High Resolution Anuscopy Study

February 14, 2025 updated by: Universitair Ziekenhuis Brussel

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients who underwent or will undergo High Resolution Anoscopy in UZ Brussel after Informed Consent

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitair Ziekenhuis Brussel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2024

Primary Completion (Estimated)

July 1, 2029

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

September 19, 2024

First Submitted That Met QC Criteria

November 19, 2024

First Posted (Actual)

November 20, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 14, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRA Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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