Skip to content

ANAL PRECANCEROUS LESIONS IN HIGH-RISK PATIENTS.

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05060640
Acronym
PACCO
Enrollment
100
Registered
2021-09-29
Start date
2021-08-26
Completion date
2024-08-31
Last updated
2022-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AIN2, AIN3, HSIL, High Grade Squamous Intraepithelial Lesions

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).

Interventions

PROCEDUREDetection of anal HSIL in a routine colonoscopy.

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

Sponsors

University Fernando Pessoa
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

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

Countries

Portugal

Contacts

Primary ContactAndreia Albuquerque, MD PhD
a.albuquerque.dias@gmail.com00351222455455

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026