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Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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.
Official title: Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers: Prospective Observational Study
Key Details
Gender
All
Age Range
18 Years - 95 Years
Study Type
OBSERVATIONAL
Enrollment
25
Start Date
2023-03-01
Completion Date
2032-03-15
Last Updated
2024-10-01
Healthy Volunteers
Not specified
Conditions
Interventions
Sentinel 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