Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers

Trial Title: Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers

NCT ID: NCT05797415

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

Conditions: Official terms:
Carcinoma, Merkel Cell
Carcinoma
Carcinoma, Basal Cell
Adenocarcinoma, Sebaceous

Conditions: Keywords:
Sentinel Lymph Node Biopsy
Malignant ocular surface tumors
Malignant eyelids tumors

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Procedure
Intervention name: Sentinel Lymph Node Biopsy
Description: - 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.
Arm group label: Conjunctival Melanoma
Arm group label: Merkel's carcinoma
Arm group label: Porocarcinoma
Arm group label: Sebaceous carcinoma
Arm group label: Squamous cell Carcinoma

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.

Criteria for eligibility:

Study pop:
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 Fondazione Policlinico Universitario A.Gemelli IRCCS will be enrolled in the study.

Sampling method: Probability Sample
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 95 Years

Locations:

Facility:
Name: Gustavo Savino

Address:
City: Roma
Zip: 00168
Country: Italy

Status: Recruiting

Contact:
Last name: Gustavo Savino, MD

Phone: +390630154528
Email: oncologiaoculare@policlinicogemelli.it

Start date: March 1, 2023

Completion date: March 15, 2032

Lead sponsor:
Agency: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Agency class: Other

Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05797415