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

NCT07123558 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2025-08-14

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

High resolution anoscopy

to study biomarkers for anal cancer screening

Sponsors & Collaborators

  • Vejle Hospital

    collaborator OTHER
  • Aarhus University Hospital

    collaborator OTHER
  • Odense University Hospital

    collaborator OTHER
  • Hvidovre University Hospital

    collaborator OTHER
  • Rigshospitalet, Denmark

    collaborator OTHER
  • Bispebjerg Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
35 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-01
Primary Completion
2026-10-31
Completion
2027-10-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07123558 on ClinicalTrials.gov