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

NCT07123558 | Not Yet Recruiting DMC

• 5 other identifiers: S-202400792024-0039No grant numberKC23-00598KC25-01568
• Study Type: interventional
• Target: 700
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Anal HSIL; Anal AIN3; Anal HPV Infection

Keywords

anal HSIL; HIV infection; MSM; anal HPV infection

Outcome Measures

Primary Outcomes (2)

• 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

  1 year

• 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

  1-2 years

Secondary Outcomes (2)

• The diagnostic potential of biomarkers (p16/ki67 dual stain cytology, DNA methylation analysis and pHPV).

  1-2 years

• Anal warts prevalence and incidence

  1-2 year

Other Outcomes (1)

• Performance of HPV self-test compared to professional collected anal samples

  1 year

Study Arms (1)

High resolution anoscopy

OTHER

MSM with or without HIV infection will be examined with high-resolution anoscopy for anal HSIL lesions and anal warts additionally with anal swabs for HPV and cytology and dual stain cytology, comparing the two groups over time (baseline and 1 year follow up visit)

Diagnostic Test: High resolution anoscopy

Interventions

High resolution anoscopy DIAGNOSTIC_TEST

to study biomarkers for anal cancer screening

Also known as: Anal cancer screening

High resolution anoscopy

Eligibility Criteria

• Age: 35 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• MSM with HIV
• HIV-negative MSMonPrEP
• Age \>=35 years
• Written and orally informed consent in English or Danish

You may not qualify if:

• Previous anal cancer
• Rectum extirpation (of any cause)
• Unwilling to have HRA performed
• Inflammatory bowel disease
• Inability and unwillingness to give informed consent
• Other known immunosuppressive disorder than HIV
• No sex with men

Sponsors & Collaborators

• Bispebjerg Hospital: lead
• Vejle Hospital: collaborator
• Aarhus University Hospital: collaborator
• Odense University Hospital: collaborator
• Hvidovre University Hospital: collaborator
• Rigshospitalet, Denmark: collaborator

Related Publications (31)

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MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: consultant

Model Details: a prospective cohort study

Study Record Dates

• First Submitted: July 11, 2025
• First Posted: August 14, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: August 14, 2025

Record last verified: 2025-08