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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.
Patients will undergo:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sebaceous carcinoma | patients with sebaceous carcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS |
| |
| Merkel's carcinoma | patients with Merkel's carcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS |
| |
| Porocarcinoma | patients with Porocarcinoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS |
| |
| Conjunctival Melanoma | patients with Conjunctival Melanoma both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS |
| |
| Squamous cell Carcinoma | patients with squamous cell Carcinoma of the ocular surface and adnexa both primary and relapsed after surgical and/or radiation-chemotherapy treatment at Fondazione Policlinico Universitario A. Gemelli IRCCS |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sentinel Lymph Node Biopsy | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of lymphoscintigraphic examination and SLN biopsy | Positive predictive value (PPV) and negative predictive value (NPV), in percentage, in order to determine the likelihood of lymphoscintigraphic examination and SLN biopsy in diagnosing Ocular Surface and Adnexal Cancers. | 9 years |
| Efficacy of lymphoscintigraphic examination and SLN biopsy | Sensitivity and sensibility, in percentage, in order to determine the likelihood of lymphoscintigraphic examination and SLN biopsy in diagnosing Ocular Surface and Adnexal Cancers. | 9 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | OS (in years) at 1, 3, and 5 years | 5 years |
| Diseases Free Survival (DFS) | DFS (in years) at 1,3 and 5 years | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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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 Fondazione Policlinico Universitario A.Gemelli IRCCS will be enrolled in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gustavo Savino, MD | Contact | 0630154528 | oncologiaoculare@policlinicogemelli.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gustavo Savino | Recruiting | Roma | Rome | 00168 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27725148 | Background | Shields 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. | |
| 31755426 |
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|
|
| Progression Free Survival (PFS) | PFS (in years) at 1, 3, and 5 years | 5 years |
| Changes in clinical parameter (tumor diameters) | Changes in clinical parameter (tumor diameters) of patients at follow-up (3, 6, 12, 24, 36, 48, 60 months) | 60 months |
| Shields 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. |
| 10923972 | Background | Esmaeli 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. |
| 17020898 | Background | Soysal 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. |
| 15465559 | Background | Faustina 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. |
| 11865953 | Background | Cervantes 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. |
| 22189448 | Background | Yousef 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. |
| 11766025 | Background | Esmaeli B, Eicher S, Popp J, Delpassand E, Prieto VG, Gershenwald JE. Sentinel lymph node biopsy for conjunctival melanoma. Ophthalmic Plast Reconstr Surg. 2001 Nov;17(6):436-42. doi: 10.1097/00002341-200111000-00010. |
| 32698034 | Background | Freitag SK, Aakalu VK, Tao JP, Wladis EJ, Foster JA, Sobel RK, Yen MT. Sentinel Lymph Node Biopsy for Eyelid and Conjunctival Malignancy: A Report by the American Academy of Ophthalmology. Ophthalmology. 2020 Dec;127(12):1757-1765. doi: 10.1016/j.ophtha.2020.07.031. Epub 2020 Jul 19. |
| 23034693 | Background | Chak G, Morgan PV, Joseph JM, Tao JP. A positive sentinel lymph node in periocular invasive squamous cell carcinoma: a case series. Ophthalmic Plast Reconstr Surg. 2013 Jan-Feb;29(1):6-10. doi: 10.1097/IOP.0b013e31826a50f7. |
| 22262287 | Background | Maalouf TJ, Dolivet G, Angioi KS, Leroux A, Genin P, George JL. Sentinel lymph node biopsy in patients with conjunctival and eyelid cancers: experience in 17 patients. Ophthalmic Plast Reconstr Surg. 2012 Jan-Feb;28(1):30-4. doi: 10.1097/IOP.0b013e31822fb44b. |
| 34283293 | Background | Savino G, Cuffaro G, Maceroni M, Pagliara MM, Sammarco MG, Giraldi L, Blasi MA. Advanced ocular surface squamous cell carcinoma (OSSC): long-term follow-up. Graefes Arch Clin Exp Ophthalmol. 2021 Nov;259(11):3437-3443. doi: 10.1007/s00417-021-05264-3. Epub 2021 Jul 20. |
| 22330966 | Background | Esmaeli B, Nasser QJ, Cruz H, Fellman M, Warneke CL, Ivan D. American Joint Committee on Cancer T category for eyelid sebaceous carcinoma correlates with nodal metastasis and survival. Ophthalmology. 2012 May;119(5):1078-82. doi: 10.1016/j.ophtha.2011.11.006. Epub 2012 Feb 11. |
| ID | Term |
|---|---|
| D015266 | Carcinoma, Merkel Cell |
| D057090 | Eccrine Porocarcinoma |
| ID | Term |
|---|---|
| D027601 | Polyomavirus Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D018278 | Carcinoma, Neuroendocrine |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
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| ID | Term |
|---|---|
| D021701 | Sentinel Lymph Node Biopsy |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008197 | Lymph Node Excision |
| D008919 | Investigative Techniques |
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