Checking Lymph Nodes After Cancers Around the Eye
Studies a lymph node biopsy procedure in people with eye-area skin or surface cancers.
Plain-language title generated from the registry record
Registry title: Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers
Key facts
- Where
- Roma, ItalySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 95 years old?
Source: NCT05797415, who can take part
Where in Italy
- Gustavo SavinoRoma, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Trial code
- NCT05797415
- Record updated
- 1 October 2024
- Original description
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.Read full original descriptionShow less
Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers: Prospective Observational Study
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.
Inclusion: 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: Patients with metastatic disease at diagnosis; Failure to obtain informed consent; Age less than 18 years; All patients who do not fit the inclusion criteria.