ANAL PRECANCEROUS LESIONS IN HIGH-RISK PATIENTS.

Recruiting

• Conditions: AIN3; HSIL, High Grade Squamous Intraepithelial Lesions; AIN2

• Registration Number: NCT05060640
• Lead Sponsor: University Fernando Pessoa

Brief Summary

HIV-positive patients, women with a history of genital neoplasia and patients under pharmacologically immunosuppression (e.g. transplanted recipients, Crohn´s disease and Lupus) are a high-risk population for anal human-papillomavirus infection and associated complications, like anal precancerous lesions and anal squamous cell carcinoma. There is a lack of information on the prevalence of anal precancerous detected by routine colonoscopy in this population, by evaluating the squamocolumnar junction (the most susceptible area for lesions) during this procedure. Given, the increasing incidence rates of anal squamous cell carcinoma expected for the next two decades and the increase number of at-risk patients, the possible benefit of routine endoscopy in the diagnosis of anal precancerous lesions needs to be further explored.

Detailed Description

Procedures in all patients:

1. Digital anorectal evaluation

2. Colonoscopy with retroflection and visualization of the anal squamocolumnar junction

3. After identification of this area 5% acetic acid will be applied.

4. Visualization under NBI/BLI.

5. Biopsies of all the suspected lesions of anal high-grade squamous lesions (HSIL).

Study Timeline

• Study Start: 2021-08-26
• Study First Submitted: 2021-09-17
• Study First Submitted QC: 2021-09-28
• Study First Posted: 2021-09-29
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-09
• Last Update Posted: 2022-12-12
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. HIV-positive patients
2. Solid transplanted recipients
3. Crohn's disease patients under immunosuppression: steroids, thiopurines, biologics
4. Patients with lupus under immunosuppression
5. Women with a previous history of genital neoplasia (high-grade lesions or cancer) in the cervix, vagina or vulva.

Exclusion Criteria

1. Previous anal/perianal cancer history
2. Previous known history of anal/perianal intraepithelial neoplasia
3. Pelvic radiation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of anal high-grade squamous intraepithelial lesions in the squamocolumnar junction detected during routine colonoscopy.	through study completion, an average of 3 years

Trial Locations

Locations (1)

Fernando Pessoa Teaching Hospital; 🇵🇹 Gondomar, Porto, Portugal