High Resolution Anuscopy Study

Recruiting

• Conditions: Human Papilloma Virus; Anal Squamous Cell Carcinoma

• Registration Number: NCT06697964
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

The majority of anal squamous cell carcinomas (SCC) stem from infection with high-risk human papillomavirus (HPV). Anal SCC is rare among the general population but affects several populations disproportionately.

High-risk groups are screened through anal swabs for anal cytology and detection of high risk human papillomavirus (HR HPV). HRA referral is recommended for individuals with abnormal cytology.

HRA represents the only method to identify precancerous lesions of the anal canal, with only few specialists knowledgeable about it.

At UZ Brussel, the investigators collected a wealth of data about HPV infection and its association with anal pathology. By establishing a comprehensive study, the investigators can delve into this data with specific research questions, conducting valuable research to provide answers to pressing clinical questions and contribute to advancements in medical understanding and treatment.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-08
• Study First Submitted: 2024-09-19
• Study First Submitted QC: 2024-11-19
• Study First Posted: 2024-11-20
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-19
• Primary Completion: 2029-07
• Study Completion: 2029-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• All patients who have undergone HRA and all future patients referred for HRA in UZ Brussel
• 18 years or older
• Understands and able to speak and write in French, Dutch or English

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
comparison of the prevalence of precancerous lesions in men who have sex with men using PrEP or are HIV positive Men	Through study completion, on average 5 years
Exploration of associations between abnormal histology and patient characteristics	Through study completion, on average 5 years
comparison of the prevalence of precancerous lesions in different groups	Through study completion, on average 5 years
to delineate unique features associated with HSIL in each risk group by linking patterns or characteristics	Through study completion, on average 5 years	such as verrucous aspects, coarse punctuation, mosaic patterns, flat morphology, and fragility
Prevalence of anal cancer among the at-risk populations	Through study completion, on average 5 years
correlation between abnormal histology and abnormal cytology, as well as HPV infection in MSM using PrEP and MSM living with HIV	Through study completion, on average 5 years

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Jette, Belgium