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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Suspended to Recruiting
    • Site details revised
    v13
  2. Primary completion date: Oct 1, 2025 to Dec 30, 2027
    • Study completion date: Oct 1, 2026 to Dec 30, 2027
    v12
  3. Trial status: Recruiting to Suspended Sponsor's reason: Retraining on study procedures required
    • Study completion date: Oct 1, 2025 to Oct 1, 2026
    • Site details revised
    v11
  4. Collaborators: 5 to 1v10
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 28, 2023 to Jun 21, 2023
    v9
Show 7 earlier versionsHide 7 earlier versions
  1. Primary completion date: Jun 28, 2024 to Oct 1, 2025
    • Study completion date: Feb 28, 2025 to Oct 1, 2025
    v8
  2. Start date: Apr 28, 2023 to Jul 28, 2023v7
  3. Start date: Jan 28, 2023 to Apr 28, 2023v6
  4. Start date: Sep 28, 2022 to Jan 28, 2023v5
  5. Start date: Feb 28, 2022 to Sep 28, 2022v4
  6. Primary completion date: May 15, 2023 to Jun 28, 2024
    • Start date: Jan 15, 2022 to Feb 28, 2022
    • Study completion date: May 15, 2024 to Feb 28, 2025
    • Eligibility criteria shortened, about 1 word
    v3
  7. Primary completion date: Apr 15, 2022 to May 15, 2023
    • Start date: Apr 15, 2021 to Jan 15, 2022
    • Study completion date: Apr 16, 2022 to May 15, 2024
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04704648
Lead Sponsor AIDS Malignancy Consortium
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Ocular Surface Squamous Neoplasia, HPV
Enrollment 84 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov