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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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05060640
Study type Observational
Source University Fernando Pessoa
Contact Andreia Albuquerque, MD PhD
Phone 00351222455455
Email [email protected]
Status Recruiting
Phase
Start date August 26, 2021
Completion date August 31, 2024

See also
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Recruiting NCT03357991 - E6/E7 mRNA Performance to Detect HSIL and Cost-effectiveness Analysis of This Screening Strategy in HIV + MSM N/A
Completed NCT03697226 - Study of Topical ABI-1968 in Subjects With Precancerous Cervical Lesions From Human Papillomavirus (HPV) Infection. Phase 1