Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anal AIN3 | — | UNRESOLVED | — |
| Anal HPV Infection | — | UNRESOLVED | — |
| Anal HSIL | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High resolution anoscopy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- High resolution anoscopy
- description
- 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)
- interventionNames
- Diagnostic Test: High resolution anoscopy
Primary outcomes (2)
- measure
- Anal HSIL prevalence and incidence
- timeFrame
- 1 year
- description
- 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
- measure
- Anal high-risk HPV infection
- timeFrame
- 1-2 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * MSM with HIV * HIV-negative MSMonPrEP * Age \>=35 years * Written and orally informed consent in English or Danish Exclusion criteria * 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
References
Publications (31)
- BACKGROUNDGroup DAC. NOAC 9 - A Phase III Randomized Nordic Anal Cancer Group Study on Circu-lating Tumor DNA guided Follow-Up. https://wwwdcccdk/english/projectsandnetwork/noac-9---a-phase-iiirandomized-nordic-anal-cancer-group-study-on-circulating-tumor-dna-guided-follow-up/.
- BACKGROUNDvan der Zee RP, van Noesel CJM, Martin I, Ter Braak TJ, Heideman DAM, de Vries HJC, Prins JM, Steenbergen RDM. DNA methylation markers have universal prognostic value for anal cancer risk in HIV-negative and HIV-positive individuals. Mol Oncol. 2021 Nov;15(11):3024-3036. doi: 10.1002/1878-0261.12926. Epub 2021 Mar 16. PMID 33580586
- BACKGROUNDSwanson AA, Hartley C, Long ME, Chantigian PDM, Casey PM, Jenkins SM, Boerger AC, Binnicker MJ, Henry MR. Evaluation of high-risk human papillomavirus testing and anal cytology to detect high-grade anal intraepithelial neoplasia. J Am Soc Cytopathol. 2021 Jul-Aug;10(4):406-413. doi: 10.1016/j.jasc.2021.03.007. Epub 2021 Apr 6. PMID 33896747
- BACKGROUNDGoncalves JCN, Macedo ACL, Madeira K, Bavaresco DV, Dondossola ER, Grande AJ, da Rosa MI. Accuracy of Anal Cytology for Diagnostic of Precursor Lesions of Anal Cancer: Systematic Review and Meta-analysis. Dis Colon Rectum. 2019 Jan;62(1):112-120. doi: 10.1097/DCR.0000000000001231. PMID 30451747
- BACKGROUNDHopp AM, Pant M, Sniedze S, Parsons LN, Hunt B, Giorgadze T. Correlation of anal cytology with follow-up histology and Human Papillomavirus genotyping: A 10-year experience from an academic medical center. Ann Diagn Pathol. 2021 Feb;50:151670. doi: 10.1016/j.anndiagpath.2020.151670. Epub 2020 Nov 20. PMID 33310590
- BACKGROUNDPatarapadungkit N, Khonhan P, Pisuttimarn P, Pientong C, Ekalaksananan T, Koonmee S. Human Papillomavirus Detection and Abnormal Anal Cytology in HIV-infected Patients Using p16/Ki-67 Dual-Staining. Asian Pac J Cancer Prev. 2020 Jul 1;21(7):2013-2019. doi: 10.31557/APJCP.2020.21.7.2013. PMID 32711427