Can a plasma beam stop anal lesions from becoming cancer?
NCT ID NCT00428285
First seen Aug 14, 2026 · Last updated Aug 14, 2026
Summary
This phase II trial is testing whether argon plasma coagulation (APC) can safely and effectively treat high-grade anal lesions (AIN 2/3) in HIV-positive men who have sex with men. APC uses ionized argon gas to deliver a controlled electrical current that destroys abnormal cells. The study will enroll 20 participants and assess how well the procedure clears the lesions, as well as its tolerability and safety.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Argon plasma coagulation (APC), a procedure that uses ionized argon gas to destroy abnormal cells in the anal lining.
- What this could lead to
- If effective, APC could offer a safe, well-tolerated treatment option to prevent anal cancer in HIV-positive men with high-grade lesions.
- What could go wrong
- This is a small pilot study with only 20 participants, so results may not apply broadly. The procedure may cause discomfort or side effects, and its long-term effectiveness is not yet proven.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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20 people
The number who actually took part.
- Start date
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Feb 2007
- Finished
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Jul 2016
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age 18-65 years * The last two High Resolution Anoscopies (HRA) of the patient, occurring at least 4 months apart, revealed histologic diagnoses of AIN 2 or 3 * HIV infected for at least 6 months * Patient must be a man having sex with other men (currently or anteriorly). * Able to provide a signed and dated Research Ethics Board (REB)-approved informed consent form (ICF) for the study Exclusion Criteria: * History of invasive anal cancer * International normalized ratio (INR) \> 1.5 * Platelet count \< 50,000 * Previously (or currently) received chemotherapy or radiotherapy for AIN or anal cancer * Currently receiving interferon or cidofovir treatment * Diagnosed with circumferential (diffuse) high-grade AIN, or involving \> 75% of the anal canal.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Notre-Dame Hospital (Centre Hospitalier de l'Université de Montréal)
Montreal, Quebec, H2L 4M1, Canada
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Royal Victoria Hospital (McGill University Health Center)
Montreal, Quebec, H2X 2P4, Canada
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