Actively Recruiting
Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2024-10-01
25
Participants Needed
1
Research Sites
471 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with porocarcinoma, Merkel cell carcinoma, or sebaceous carcinoma
- Patients with cutaneous adnexal melanoma with thickness 651.5 mm, Clark's level 653, and more than 1 mitotic figure per high-power field
- Patients with primary or recurrent conjunctival melanoma associated with primary acquired melanosis with atypia
- Patients with squamous cell carcinoma of adnexa with staging 653, locally recurrent or with perineural invasion
- Patients with squamous cell carcinoma of the ocular surface with staging 653 and/or multicenter disease
- Signed informed consent to participate in the study
- No clinical evidence of lymph node metastasis (cNo)
You will not qualify if you...
- Age less than 18 years
- Patients with metastatic disease at diagnosis
- Patients who do not meet the inclusion criteria
- Failure to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Gustavo Savino
Roma, Rome, Italy, 00168
Actively Recruiting
Research Team
G
Gustavo Savino, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
5
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