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.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 95 Years |
| Sex | All |
| Enrollment | 25 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Roma, Rome) |
| Status | Recruiting |
| Started | March 1, 2023 |
| Main results expected | March 1, 2025 |
| Study ends | March 15, 2032 |
| Registry record updated | October 1, 2024 |
| Trial ID | NCT05797415 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
- Study coordinator: Gustavo Savino, MD
- Email: oncologiaoculare@policlinicogemelli.it
- Phone: 0630154528
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.