Clinical trial Recruiting at 1 site Observational Ages 18 to 95

Evaluating Sentinel Lymph Node Biopsy for Ocular Surface and Eyelid Cancers

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

Run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · NCT05797415 · Data updated 2026-11-12

This study is testing if a specific biopsy method can help doctors find out if eye and eyelid cancers have spread in patients with these types of tumors.

More Merkel Cell Carcinoma trials

Quick facts

Study typeObservational
Ages18 Years to 95 Years
SexAll
Enrollment25 (estimated)
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
Academic / other
Drugs / interventionschemotherapy, radiation
Locations1 site (Roma, Rome)
StatusRecruiting
StartedMarch 1, 2023
Main results expectedMarch 1, 2025
Study endsMarch 15, 2032
Registry record updatedOctober 1, 2024
Trial IDNCT05797415 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults with specific types of ocular surface and adnexal cancers who meet the inclusion criteria.

Probably not a fit

Patients with metastatic disease at diagnosis or those under 18 years old will not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study focuses on patients diagnosed with various malignant ocular surface and adnexal tumors, including sebaceous carcinoma and Merkel cell carcinoma. Participants will undergo a series of evaluations, including staging, imaging, and sentinel lymph node biopsy, to assess the presence of cancer spread. The study spans nine years, with patient enrollment for three years and a five-year follow-up period to evaluate survival outcomes. Data will be analyzed at multiple time points to confirm findings and improve treatment strategies.

Why it matters

Potential benefit: If successful, this study could enhance the understanding of cancer spread in ocular tumors and improve treatment outcomes for affected patients.

How similar studies have gone: While similar approaches have been explored in other cancer types, this specific application in ocular tumors is relatively novel.

Who can join: the full rules

Show full 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

Where it's running

  • Gustavo Savino
    Roma, Rome, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.