ANAL PRECANCEROUS LESIONS IN HIGH-RISK PATIENTS. — PACCO  

HSIL, High Grade Squamous Intraepithelial Lesions Clinical Trial

Official title: PREVALENCE OF ANAL PRECANCEROUS LESIONS IN HIGH-RISK PATIENTS DETECTED BY ROUTINE COLONOSCOPY (PACCO STUDY)

Status Recruiting

Clinical Trial 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Carcinoma in Situ
• Carcinoma, Squamous Cell
• HSIL, High Grade Squamous Intraepithelial Lesions
• Squamous Intraepithelial Lesions of the Cervix

• NCT number: NCT05060640
• Study type: Observational
• Source: University Fernando Pessoa
• Contact: Andreia Albuquerque, MD PhD
• Phone: 00351222455455
• Email: a.albuquerque.dias@gmail.com
• Status: Recruiting
• Start date: August 26, 2021
• Completion date: August 31, 2024