Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Infections

Eye Diseases

Symptoms and General Pathology

Rare Diseases

Carcinoma

Melanoma

Carcinoma, Basal Cell

Carcinoma, Merkel Cell

Eyelid Neoplasms

Adenocarcinoma, Sebaceous

Eccrine Porocarcinoma

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Neoplasms, Basal Cell

Communicable Diseases

Polyomavirus Infections

Virus Diseases

DNA Virus Infections

Tumor Virus Infections

Carcinoma, Neuroendocrine

Neoplasms, Adnexal and Skin Appendage

Merkel Cell Carcinoma

Conjunctival Melanoma

Neuroendocrine Tumor

Neuroepithelioma

patients with sebaceous carcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS

patients with Merkel's carcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS

patients with Porocarcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS

patients with Conjunctival Melanoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS

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

* 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.

Sentinel Lymph Node Biopsy

Gustavo Savino, MD

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.

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.

Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers

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

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.

Sensitivity and sensibility, in percentage, in order to determine the likelihood of lymphoscintigraphic examination and SLN biopsy in diagnosing Ocular Surface and Adnexal Cancers.

Changes in clinical parameter (tumor diameters) of patients at follow-up (3, 6, 12, 24, 36, 48, 60 months)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers	NCT05797415	Ocular Sebaceou... Ocular Basal Ce... Ocular Surface ... Merkel Cell Car... Porocarcinoma Conjunctival Me...	Sentinel Lymph ...	18 Years - 95 Years	Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers	NCT05797415	Ocular Sebaceou... Ocular Basal Ce... Ocular Surface ... Merkel Cell Car... Porocarcinoma Conjunctival Me...	Sentinel Lymph ...	18 Years - 95 Years	Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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