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

NCT04704648 | Recruiting

• 2 other identifiers: AMC-104UM1CA121947
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ocular Surface Squamous Neoplasia; HPV

Outcome Measures

Primary Outcomes (1)

• 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).

  12 months

Secondary Outcomes (5)

• Proportion of participants with suspected OSSN lesions who are found to have biopsy-proven OSSN.

  12 months

• To estimate the proportion of biopsy-proven OSSN lesions excised with clear margins on histopathologic analysis.

  12 months

• To characterize the nature and frequency of surgical complications in participants undergoing excision of suspected OSSN.

  12 months

• To estimate 1-year recurrence rates of biopsy-proven OSSN following surgical excision.

  12 months

• To determine whether HPV is present in biopsy-proven OSSN pathology specimens.

  12 months

Study Arms (1)

Surgical Excision

OTHER

Treatment involves EXCISION ONLY (surgery) for 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). Standard of care topical antibiotics are given for infection prevention following surgery. No drugs or device treatments are administered for treatment of OSSN in this protocol.

Procedure: Surgical

Interventions

Surgical PROCEDURE

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.

Surgical Excision

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants with suspected unilateral, 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 as well as 6 clock hours of the corneal scleral limbus. This assessment must be carried out within 4 weeks before surgery.
• HIV positive. Documentation of HIV-1 infection by means of any one of the following:
• 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.
• Note: The term "licensed" refers to a kit that has been certified or licensed by an oversight body within the participating country and validated internally (e.g., U.S. FDA).
• WHO and CDC (Centers for Disease Control and Prevention) guidelines mandate that confirmation of the initial test result must use a test that is different from the one used for the initial assessment. A reactive initial rapid test should be confirmed by either another type of rapid assay or an enzyme or chemiluminescence assay (E/CIA) that is based on a different antigen preparation and/or different test principle (e.g., indirect versus competitive), or a Western blot or a plasma HIV-1 RNA viral load.
• Performance status ≤ 2 on the WHO Scale (see Appendix III).

You may not qualify if:

• Participants who are receiving any other investigational agents within 30 days before enrollment for surgery, except for investigational ART regimens, which will be permitted.
• Participants with known history of ocular surface lesions including OSSN, other ocular neoplasm, pterygia, or limbal vernal keratoconjunctivitis.
• Uncontrolled intercurrent illness within 4 weeks before enrollment, including but not limited to ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.

Sponsors & Collaborators

• AIDS Malignancy Consortium: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Uganda Cancer Institute

Kampala, Uganda

RECRUITING

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Using an exact binomial one-sample test for proportions, 90% power and one-sided 0.0167 significance level (0.05/3 = 0.0167), the number of study participants required to test the hypotheses shown above, respectively, are 28, 28 and 68. Thus, this study will require 68 evaluable participants using a one-sample test of proportions. We define evaluable as participants with suspected OSSN lesions who are shown to have OSSN on biopsy. We estimate that 20% of participants will be found to have lesions that are histopathologically not OSSN and will therefore, not be evaluable. As a result, we are recruiting 84 individuals (21 per clinical site) to get 68 evaluable participants.

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: January 12, 2021
• Study Start: June 21, 2023
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)