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Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Observational
Eligible Ages 18 Years - 95 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT05797415
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries Italy
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Ocular Sebaceous Carcinoma, Ocular Basal Cell Carcinoma, Ocular Surface Squamous Neoplasia, Merkel Cell Carcinoma, Unspecified, Porocarcinoma, Conjunctival Melanoma
Additional Details

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.

Arms & Interventions

Arms

: Sebaceous carcinoma

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

: 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

: Porocarcinoma

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

: Conjunctival Melanoma

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

: 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

Interventions

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Gustavo Savino, Roma, Rome, Italy

Status

Recruiting

Address

Gustavo Savino

Roma, Rome, 00168

Site Contact

Gustavo Savino, MD

[email protected]

+390630154528

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