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ANAL PRECANCEROUS LESIONS IN HIGH-RISK PATIENTS.

NCT ID: NCT05060640

Last Updated: 2022-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-26

Study Completion Date

2024-08-31

Brief Summary

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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

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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).

Conditions

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AIN3 AIN2 HSIL, High Grade Squamous Intraepithelial Lesions

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Detection of anal HSIL in a routine colonoscopy.

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Fernando Pessoa

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fernando Pessoa Teaching Hospital

Gondomar, Porto District, Portugal

Site Status RECRUITING

Countries

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Portugal

Central Contacts

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Andreia Albuquerque, MD PhD

Role: CONTACT

Phone: 00351222455455

Email: [email protected]

Facility Contacts

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Andreia Albuquerque, MD PhD

Role: primary

Other Identifiers

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78A

Identifier Type: -

Identifier Source: org_study_id