Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers

Recruiting

Conditions: Ocular Sebaceous Carcinoma
Merkel Cell Carcinoma, Unspecified
Ocular Basal Cell Carcinoma
Ocular Surface Squamous Neoplasia
Porocarcinoma
Conjunctival Melanoma

Brief 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.

Detailed Description: Patients will undergo:

* Evaluation in the ocular oncology outpatient clinic with examination and anterior segment photography

* Staging according to TNM AJCC 8th edition by incisional biopsy (if necessary after clinical evaluation) and/or excisional biopsy and imaging to be performed in current clinical practice (MRI with mdc orbits, massif and neck + Tc/Pet total body)

* Injection of 99mTc-labeled nanocolloids

* Preoperative lymphoscintigraphy

* Intraoperative search by gamma probe of the sentinel lymph node

* Sentinel lymph node biopsy

* Excisional biopsy of the neoformation in cases not undergoing excision before SLN biopsy.

* In case of SLN histologic positivity, the multidisciplinary team will consider whether to refer the patient for parotidectomy and excision of the lymph node chain and/or adjuvant radio/chemotherapy.

* Clinical-instrumental follow-up to be performed in current clinical practice (Clinical examination, cranial orbit and neck MRI, total body CT scan) at 3, 6, 12, 18, 24, 36, 48, 60 months or according to periodicity assessed on a case-by-case basis by the Tumor Board.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Conjunctival Melanoma	Sentinel Lymph Node Biopsy	patients with Conjunctival Melanoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS
Sebaceous carcinoma	Sentinel Lymph Node Biopsy	patients with sebaceous carcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS
Squamous cell Carcinoma	Sentinel Lymph Node Biopsy	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
Merkel's carcinoma	Sentinel Lymph Node Biopsy	patients with Merkel's carcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS
Porocarcinoma	Sentinel Lymph Node Biopsy	patients with Porocarcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Overall survival (OS)	5 years	OS (in years) at 1, 3, and 5 years
Diseases Free Survival (DFS)	5 years	DFS (in years) at 1,3 and 5 years
Progression Free Survival (PFS)	5 years	PFS (in years) at 1, 3, and 5 years
Changes in clinical parameter (tumor diameters)	60 months	Changes in clinical parameter (tumor diameters) of patients at follow-up (3, 6, 12, 24, 36, 48, 60 months)