Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers
Recruiting · NCT05797415 · Observational (researchers observe without assigning treatment) · Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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
Where it is running
1 location listed.
- Gustavo Savino - Roma, Rome, Italy