Screening Strategies Among High-risk Populations for Anal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 8
- 主要终点
- Specificity and Sensitivity of screening markers
研究概览
简要总结
The goal of the proposed research is to 1) examine the performance of emerging screening methods for anal high-grade squamous intraepithelial lesion (aHSIL), a precancerous condition of anal cancer, among populations at high risk for anal cancer and 2) characterize DNA methylation, immunologic response, and environmental factors associated with aHSIL.
详细描述
Anal cancer, caused by persistent infection with high-risk human papillomavirus (hrHPV), is typically preceded by anal high-grade squamous intraepithelial lesions (aHSIL). The incidence and mortality of advanced anal cancer has been increasing in the U.S., with the greatest burden of disease and mortality in individuals with chronic impairment of the immune system. The study is important because the incidence of anal cancer is particularly high among certain groups. Findings will provide much-needed evidence for anal cancer screening strategies to reduce incidence of anal cancer and improve health outcomes. The study population includes individuals with chronic impairment of the immune system and females with a known history of high-grade lower genital tract neoplasia.
The study procedures include filling out self-reported questionnaires and collecting biosamples for study-related assays. HRA is part of the standard clinic procedure for this group of participants. Collected biosamples will be banked for future research use. In-person or remote signed consent may occur for the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •30-80 years of age
- •Individuals with chronic impaired immune status
- •History of lower genital tract neoplasia (LGTN), Zubrod Performance Status of 0-2
排除标准
- •Patients treated for aHSIL less than 6 months before screening
- •History of anal cancer and pregnant women.
研究组 & 干预措施
Women with impaired immune status and and lower genital tract neoplasia (LGTN)
At each study visit, participants will receive a digital anorectal examination followed by HRA, with directed biopsies of suspicious lesions. An HRA-certified physician will collect anal swabs and HRA-directed biopsies for histological confirmation of disease and biomarker assays.
干预措施: HRA + Biopsy (Diagnostic Test)
Women with impaired immune status and and lower genital tract neoplasia (LGTN)
At each study visit, participants will receive a digital anorectal examination followed by HRA, with directed biopsies of suspicious lesions. An HRA-certified physician will collect anal swabs and HRA-directed biopsies for histological confirmation of disease and biomarker assays.
干预措施: Anal Cytology (Diagnostic Test)
Men with impaired immune status
At each study visit, participants will receive a digital anorectal examination followed by HRA, with directed biopsies of suspicious lesions. An HRA-certified physician will collect anal swabs and HRA-directed biopsies for histological confirmation of disease and biomarker assays.
干预措施: HRA + Biopsy (Diagnostic Test)
Men with impaired immune status
At each study visit, participants will receive a digital anorectal examination followed by HRA, with directed biopsies of suspicious lesions. An HRA-certified physician will collect anal swabs and HRA-directed biopsies for histological confirmation of disease and biomarker assays.
干预措施: Anal Cytology (Diagnostic Test)
Men with impaired immune status
At each study visit, participants will receive a digital anorectal examination followed by HRA, with directed biopsies of suspicious lesions. An HRA-certified physician will collect anal swabs and HRA-directed biopsies for histological confirmation of disease and biomarker assays.
干预措施: Genotyping of anal hrHPV infection (Diagnostic Test)
Men with impaired immune status
At each study visit, participants will receive a digital anorectal examination followed by HRA, with directed biopsies of suspicious lesions. An HRA-certified physician will collect anal swabs and HRA-directed biopsies for histological confirmation of disease and biomarker assays.
干预措施: CINtec®PLUS (Diagnostic Test)
Men without impaired immune status
At each study visit, participants will receive a digital anorectal examination followed by HRA, with directed biopsies of suspicious lesions. An HRA-certified physician will collect anal swabs and HRA-directed biopsies for histological confirmation of disease and biomarker assays.
干预措施: HRA + Biopsy (Diagnostic Test)
Men without impaired immune status
At each study visit, participants will receive a digital anorectal examination followed by HRA, with directed biopsies of suspicious lesions. An HRA-certified physician will collect anal swabs and HRA-directed biopsies for histological confirmation of disease and biomarker assays.
干预措施: Anal Cytology (Diagnostic Test)
Men without impaired immune status
At each study visit, participants will receive a digital anorectal examination followed by HRA, with directed biopsies of suspicious lesions. An HRA-certified physician will collect anal swabs and HRA-directed biopsies for histological confirmation of disease and biomarker assays.
干预措施: Genotyping of anal hrHPV infection (Diagnostic Test)
结局指标
主要结局
Specificity and Sensitivity of screening markers
时间窗: Baseline
Sensitivity and specificity will be calculated for each of the proposed screening markers separately and a combination of two and three markers for the detection of aHSIL at baseline. The combination of the two and three markers of primary interest includes CINtec®PLUS +hrHPV, CINtec®PLUS+anal cytology, hrHPV+anal cytology, and CINtec®PLUS+hrHPV+anal cytology. The analysis will be performed for the four high-risk groups together and stratified by the four high-risk categories.
次要结局
- DNA methylation markers(Baseline, 1 year, 2 years)
- Anal immune modulations(Baseline, 1 year, 2 years)
- aHSIL prevalence(Baseline)
- aHSIL clearance(1 year, 2 years)
- Inflammatory Markers (Il-1RA, IL1β, IL6, IL6sr, TNF-α, and IL-10)(Baseline, 1 year, 2 years)
- Inflammatory Markers (sTNFR2 and interferon (IFN)-γ)(Baseline, 1 year, 2 years)
- Inflammatory Marker (CRP)(Baseline, 1 year, 2 years)
研究者
Lisa Flowers
Professor of Medicine
Emory University