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Clinical Trials in Italy / NCT05797415
Recruiting Observational

Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers

NCT05797415 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase
Observational
Started
2023-03-01
Last updated
2024-10-01

Condition(s) studied

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

Investigational drug(s) / intervention(s)

Sentinel Lymph Node Biopsy

Sentinel 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
95 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Efficacy of lymphoscintigraphic examination and SLN biopsy — 9 years
    Positive predictive value (PPV) and negative predictive value (NPV), in percentage, in order to determine the likelihood of lymphoscintigraphic examination and SLN biopsy in diagnosing Ocular Surface and Adnexal Cancers.
  • Efficacy of lymphoscintigraphic examination and SLN biopsy — 9 years
    Sensitivity and sensibility, in percentage, in order to determine the likelihood of lymphoscintigraphic examination and SLN biopsy in diagnosing Ocular Surface and Adnexal Cancers.

Trial sites (1)

FacilityCityRegionStatus
Gustavo Savino Roma Rome Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05797415 on ClinicalTrials.gov ↗ ← All trials in Italy