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High Resolution Anuscopy Study

High Resolution Anuscopy Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06697964
Enrollment
500
Registered
2024-11-20
Start date
2024-08-08
Completion date
2029-07-31
Last updated
2025-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Squamous Cell Carcinoma, Human Papilloma Virus

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.

Interventions

OTHERHRA

High resolution anoscopy to help evaluate anal conditions such as precancerous lesions

Sponsors

Universitair Ziekenhuis Brussel
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
comparison of the prevalence of precancerous lesions in men who have sex with men using PrEP or are HIV positive MenThrough study completion, on average 5 years
Exploration of associations between abnormal histology and patient characteristicsThrough study completion, on average 5 years
comparison of the prevalence of precancerous lesions in different groupsThrough study completion, on average 5 years
to delineate unique features associated with HSIL in each risk group by linking patterns or characteristicsThrough study completion, on average 5 yearssuch as verrucous aspects, coarse punctuation, mosaic patterns, flat morphology, and fragility
Prevalence of anal cancer among the at-risk populationsThrough 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 HIVThrough study completion, on average 5 years

Countries

Belgium

Contacts

Primary ContactMagali Surmont
magali.surmont@uzbrussel.be+32 2 477

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026