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NCT07123558Not yet recruiting

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

Anal Cancer Prevention in High-Risk Categories of Men Who Have Sex With Men - A Danish Prospective Study

Source: ClinicalTrials.gov · Last updated 14 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
700 (estimated)
First submitted
11 Jul 2025
Start date
1 Nov 2025
Primary completion date
31 Oct 2026
Lead sponsor
Bispebjerg Hospital
Diseases
HIV
NCT number
NCT07123558

What you commit to

  • Study type: Interventional
  • Planned participants: 700
  • From 1 Nov 2025 to the primary completion date, 31 Oct 2026
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous anal cancer

Other illness

  • Inflammatory bowel disease
  • Other known immunosuppressive disorder than HIV

Other

  • Rectum extirpation (of any cause)
  • Unwilling to have HRA performed
  • Inability and unwillingness to give informed consent
  • No sex with men

Who the study is looking for

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

Age in the registry: 35 years to - · Sex: Male · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.