Clinical trial NCT05797415: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ocular Sebaceous Carcinoma
Ocular Basal Cell Carcinoma
Ocular Surface Squamous Neoplasia
Merkel Cell Carcinoma, Unspecified
Porocarcinoma
Conjunctival Melanoma
Keywords: Sentinel Lymph Node Biopsy
Malignant ocular surface tumors
Malignant eyelids tumors
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

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

Primary outcomes:
measure: Efficacy of lymphoscintigraphic examination and SLN biopsy
timeFrame: 9 years
measure: Efficacy of lymphoscintigraphic examination and SLN biopsy
timeFrame: 9 years
Secondary outcomes:
measure: Overall survival (OS)
timeFrame: 5 years
measure: Diseases Free Survival (DFS)
timeFrame: 5 years
measure: Progression Free Survival (PFS)
timeFrame: 5 years
measure: Changes in clinical parameter (tumor diameters)
timeFrame: 60 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Gustavo Savino
state: Rome
Study officials:
References:
citation: 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.
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citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.