Anal Cancer Clinical Trial
Official title:
Infrared Coagulator For Treatment Of High Grade Squamous Intraepithelial Neoplasia (HSIL) in the Anal Canal In HIV Infected Individuals: A Pilot Study
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.
OBJECTIVES:
- Determine the recurrence rate of high-grade squamous intraepithelial neoplasia in the
anal canal of HIV-positive patients treated with infrared coagulation.
- Determine the time to recurrence and time to progression in patients treated with this
procedure.
- Determine the toxicity of this procedure in these patients.
- Correlate CD4/CD8 count and HIV viral load with outcome in patients treated with this
procedure.
- Correlate outcome with human papilloma virus subtype in patients treated with this
procedure.
OUTLINE: This is an open-label, pilot, multicenter study.
Patients undergo treatment with an infrared coagulator in direct contact with the lesion for
1.5 seconds and necrotic tissue is then debrided. Treatment repeats to the level of the
submucosal vessels under colposcopic guidance. A repeat biopsy is performed at 3 months to
assess treatment success. Patients with incompletely treated lesions receive 1 more
treatment. Up to 3 lesions are treated during each visit in the absence of disease
progression or unacceptable toxicity.
Patients complete questionnaires regarding anal pain and discomfort at baseline, at 4 weeks,
and at 3, 6, 9, and 12 months.
Patients are followed every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study within 6 months.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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