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RecruitingNCT05797415

Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers

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

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

25 participants

Start Date

Mar 1, 2023

Study Type

OBSERVATIONAL

Conditions

Ocular Sebaceous CarcinomaOcular Basal Cell CarcinomaOcular Surface Squamous NeoplasiaMerkel Cell Carcinoma, UnspecifiedPorocarcinomaConjunctival Melanoma

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

Min Age: 18 YearsMax Age: 95 Years

Inclusion Criteria8

  • 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
  • Failure to obtain informed consent

Exclusion Criteria2

  • Age less than 18 years
  • Patients with metastatic disease at diagnosis

Interventions

PROCEDURESentinel 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

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NCT05797415