Ocular Surface Squamous NeoplasiaNCT04704648
Feasibility Study of Ocular Surface Squamous Neoplasia Surgical Excision in People Living With HIV in Sub-Saharan Africa
A study testing Surgical in people with Ocular Surface Squamous Neoplasia and HPV, run by AIDS Malignancy Consortium at 1 site in Uganda.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ocular Surface Squamous Neoplasia, HPV
- What is being tested?
- Surgical
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUganda
- Study dates
- 21 Jun 2023to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 3.2.1 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.
- 3.2.2 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.
- 3.2.3 Performance status ≤ 2 on the WHO Scale (see Appendix III).
Who cannot join
- 3.3.1 Participants who are receiving any other investigational agents within 30 days before enrollment for surgery, except for investigational ART regimens, which will be permitted.
- 3.3.2 Participants with known history of ocular surface lesions including OSSN, other ocular neoplasm, pterygia, or limbal vernal keratoconjunctivitis.
- 3.3.3 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Uganda1 site, 1 recruiting
- Recruiting
Uganda Cancer Institute
Kampala
Anne Ampaire Musika, MMed, MSC, 256772424995, annemusika@gmail.com
Anne Ampaire Musika, MMed, MSC
About this study
Official title: Feasibility Study of Ocular Surface Squamous Neoplasia (OSSN) Surgical Excision in People Living With HIV in Sub-Saharan Africa (SSA)
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.
Read the 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
- Being tested
- Surgical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgicalProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Surgical |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Secondary outcomes (5)
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
To determine whether HPV is present in biopsy-proven OSSN pathology specimens.
We will use the HybriSpot HPV Direct Flow Chip kit (Master Diagnóstica) to detect HPV DNA in formalin-fixed paraffin-embedded (FFPE) tissue samples.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start21 Jun 2023
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular Surface Squamous NeoplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AIDS Malignancy Consortium
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04704648
- Sponsor's protocol ID
- AMC-104
- Other IDs
- UM1CA121947
- Status last verified
- Mar 2026
- First submitted
- 30 Nov 2020
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Ocular Surface Squamous Neoplasia (OSSN) Surgical Excision in People Living With HIV in Sub-Saharan Africa (SSA)
- ClinicalTrials.gov ID
- NCT04704648
- Acronym / sponsor ID
- AMC-104
- Conditions
- Ocular Surface Squamous Neoplasia, HPV
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- AIDS Malignancy ConsortiumResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 12 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Surgical Excision | Other | Procedure: SurgicalTreatment 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 3.2.1 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.
- 3.2.2 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.
Key exclusion criteria (3 listed)
- 3.3.1 Participants who are receiving any other investigational agents within 30 days before enrollment for surgery, except for investigational ART regimens, which will be permitted.
- 3.3.2 Participants with known history of ocular surface lesions including OSSN, other ocular neoplasm, pterygia, or limbal vernal keratoconjunctivitis.
- 3.3.3 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgicalThe 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. | Procedure or surgery | Surgical Excision |
Primary outcome
Satisfaction of 3 feasibility criteria across all participants and satisfaction of the feasibility criteria by at least 3 of 4 of the participating centers
Time frame: 12 months
* 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).
5 secondary outcomes
Proportion of participants with suspected OSSN lesions who are found to have biopsy-proven OSSN.
Time frame: 12 months
To estimate the proportion of biopsy-proven OSSN lesions excised with clear margins on histopathologic analysis.
Time frame: 12 months
To characterize the nature and frequency of surgical complications in participants undergoing excision of suspected OSSN.
Time frame: 12 months
To estimate 1-year recurrence rates of biopsy-proven OSSN following surgical excision.
Time frame: 12 months
To determine whether HPV is present in biopsy-proven OSSN pathology specimens.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical in people with Ocular Surface Squamous Neoplasia and HPV, run by AIDS Malignancy Consortium at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Satisfaction of 3 feasibility criteria across all participants and satisfaction of the feasibility criteria by at least 3 of 4 of the participating centers (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.