Infrared Coagulator For Treatment Of High Grade Squamous Intraepithelial Neoplasia (HSIL) in the Anal Canal In HIV Infected Individuals: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 3
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •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
- •Not specified
- •Not specified
- •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
- •Not specified
- •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 infrared coagulation for anal dysplasia
排除标准
- 未提供