Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Procedure: Sentinel Lymph Node Biopsy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sebaceous carcinoma<br>patients with sebaceous carcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS | Procedure: Sentinel Lymph Node Biopsy<br>* 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.<br>|
| Merkel's carcinoma<br>patients with Merkel's carcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS | Procedure: Sentinel Lymph Node Biopsy<br>* 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.<br>|
| Porocarcinoma<br>patients with Porocarcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS | Procedure: Sentinel Lymph Node Biopsy<br>* 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.<br>|
| Conjunctival Melanoma<br>patients with Conjunctival Melanoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS | Procedure: Sentinel Lymph Node Biopsy<br>* 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.<br>|
| Squamous cell Carcinoma<br>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 | Procedure: Sentinel Lymph Node Biopsy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of lymphoscintigraphic examination and SLN biopsy | 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. | 9 years | 
| Efficacy of lymphoscintigraphic examination and SLN biopsy | Sensitivity and sensibility, in percentage, in order to determine the likelihood of lymphoscintigraphic examination and SLN biopsy in diagnosing Ocular Surface and Adnexal Cancers. | 9 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sentinel Lymph Node Biopsy, Malignant ocular surface tumors, Malignant eyelids tumors