Anal Cancer Prevention in High-Risk Categories of Men Who Have Sex With Men

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age35+
SponsorBispebjerg Hospital

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 volunteers

Qualifiers

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

Design model

Sequential

Treatments tested in this trial

  • High resolution anoscopy

    Diagnostic test

    to study biomarkers for anal cancer screening

Treatment groups

700 Participants
are divided into 1 treatment group
Group A: High resolution anoscopyOther 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
1 year
2

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

Time frame
1-2 years

Secondary outcomes

1

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.

Time frame
1-2 years
2

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

Time frame
1-2 year

Other outcomes

1

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

Time frame
1 year

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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: