Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Conjunctival Melanoma | Conjunctival Melanoma | ONTOLOGY_EXACT | 0.98 |
| Merkel Cell Carcinoma, Unspecified | Merkel Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Ocular Basal Cell Carcinoma | Eyelid Basal Cell Carcinoma | ALIAS | 0.90 |
| Ocular Sebaceous Carcinoma | Eye Sebaceous Carcinoma | ALIAS | 0.90 |
| Ocular Surface Squamous Neoplasia | Ocular Surface Squamous Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Porocarcinoma | Porocarcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sentinel Lymph Node Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- label
- Sebaceous carcinoma
- description
- patients with sebaceous carcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS
- interventionNames
- Procedure: Sentinel Lymph Node Biopsy
- label
- Merkel's carcinoma
- description
- patients with Merkel's carcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS
- interventionNames
- Procedure: Sentinel Lymph Node Biopsy
- label
- Porocarcinoma
- description
- patients with Porocarcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 95 Years
Show eligibility criteria text
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
References
Publications (13)
- BACKGROUNDShields CL, Alset AE, Boal NS, Casey MG, Knapp AN, Sugarman JA, Schoen MA, Gordon PS, Douglass AM, Sioufi K, Say EA, Shields JA. Conjunctival Tumors in 5002 Cases. Comparative Analysis of Benign Versus Malignant Counterparts. The 2016 James D. Allen Lecture. Am J Ophthalmol. 2017 Jan;173:106-133. doi: 10.1016/j.ajo.2016.09.034. Epub 2016 Oct 8. PMID 27725148
- BACKGROUNDShields CL, Shields JA. Tumors of the conjunctiva and cornea. Indian J Ophthalmol. 2019 Dec;67(12):1930-1948. doi: 10.4103/ijo.IJO_2040_19. PMID 31755426
- BACKGROUNDEsmaeli B, Wang B, Deavers M, Gillenwater A, Goepfert H, Diaz E, Eicher S. Prognostic factors for survival in malignant melanoma of the eyelid skin. Ophthalmic Plast Reconstr Surg. 2000 Jul;16(4):250-7. doi: 10.1097/00002341-200007000-00002. PMID 10923972
- BACKGROUNDSoysal HG, Markoc F. Invasive squamous cell carcinoma of the eyelids and periorbital region. Br J Ophthalmol. 2007 Mar;91(3):325-9. doi: 10.1136/bjo.2006.102673. Epub 2006 Oct 4. PMID 17020898
- BACKGROUNDFaustina M, Diba R, Ahmadi MA, Esmaeli B. Patterns of regional and distant metastasis in patients with eyelid and periocular squamous cell carcinoma. Ophthalmology. 2004 Oct;111(10):1930-2. doi: 10.1016/j.ophtha.2004.02.009. PMID 15465559
- BACKGROUNDCervantes G, Rodriguez AA Jr, Leal AG. Squamous cell carcinoma of the conjunctiva: clinicopathological features in 287 cases. Can J Ophthalmol. 2002 Feb;37(1):14-9; discussion 19-20. doi: 10.1016/s0008-4182(02)80093-x. PMID 11865953
- BACKGROUNDYousef YA, Finger PT. Squamous carcinoma and dysplasia of the conjunctiva and cornea: an analysis of 101 cases. Ophthalmology. 2012 Feb;119(2):233-40. doi: 10.1016/j.ophtha.2011.08.005. Epub 2011 Dec 20. PMID 22189448