Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers (BLS)

April 3, 2023 updated by: Savino Gustavo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of lymphoscintigraphic examination and SLN biopsy
Time Frame: 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.
9 years
Efficacy of lymphoscintigraphic examination and SLN biopsy
Time Frame: 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.
9 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

March 15, 2032

Study Registration Dates

First Submitted

March 6, 2023

First Submitted That Met QC Criteria

April 3, 2023

First Posted (Actual)

April 4, 2023

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

April 3, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5572

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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