About this trial
The incidence of anal cancer is increasing, particularly among high-risk groups such as men who have sex with men (MSM), especially those living with HIV. The lack of comprehensive screening programs results in delayed diagnosis and higher mortality.
This project aims to establish a screening program for anal cancer in high-risk populations, with a specific focus on those most at risk. Using a prospective study design, the project will assess the effectiveness of early detection and prevention strategies to potentially reduce cancer incidence and improve survival rates. If an HPV-based screening method proves effective, it would serve as a potential implemention for high-risk groups in Denmark, further enhancing early detection and prevention efforts.
This study represents the first large-scale, prospective screening initiative for anal cancer in Denmark,specifically targeting MSM. It introduces a novel approach to cancer prevention in this population by building on research in other cancers and adapting it to anal cancer and its specific risk factors.
The project is a collaboration between clinical practitioners and academic researchers, ensuring that practical clinical insights guide the research and that research findings are rapidly translated into clinical practice. This partnership will enhance both the quality of the research and its direct application in healthcare.
The project is expected to lead to earlier diagnosis of anal cancer, reduced morbidity and mortality among high-risk populations, and the establishment of a screening model that can be applied nationwide. This could significantly reduce the overall healthcare burden associated with late-stage anal cancer and improve patient outcomes across Denmark.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
MSM with HIV
HIV-negative MSMonPrEP
Age >=35 years
Written and orally informed consent in English or Danish
Disqualifiers
Previous anal cancer
Rectum extirpation (of any cause)
Unwilling to have HRA performed
Inflammatory bowel disease
Trial design
Sequential
Treatments tested in this trial
High resolution anoscopy
Diagnostic testto study biomarkers for anal cancer screening
Treatment groups
Trial outcomes
Primary outcomes
Anal HSIL prevalence and incidence
Anal HSIL defined as the result of findings on HRA confirmed histologically at baseline and 1-year follow-up in HIV positive MSM compared to MSM on PrEP
Anal high-risk HPV infection
Anal HPV infection defined as the result of anal HPV test, including prevalence, incidence, and persistent infections.MSM living with HIV compared to MSM on PrEP
Secondary outcomes
The diagnostic potential of biomarkers (p16/ki67 dual stain cytology, DNA methylation analysis and pHPV).
Performance of HPV test, anal cytology, and biomarkers (p16/Ki-67 dual stain, DNA methylation analysis, pHPV), sensitivities and specificities to predict anal HSIL.
Anal warts prevalence and incidence
Anal and perianal warts defined as findings on HRA confirmed histologically inMSM living with HIV compared to MSM on PrEP
Other outcomes
Performance of HPV self-test compared to professional collected anal samples
The diagnostic accuracy and feasibility of HPV analysis on self-collected anal samples compared to HPV analysis on professionally collected cell samples for 15% of the participants
Locations
Sponsors and contacts
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Bispebjerg Hospital
Lead sponsor
Vejle Hospital
Collaborator
Aarhus University Hospital
Collaborator
Odense University Hospital
Collaborator
Hvidovre University Hospital
Collaborator
Rigshospitalet, Denmark
Collaborator
This trial is not recruiting at the moment. You can still explore other options: