High Resolution Anuscopy Study

NCT06697964 | Recruiting

• 1 other identifier: HRA Study
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Papilloma Virus; Anal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (6)

• 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

  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

  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

Interventions

HRA OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• None

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Jette, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Anus Neoplasms

Condition Hierarchy (Ancestors)

Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases

Central Study Contacts

Magali Surmont

CONTACT

+32 2 477; magali.surmont@uzbrussel.be

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: November 20, 2024
• Study Start: August 8, 2024
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: February 19, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)