PACCO: ANAL PRECANCEROUS LESIONS IN HIGH-RISK PATIENTS.

• Sponsor: University Fernando Pessoa (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05060640
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Anticipated Duration (Months): 36.2
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
AIN3; AIN2; HSIL, High Grade Squamous Intraepithelial Lesions	Procedure: Detection of anal HSIL in a routine colonoscopy.

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).

Study Design

• Study Type: Observational
• Anticipated Enrollment: 100 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: PREVALENCE OF ANAL PRECANCEROUS LESIONS IN HIGH-RISK PATIENTS DETECTED BY ROUTINE COLONOSCOPY (PACCO STUDY)
• Actual Study Start Date: Aug 26, 2021
• Anticipated Primary Completion Date: Aug 31, 2024
• Anticipated Study Completion Date: Aug 31, 2024

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fernando Pessoa Teaching Hospital	Gondomar	Porto	Portugal	4420-096

Sponsors and Collaborators

• University Fernando Pessoa

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Fernando Pessoa
• ClinicalTrials.gov Identifier: NCT05060640
• Other Study ID Numbers: 78A
• First Posted: Sep 29, 2021
• Last Update Posted: Sep 29, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Squamous Intraepithelial Lesions of the Cervix; Carcinoma, Squamous Cell; Carcinoma in Situ

Study Results

No Results Posted as of Sep 29, 2021