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Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers

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About this study

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.

Condition
Ocular Sebaceous Carcinoma, Ocular Basal Cell Carcinoma, Ocular Surface Squamous Neoplasia, Merkel Cell Carcinoma, Unspecified, Porocarcinoma, Conjunctival Melanoma
Tested
Sentinel Lymph Node Biopsy
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Who can join

Age
18 to 95 years
Sex
All sexes
Healthy volunteers
Not stated

Inclusion 9

  • Minimum age: 18 years
  • Maximum age: 95 years
  • Study condition: Ocular Sebaceous Carcinoma, Ocular Basal Cell Carcinoma, Ocular Surface Squamous Neoplasia, Merkel Cell Carcinoma, Unspecified, Porocarcinoma, Conjunctival Melanoma
  • 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

Exclusion 4

  • 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

1 site, 1 recruiting

Gustavo Savino

Roma, Rome, Italy

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.