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)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Professor

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Immune System Diseases

Acquired Immunodeficiency Syndrome

HIV Infections

Anti-Infective Agents

All Drugs and Chemicals

Anti-Bacterial Agents

Antibiotics, Antitubercular

Treatment involves EXCISION ONLY (surgery) for the conjunctival lesion with 3 mm margins. Surgeons (registered as investigators at each site) will perform the operation in accordance with the procedures outlined in the AMC-104 manual of procedures (MOP). Standard of care topical antibiotics are given for infection prevention following surgery. No drugs or device treatments are administered for treatment of OSSN in this protocol.

The treatment involves excision only of the conjunctival lesion with 3 mm margins. Surgeons (registered as investigators at each site) will perform the operation in accordance with the procedures outlined in the AMC-104 manual of procedures (MOP).

As part of the study patients will be asked to return for follow-up evaluation 1 week, 6 weeks, 6 months, and 12 months after surgery. At each of these follow-up visits, the AMC-certified ophthalmologist will obtain a thorough ocular history as well as a history of AIDS-defining illnesses and perform a slit-lamp examination of both eyes, complete with templated drawings of the conjunctiva, and careful examination of the cornea for limbal stem cell deficiency.

Surgical

Anne Ampaire Musika, MMed, MSC

Participants will undergo surgical excision of OSSN at baseline and will be followed at 1 week, 6 weeks, 6 months, and 12 months for post-surgical follow up. This study is being conduced to assess the feasibility of conducting multi-center prospective studies on surgical excision of suspected OSSN lesions in SSA in people living with HIV/AIDS (PLWHA). Participants include those with HIV infection and with suspected non-invasive OSSN lesions that the AMC-certified ophthalmologist determines can be resected with 3 mm clinical margins, sparing involvement of the superior and inferior fornices and 6 clock hours of the corneal scleral limbus.

The AMC-certified ophthalmologist will obtain a thorough eye history and conduct a slit-lamp examination of both eyes. The AMC-certified ophthalmologist will draw the size and shape of the suspected lesion on a well-accepted template designed for documentation of ocular surface malignancies. Using this template, the AMC-certified ophthalmologist will document the number of clock hours of corneal-scleral limbus involved (6 clock hours maximum) as well as the maximum vertical and horizontal dimensions of the lesion in mm as determined through the use of the adjustable slit beam, whose length can be adjusted and determined using the slit length display window, a standard feature of slit lamp biomicroscopes.

Eighty-four participants undergoing surgical excision of tumors suspicious for OSSN will be enrolled in this study. Participants who do not complete the study follow-up visits will not be replaced. The lesions will be swabbed prior to surgical excision and the swabs will be placed in PrimeStore MTM solution, for HPV DNA testing. The suspected OSSN lesion will be excised with 3 mm margins as determined by clinical exam. The PrimeStore MTM solution will be sent to Stellenbosch University in Cape Town, South Africa for HPV testing. The surgically excised lesions will be fixed, aligned, embedded in paraffin, sectioned and evaluated by pathologists at each of the 4 study sites. Tissue will then be sent to Stellenbosch University in Cape Town, South Africa for confirmatory histopathologic analysis and HPV testing.

To ensure reliable follow-up, we will collect detailed contact and alternate contact information from study participants. Participants will be asked to return for follow-up one week after surgery, 6 weeks after surgery, 6 months after surgery, and 12 months after surgery. At each of these follow-up visits, the AMC-certified ophthalmologist will obtain a thorough medical history and perform a slit-lamp examination of the eyes. At week 2, sites will contact participants via phone to review AEs. Participants will undergo a structured review of post-surgical signs and symptoms at each follow-up visit. Participants presenting with a suspected recurrent OSSN lesion at follow-up will undergo re-excision per routine clinical care, including any follow-up per the local standard of care. After local diagnostic review, excised specimens will be sent for central histopathology evaluation and confirmation of recurrent OSSN or not recurrent OSSN. All other ocular lesions and conditions will be referred for routine medical care, outside of the study.

Using an exact binomial one-sample test for proportions, 90% power and one-sided 0.0167 significance level (0.05/3 = 0.0167), the number of study participants required to test the hypotheses shown above, respectively, are 28, 28 and 68. Thus, this study will require 68 evaluable participants using a one-sample test of proportions. We define evaluable as participants with suspected OSSN lesions who are shown to have OSSN on biopsy. We estimate that 20% of participants will be found to have lesions that are histopathologically not OSSN and will therefore, not be evaluable. As a result, we are recruiting 84 individuals (21 per clinical site) to get 68 evaluable participants.

Feasibility Study of Ocular Surface Squamous Neoplasia Surgical Excision in People Living With HIV in Sub-Saharan Africa

Feasibility Study of Ocular Surface Squamous Neoplasia (OSSN) Surgical Excision in People Living With HIV in Sub-Saharan Africa (SSA)

* Slides from excised suspected OSSN lesions are successfully reviewed by central pathology and results of histopathology are communicated with the original site (i.e., meet all four criteria noted above) (Null hypothesis: p=0.5 vs. Alternative hypothesis: p≥0.8).
* Participants undergoing suspected OSSN excision will not develop serious complications as defined in Section 4.4 (Observed complication rate of less than 20%).
* Participants with biopsy-proven OSSN return for follow-up at 12 months (Null hypothesis: p=0.5 vs. Alternative hypothesis: p≥0.7).

Participants presenting with a suspected recurrent OSSN lesion at follow-up will undergo re-excision per routine clinical care, including any follow-up per the local standard of care. After local diagnostic review, excised specimens will be sent for central histopathology evaluation and confirmation of recurrent OSSN or not recurrent OSSN.

The chi-square test without continuity correction will be used to compare the sites. If a significant difference between sites is detected with respect to any of the feasibility endpoints.

• Do not develop surgical complications.

We will use the HybriSpot HPV Direct Flow Chip kit (Master Diagnóstica) to detect HPV DNA in formalin-fixed paraffin-embedded (FFPE) tissue samples.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
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
Feasibility Study of Ocular Surface Squamous Neoplasia Surgical Excision in People Living With HIV in Sub-Saharan Africa	NCT04704648	Ocular Surface ... HPV	Surgical	18 Years -	AIDS Malignancy Consortium

Spots Global Cancer Trial Database for ocular surface squamous neoplasia