Sentinel Lymph Node Biopsy in Ocular Surface and Adnexal Cancers

Porocarcinoma Clinical Trial

— BLS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05797415
• Other study ID #: 5572
• Status: Recruiting
• Start date: March 1, 2023
• Est. completion date: March 15, 2032

Study information

• Verified date: April 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: Gustavo Savino, MD
• Phone: 0630154528
• Email: oncologiaoculare[@]policlinicogemelli.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 15, 2032
• Est. primary completion date: March 1, 2025
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Basal Cell
• Carcinoma, Merkel Cell
• Ocular Surface Squamous Neoplasia
• Porocarcinoma

Intervention

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.

Locations

Country	Name	City	State
Italy	Gustavo Savino	Roma	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (13)

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. — View 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. — View 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. — View 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. — View Citation

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. — View Citation

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. Erratum In: Ophthalmology. 2005 Mar;112(3):446. Gutstein, Brett F [removed]. — View 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. — View 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. — View 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. — View 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. — View Citation

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. — View Citation

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. — View 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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	Overall survival (OS)	OS (in years) at 1, 3, and 5 years	5 years
Secondary	Diseases Free Survival (DFS)	DFS (in years) at 1,3 and 5 years	5 years
Secondary	Progression Free Survival (PFS)	PFS (in years) at 1, 3, and 5 years	5 years
Secondary	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