NCT05797415Recruiting
Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers
Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers: Prospective Observational Study
Source: ClinicalTrials.gov · Last updated 1 Oct 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 25 (estimated)
- First submitted
- 6 Mar 2023
- Start date
- 1 Mar 2023
- Primary completion date
- 1 Mar 2025
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Melanoma
- NCT number
- NCT05797415
What you commit to
- Study type: Observational
- Planned participants: 25
- From 1 Mar 2023 to the primary completion date, 1 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with metastatic disease at diagnosis
- Failure to obtain informed consent
Age
- Age less than 18 years
Other
- All patients who do not fit the inclusion criteria
Who the study is looking for
- 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
Age in the registry: 18 years to 95 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gustavo Savino Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.