Infrared Coagulation in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia (NCT00066430) | Clinical Trial Compass
CompletedPhase 1
Infrared Coagulation in Preventing Anal Cancer in Patients With HIV Who Have Anal Neoplasia
United States18 participantsStarted 2003-09
Plain-language summary
RATIONALE: Infrared coagulation may be effective in preventing the development of anal cancer in patients who have anal neoplasia.
PURPOSE: Pilot study to evaluate the effectiveness of infrared coagulation in preventing anal cancer in HIV-positive patients who have high-grade anal neoplasia.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
DISEASE CHARACTERISTICS:
* HIV positive
* Presence of internal anal lesions with histologically confirmed high-grade squamous intraepithelial neoplasia with at least 1 positive margin
* No more than 3 lesions, each no more than 10 mm in diameter
* No evidence of microscopic invasion in any anal biopsy specimens
* No history of anal cancer
PATIENT CHARACTERISTICS:
Age
* Over 18
Performance status
* Karnofsky 70-100%
Life expectancy
* Not specified
Hematopoietic
* Platelet count at least 50,000/mm\^3
* CD4 count at least 50 cells/mm\^3
Hepatic
* Not specified
Renal
* Not specified
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No allergy to lidocaine
* No anal insertions, including enemas or anal intercourse, for 24 hours before and at least 1 week after study treatment
* No prior severe photosensitivity reaction
* No active opportunistic infection
* No concurrent neoplasia requiring cytotoxic therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* Not specified
Radiotherapy
* Not specified
Surgery
* Not specified
Other
* Must be on stable regimen of highly active antiretroviral therapy (HAART) for at least 12 weeks prior to study entry unless CD4 count \> 200/mm\^3 AND no plans to initiate HAART within the next 3 months
* More than 14 days since prior acute treatment for an infection or other medical illness
* No prior inf…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used infrared coagulation to treat precancerous anal tissue in HIV-positive patients — since it was a Phase 1 study focused mainly on safety, what do we actually know at this point about whether the treatment is effective at preventing anal cancer long-term?
2Because this trial was specifically designed for HIV-positive patients with anal neoplasia, how does my own HIV status and immune function affect whether this kind of treatment approach would even be appropriate for me?
3Since this trial has already completed, has the data from it been published, and does it change what you would recommend as a standard treatment for my anal precancerous condition today?
4Infrared coagulation is a procedure — what would recovery look like, and are there risks specific to people with HIV or compromised immune systems that I should weigh against other options?
5Given that this was a Phase 1 trial focused on early safety testing, are there more advanced or more recent studies building on this work that might be worth discussing as an alternative path forward?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.