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.
Documentation of receipt of ART by a licensed health care provider (Documentation may be a record of an ART prescription in the participant's medical record, a written prescription in the name of the participant for ART, or pill bottles for ART with a label showing the participant's name. Antiretroviral drug regimens used for pre-exposure prophylaxis (PrEP) may not satisfy this requirement.;
HIV-1 RNA detection by a licensed HIV-1 RNA assay demonstrating >1000 RNA copies/mL confirmed by a licensed screening antibody and/or HIV antibody/antigen combination assay;
Any licensed HIV screening antibody and/or HIV antibody/antigen combination assay confirmed by a second licensed HIV assay such as a HIV-1 Western blot confirmation or HIV rapid multispot antibody differentiation assay.
None
Single group
Surgical
Procedure/SurgeryThe 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.
Satisfaction of 3 feasibility criteria across all participants and satisfaction of the feasibility criteria by at least 3 of 4 of the participating centers
* Slides from excised suspected OSSN lesions are successfully reviewed by central pathology and results of histopathology are communicated with the original site (i.e., meet all four criteria noted above) (Null hypothesis: p=0.5 vs. Alternative hypothesis: p≥0.8). * Participants undergoing suspected OSSN excision will not develop serious complications as defined in Section 4.4 (Observed complication rate of less than 20%). * Participants with biopsy-proven OSSN return for follow-up at 12 months (Null hypothesis: p=0.5 vs. Alternative hypothesis: p≥0.7).
Proportion of participants with suspected OSSN lesions who are found to have biopsy-proven OSSN.
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.
To estimate the proportion of biopsy-proven OSSN lesions excised with clear margins on histopathologic analysis.
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.
To characterize the nature and frequency of surgical complications in participants undergoing excision of suspected OSSN.
The chi-square test without continuity correction will be used to compare the sites. If a significant difference between sites is detected with respect to any of the feasibility endpoints. • Do not develop surgical complications.
To estimate 1-year recurrence rates of biopsy-proven OSSN following surgical excision.
We will use the HybriSpot HPV Direct Flow Chip kit (Master Diagnóstica) to detect HPV DNA in formalin-fixed paraffin-embedded (FFPE) tissue samples.
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AIDS Malignancy Consortium
Lead sponsor
National Cancer Institute (NCI)
Collaborator
