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Recruiting NCT06697964

High Resolution Anuscopy Study

— Observational Human Papilloma Virus Anal Squamous Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HRA.
Who it may be relevant to
Registry conditions: Human Papilloma Virus, Anal Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

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

Primary outcome measures

  • 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]
  • Exploration of associations between abnormal histology and patient characteristics [Time frame: 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]
  • 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]
  • Prevalence of anal cancer among the at-risk populations [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Belgium · 1 center
  • UZ Brussel — Jette

Identifiers

NCT: NCT06697964 · HRA Study

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗