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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 95
View:

• 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

Locations
Other Locations
Italy
Gustavo Savino
RECRUITING
Roma
Contact Information
Primary
Gustavo Savino, MD
oncologiaoculare@policlinicogemelli.it
0630154528
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2032-03-15
Participants
Target number of participants: 25
Treatments
Sebaceous carcinoma
patients with sebaceous carcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS
Merkel's carcinoma
patients with Merkel's carcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS
Porocarcinoma
patients with Porocarcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS
Conjunctival Melanoma
patients with Conjunctival Melanoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS
Squamous cell Carcinoma
patients with squamous cell Carcinoma of the ocular surface and adnexa both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS
Sponsors
Leads: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

This content was sourced from clinicaltrials.gov