ANAL PRECANCEROUS LESIONS IN HIGH-RISK PATIENTS.

NCT05060640 — Unknown, 100 participants, University Fernando Pessoa

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

Registry	NCT05060640, acronym PACCO
Status	Unknown
Study type	Observational
Enrollment	100 (Estimated)
Sponsor	University Fernando Pessoa (Other)
Conditions	AIN3, AIN2, HSIL, High Grade Squamous Intraepithelial Lesions
Interventions	Detection of anal HSIL in a routine colonoscopy. (Procedure)
Dates	start 2021-08-26, primary completion 2024-08-31 (estimated), completion 2024-08-31 (estimated), first posted 2021-09-29, last updated 2022-12-12
Locations	1 site in Portugal

-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.

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+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).

+Arms and interventions

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

+Outcome measures

Primary outcomes

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

+Eligibility

Sex: All

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

+Locations (1)

Facility	City	Country	Status
Fernando Pessoa Teaching Hospital	Gondomar, Porto District	Portugal	Recruiting