Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers

Official title

Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers: Prospective Observational Study

Overview

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.

Detailed description

Patients will undergo:

* Evaluation in the ocular oncology outpatient clinic with examination and anterior segment photography * Staging according to TNM AJCC 8th edition by incisional biopsy (if necessary after clinical evaluation) and/or excisional biopsy and imaging to be performed in current clinical practice (MRI with mdc orbits, massif and neck + Tc/Pet total body) * Injection of 99mTc-labeled nanocolloids * Preoperative lymphoscintigraphy * Intraoperative search by gamma probe of the sentinel lymph node * Sentinel lymph node biopsy * Excisional biopsy of the neoformation in cases not undergoing excision before SLN biopsy. * In case of SLN histologic positivity, the multidisciplinary team will consider whether to refer the patient for parotidectomy and excision of the lymph node chain and/or adjuvant radio/chemotherapy. * Clinical-instrumental follow-up to be performed in current clinical practice (Clinical examination, cranial orbit and neck MRI, total body CT scan) at 3, 6, 12, 18, 24, 36, 48, 60 months or according to periodicity assessed on a case-by-case basis by the Tumor Board.

Interventions

• Procedure Sentinel Lymph Node Biopsy
  * Injection of 99mTc-labeled nanocolloids * Preoperative lymphoscintigraphy * Intraoperative gamma probe search of the sentinel lymph node * Sentinel lymph node biopsy * Excisional biopsy of the neoformation in cases not undergoing excision before SLN biopsy. * If the SLN is histologically positive, the multidisciplinary team will consider whether to refer the patient for parotidectomy and excision of the lymph node chain and/or adjuvant radio/chemotherapy.

Primary outcome measures

• Efficacy of lymphoscintigraphic examination and SLN biopsy [Time frame: 9 years]
• Efficacy of lymphoscintigraphic examination and SLN biopsy [Time frame: 9 years]

Secondary outcome measures (4)

• Overall survival (OS) [Time frame: 5 years]
• Diseases Free Survival (DFS) [Time frame: 5 years]
• Progression Free Survival (PFS) [Time frame: 5 years]
• Changes in clinical parameter (tumor diameters) [Time frame: 60 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model

Cohort

Study locations

Italy · 1 center

• Gustavo Savino — Roma

Publications

• 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. PMID 27725148
• 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. PMID 31755426
• 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. PMID 10923972
• 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. PMID 17020898
• 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. PMID 15465559
• 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. PMID 11865953
• 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. PMID 22189448
• 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. PMID 11766025

Identifiers

NCT: NCT05797415 · 5572

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗