Anal Injury Screening for High Risk HPV in Population With Susceptibility to Anal Cancer Development
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Percentage of positive results for Anal Test system versus anal liquid cytology and anoscopy for the presence of high-risk human papillomaviruses
研究概览
简要总结
The diagnosis of anal cancer is superior with the Anal Test system compared to liquid cytology and anoscopy.
详细描述
DESIGN METHODOLOGY: Prospective, cross-sectional, comparative, double-blind, randomized.
STUDY POPULATION:
Group 1, 250 HIV negative patients (150 men and 100 women) from the oncology service who agree to participate in the study and with a negative diagnosis for HIV made at the Infectious Diseases Service.
Group 2, 250 HIV positive patients (150 men and 100 women) attended by the Infectious Disease Service diagnosed with HIV positive. The sample size was adjusted to the donation of 500 Anal Test devices and the subsequent molecular determinations for each sample.
PROCEDURE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women between 30 and 65 years old.
- •They agree to participate in the study and sign informed consent.
- •They have not received previous treatments for HPV or had previous intraepithelial lesions or anal cancer.
- •Immunosuppressed patients.
- •Women with LIAG of the genital tract (cervix, vagina, or vulva).
- •Patients who have had anal intercourse
排除标准
- •Patients sexually inactive
- •Subjects who had anal sex in less than 24 hours prior to the study.
- •Patients with local medication application (enemas, suppositories).
结局指标
主要结局
Percentage of positive results for Anal Test system versus anal liquid cytology and anoscopy for the presence of high-risk human papillomaviruses
时间窗: 12 months
Statistical difference for percentages of the presence of high-risk human papillomaviruses between self-test versus liquid anal cytology.
次要结局
- Number and percentage of LSIL and HSIL for patients using self-test (by presence of mRNA for viral proteins E6 and E7) compared to number and percentage of LSIL and HSIL for patients with liquid cytology or with results by biopsy.(12 months)
- Number and percentage of patients to have a positive opinion to use Self-Test system.(12 months)
- Number of predictive value for positive and negative results for self-test versus liquid cytology results(12 months)
- Number and percentage of patients with anal intraepithelial lesions caused by HPV-Ar infection compared between HIV-positive and HIV-negative patients(12 months)
研究者
Dr. Carlos E. Aranda Flores
Surgeon, specialty in oncology
Hospital General de México Dr. Eduardo Liceaga