Evaluating Sentinel Lymph Node Biopsy for Ocular Surface and Eyelid Cancers
Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers: Prospective Observational Study
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 |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 95 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Roma, Rome) |
| Trial ID | NCT05797415 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults with specific types of ocular surface and adnexal cancers who meet the inclusion criteria.
Not a fit: Patients with metastatic disease at diagnosis or those under 18 years old will not benefit from this study.
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 performed: While similar approaches have been explored in other cancer types, this specific application in ocular tumors is relatively novel.
Eligibility criteria
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 this trial is running
Roma, Rome
- Gustavo Savino — Roma, Rome, Italy (Recruiting)
Study contacts
- Study coordinator: Gustavo Savino, MD
- Email: oncologiaoculare@policlinicogemelli.it
- Phone: 0630154528
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.