BLS: Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)

Overall Status

Recruiting

CT.gov ID

NCT05797415

Collaborator

(none)

Enrollment

Location

108.5

Anticipated Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ocular Sebaceous Carcinoma Ocular Basal Cell Carcinoma Ocular Surface Squamous Neoplasia Merkel Cell Carcinoma, Unspecified Porocarcinoma Conjunctival Melanoma	Procedure: Sentinel Lymph Node Biopsy

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

25 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2025

Anticipated Study Completion Date :

Mar 15, 2032

Arms and Interventions

Arm	Intervention/Treatment
Sebaceous carcinoma 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 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.
Merkel's carcinoma 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 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.
Porocarcinoma 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 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.
Conjunctival Melanoma 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 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.
Squamous cell Carcinoma 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 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.

Outcome Measures

Primary Outcome Measures

Efficacy of lymphoscintigraphic examination and SLN biopsy [9 years]
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.
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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 95 Years

Sexes Eligible for Study:

All

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