Improving Screening Tools to Better Predict High-Grade Anal Dysplasia for MSM
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 415
- 试验地点
- 3
- 主要终点
- Accuracy of cytology specimens for Dacron swab compared to flocked nylon (NF) swab in predicting histology outcome
研究概览
简要总结
This clinical trial compares three anal cytology collection procedures (collected at a single visit) in men who have sex with men (MSM). It also compares two different tests for human papilloma virus, the virus that causes high grade anal dysplasia, which is thought to occur before anal cancer. This study may help doctors develop better screening for high-grade anal dysplasia in MSM in order to identify those who need to return for additional screening and treatment.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate the sensitivity & specificity, predictive positive value (PPV), & predictive negative value (PNV) (test characteristics) & cellularity, beta-globin, deoxyribonucleic acid (DNA), ribonucleic acid (RNA), & protein (quality measures) from nylon-flocked (NF)- & Dacron-swab protocols to detect biopsy-detected high-grade anal intraepithelial neoplasia (HG-AIN) & human papillomavirus (HPV)-infections, using randomized-controlled study design.
II. Evaluate the test characteristics for anal cancer screening algorithms that incorporate sequentially or simultaneously performed high-threshold molecular HPV tests, with & without cytology, to predict HG-AIN.
III. Evaluate the cost-effectiveness & relative cost of single- & multiple-test anal cancer screening algorithms.
OUTLINE:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Males who self-identify as having had or currently having sex with men; both human immunodeficiency virus (HIV)-infected and HIV-uninfected subjects are being enrolled
排除标准
- 未提供
研究组 & 干预措施
Screening (anal cytology collection)
Patients undergo anal cytology collection using 2 NF swabs and 1 Dacron swab for analysis via Pap staining, HPV genotyping, and PCR.
干预措施: Cytology Specimen Collection Procedure (Procedure)
Screening (anal cytology collection)
Patients undergo anal cytology collection using 2 NF swabs and 1 Dacron swab for analysis via Pap staining, HPV genotyping, and PCR.
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Accuracy of cytology specimens for Dacron swab compared to flocked nylon (NF) swab in predicting histology outcome
时间窗: Baseline
Two contingency tables will contrast cytology classification (for each swab type) with anal intraepithelial neoplasia (AIN) diagnosis based upon high-resolution anoscopy (HRA) \& histology.
次要结局
- Ability of Hybrid-capture 2 to predict risk for HG-AIN(Baseline)
- Cost effectiveness analysis evaluating differences in survival, the cost of out-patient procedures & in-patient hospitalizations for invasive anal cancer.(Up to 3 years)
- Ability of APTIMA-HPV to predict risk for HG-AIN(Baseline)