NCT04704648

Feasibility Study of Ocular Surface Squamous Neoplasia Surgical Excision in People Living With HIV in Sub-Saharan Africa

Feasibility Study of Ocular Surface Squamous Neoplasia (OSSN) Surgical Excision in People Living With HIV in Sub-Saharan Africa (SSA)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: AIDS Malignancy Consortium · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Participants will undergo surgical excision of OSSN at baseline and will be followed at 1 week, 6 weeks, 6 months, and 12 months for post-surgical follow up. This study is being conduced to assess the feasibility of conducting multi-center prospective studies on surgical excision of suspected OSSN lesions in SSA in people living with HIV/AIDS (PLWHA). Participants include those with HIV infection and with suspected non-invasive OSSN lesions that the AMC-certified ophthalmologist determines can be resected with 3 mm clinical margins, sparing involvement of the superior and inferior fornices and 6 clock hours of the corneal scleral limbus.

Detailed description

The AMC-certified ophthalmologist will obtain a thorough eye history and conduct a slit-lamp examination of both eyes. The AMC-certified ophthalmologist will draw the size and shape of the suspected lesion on a well-accepted template designed for documentation of ocular surface malignancies. Using this template, the AMC-certified ophthalmologist will document the number of clock hours of corneal-scleral limbus involved (6 clock hours maximum) as well as the maximum vertical and horizontal dimensions of the lesion in mm as determined through the use of the adjustable slit beam, whose length can be adjusted and determined using the slit length display window, a standard feature of slit lamp biomicroscopes. Eighty-four participants undergoing surgical excision of tumors suspicious for OSSN will be enrolled in this study. Participants who do not complete the study follow-up visits will not be replaced. The lesions will be swabbed prior to surgical excision and the swabs will be placed in PrimeStore MTM solution, for HPV DNA testing. The suspected OSSN lesion will be excised with 3 mm margins as determined by clinical exam. The PrimeStore MTM solution will be sent to Stellenbosch University in Cape Town, South Africa for HPV testing. The surgically excised lesions will be fixed, aligned, embedded in paraffin, sectioned and evaluated by pathologists at each of the 4 study sites. Tissue will then be sent to Stellenbosch University in Cape Town, South Africa for confirmatory histopathologic analysis and HPV testing. To ensure reliable follow-up, we will collect detailed contact and alternate contact information from study participants. Participants will be asked to return for follow-up one week after surgery, 6 weeks after surgery, 6 months after surgery, and 12 months after surgery. At each of these follow-up visits, the AMC-certified ophthalmologist will obtain a thorough medical history and perform a slit-lamp examination of the eyes. At week 2, sites will contact participants via phone to review AEs. Participants will undergo a structured review of post-surgical signs and symptoms at each follow-up visit. Participants presenting with a suspected recurrent OSSN lesion at follow-up will undergo re-excision per routine clinical care, including any follow-up per the local standard of care. After local diagnostic review, excised specimens will be sent for central histopathology evaluation and confirmation of recurrent OSSN or not recurrent OSSN. All other ocular lesions and conditions will be referred for routine medical care, outside of the study.

Conditions

• Ocular Surface Squamous Neoplasia
• HPV

Interventions

Type	Name	Description
PROCEDURE	Surgical	The treatment involves excision only of the conjunctival lesion with 3 mm margins. Surgeons (registered as investigators at each site) will perform the operation in accordance with the procedures outlined in the AMC-104 manual of procedures (MOP). As part of the study patients will be asked to return for follow-up evaluation 1 week, 6 weeks, 6 months, and 12 months after surgery. At each of these follow-up visits, the AMC-certified ophthalmologist will obtain a thorough ocular history as well as a history of AIDS-defining illnesses and perform a slit-lamp examination of both eyes, complete with templated drawings of the conjunctiva, and careful examination of the cornea for limbal stem cell deficiency.

Timeline

• Start date: 2023-06-21
• Primary completion: 2027-12-30
• Completion: 2027-12-30
• First posted: 2021-01-12
• Last updated: 2026-03-23

Locations

1 site across 1 country: Uganda