Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04704648

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

Led by AIDS Malignancy Consortium · Updated on 2026-03-23

84

Participants Needed

1

Research Sites

236 weeks

Total Duration

On this page

Sponsors

A

AIDS Malignancy Consortium

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Suspected unilateral, non-invasive OSSN lesion that can be surgically removed with 3 mm clinical margins, sparing the superior and inferior fornices and up to 6 clock hours of the corneal scleral limbus
  • Confirmed HIV-1 infection documented by ART prescription, HIV RNA assay, or licensed antibody/antigen tests with confirmatory testing
  • Performance status of 2 or less on the WHO scale
Not Eligible

You will not qualify if you...

  • Receiving any other investigational agents within 30 days before surgery, except investigational ART regimens
  • History of ocular surface lesions including OSSN, other ocular tumors, pterygia, or limbal vernal keratoconjunctivitis
  • Uncontrolled illness or infection within 4 weeks before enrollment, or psychiatric/social issues limiting study compliance

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Uganda Cancer Institute

Kampala, Uganda

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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