaceous CarcinomaOcular Basal Cell CarcinomaOcular Surface Squamous NeoplasiaMerkel Cell Carcinoma, UnspecifiedPorocarcinomaConjunctival Melanoma

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.

Eligibility

Min Age: 18 YearsMax Age: 95 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating the use of sentinel lymph node biopsy — a technique that identifies the first lymph node cancer might spread to — in patients with rare cancers of the eye area and surrounding tissues (ocular and adnexal cancers). **You may be eligible if...** - You have been diagnosed with a porocarcinoma, Merkel cell carcinoma, or sebaceous carcinoma of the eye area - OR you have cutaneous adnexal melanoma that is thicker than 1.5 mm, at a certain depth level, or with active cell division - OR you have conjunctival melanoma (melanoma on the surface of the eye), primary or recurring, including cases associated with pigment changes - OR you have squamous cell carcinoma of the adnexa at stage 3 or higher, that has recurred, or involves nerve invasion **You may NOT be eligible if...** - You do not have one of the listed cancer types - Other clinical criteria apply Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESentinel Lymph Node Biopsy

* 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.

Locations(1)

Gustavo Savino

Roma, Rome, Italy

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NCT05797415

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