ANAL PRECANCEROUS LESIONS IN HIGH-RISK PATIENTS.

HSIL, High Grade Squamous Intraepithelial Lesions Clinical Trial

— PACCO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05060640
• Other study ID #: 78A
• Status: Recruiting
• Start date: August 26, 2021
• Est. completion date: August 31, 2024

Study information

• Verified date: December 2022
• Source: University Fernando Pessoa
• Contact: Andreia Albuquerque, MD PhD
• Phone: 00351222455455
• Email: a.albuquerque.dias[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Detection of anal HSIL in a routine colonoscopy.
Detection of anal HSIL in a routine colonoscopy by using acetic acid and NBI/BLI.

Locations

Country	Name	City	State
Portugal	Fernando Pessoa Teaching Hospital	Gondomar	Porto

Sponsors (1)

Lead Sponsor	Collaborator
University Fernando Pessoa

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of anal high-grade squamous intraepithelial lesions in the squamocolumnar junction detected during routine colonoscopy.		through study completion, an average of 3 years