ANAL PRECANCEROUS LESIONS IN HIGH-RISK PATIENTS.

NCT05060640 | Unknown

• 1 other identifier: 78A
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

AIN3; AIN2; HSIL, High Grade Squamous Intraepithelial Lesions

Outcome Measures

Primary Outcomes (1)

• Prevalence of anal high-grade squamous intraepithelial lesions in the squamocolumnar junction detected during routine colonoscopy.

  through study completion, an average of 3 years

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HIV-positive patients, women with genital neoplasia (cervix, vulva and vagina), solid organ transplanted recipients, patients with inflammatory bowel disease and patients with Lupus.

You may qualify if:

• HIV-positive patients
• Solid transplanted recipients
• Crohn's disease patients under immunosuppression: steroids, thiopurines, biologics
• Patients with lupus under immunosuppression
• Women with a previous history of genital neoplasia (high-grade lesions or cancer) in the cervix, vagina or vulva.

You may not qualify if:

• Previous anal/perianal cancer history
• Previous known history of anal/perianal intraepithelial neoplasia
• Pelvic radiation

Sponsors & Collaborators

• University Fernando Pessoa: lead

Study Sites (1)

Fernando Pessoa Teaching Hospital

Gondomar, Porto District, 4420-096, Portugal

RECRUITING

MeSH Terms

Conditions

Squamous Intraepithelial Lesions

Condition Hierarchy (Ancestors)

Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Andreia Albuquerque, MD PhD

CONTACT

00351222455455; a.albuquerque.dias@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: September 29, 2021
• Study Start: August 26, 2021
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: December 12, 2022

Record last verified: 2022-12

Locations

PT (1)