Screening Strategies Among High-risk Populations for Anal Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neoplasms
- Sponsor
- Lisa Flowers
- Enrollment
- 500
- Locations
- 4
- Primary Endpoint
- Specificity and Sensitivity of screening markers
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Lisa Flowers
Professor of Medicine
Emory University
Eligibility Criteria
Inclusion Criteria
- •30-80 years of age
- •Individuals with chronic impaired immune status
- •History of high-grade lower genital tract neoplasia (LGTN), Zubrod Performance Status of 0-2;
Exclusion Criteria
- •Patients treated for aHSIL less than 6 months before screening,
- •History of anal cancer and pregnant women.
Outcomes
Primary Outcomes
Specificity and Sensitivity of screening markers
Time Frame: 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.
Secondary Outcomes
- 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)