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Recruiting

NCT Number: NCT06697964

High Resolution Anuscopy Study

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.

Recruiting

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Key information

Conditions

Human Papilloma Virus Anal Squamous Cell Carcinoma Anus Diseases Anus Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Brussel

Jette, 1090, Belgium

Location status: Recruiting

Location contact

Magali Surmont

CONTACT

[email protected]

+32 2 477 ext. 60 11

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HRA

Other

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

Primary outcomes

  1. 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

  2. Exploration of associations between abnormal histology and patient characteristics

    Time frame: Through study completion, on average 5 years

  3. comparison of the prevalence of precancerous lesions in different groups

    Time frame: Through study completion, on average 5 years

  4. 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

  5. Prevalence of anal cancer among the at-risk populations

    Time frame: Through study completion, on average 5 years

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Magali Surmont

CONTACT

[email protected]

+32 2 477 ext. 60 11

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Nov 20, 2024
Registry last updated
Feb 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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