Prevalence and Clinical Implications of HPV Infection in Male IBD Patients

Recruiting

• Conditions: Dysplasia Anus; HPV Infection; Oral Cavity Disease
• Interventions: Diagnostic Test: Anal pap smear and oral swab for cytology and HPV testing

• Registration Number: NCT05911750
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

The study aims at describing the prevalence of Human Papillomavirus (HPV) infection in anal and oral samples of men with Inflammatory Bowel Disease (IBD) and detecting risk factors for the infection.

Detailed Description

Male IBD patients attending the IBD Clinic of Hospital de la Santa Creu i Sant Pau will be screened for eligibility. Informed consent will be obtained from all eligible patients. An anal and oral swab will be performed on all patients to look for HPV infection (HPV DNA test) and cytologic alterations. Patients will be inspected to rule out the presence of HPV-related lesions. Moreover, a self-administered questionnaire will be completed by all enrolled patients. Information regarding IBD characteristics and treatment will be obtained.

According to local practice, patients with anal or oral squamous intraepithelial lesions (ASIL) will be referred to a colorectal surgeon for further recommendations or treatment.

Study Timeline

• Study Start: 2023-02-12
• Study First Submitted: 2023-05-30
• Status Verified: 2023-06
• Study First Submitted QC: 2023-06-10
• Study First Posted: 2023-06-22
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-15
• Primary Completion: 2024-12-01
• Study Completion: 2025-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 384

Inclusion Criteria

• Diagnosed Crohn's disease or ulcerative colitis (at least 3 months before enrollment)
• Male
• Age from 18 to 79 years

Exclusion Criteria

• Unclassified Inflammatory Bowel Disease
• Diarrhea (> 3 bowel movements/day) with rectal bleeding at enrollment
• Prior full proctectomy
• Inability to collect the biological samples
• Inability to complete the questionnaire
• Refusal to sign the informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Male IBD patients	Anal pap smear and oral swab for cytology and HPV testing	Male patients with a confirmed diagnosis of Inflammatory Bowel Disease (Crohn´s disease or Ulcerative colitis).

Primary Outcome Measures

Name	Time	Method
Prevalence (number/percentage) of HPV infection in oral and anal samples	Up to 12 months	PCR analysis will identify the presence of HPV in oral or anal mucosal cells and characterize the genotype of HPV.
Prevalence (number/percentage) of abnormal HPV-related cytology in oral and anal samples	Up to 12 months	Cytology changes will be reported according to the Bethesda classification.

Secondary Outcome Measures

Name	Time	Method
Multivariate analysis to identify risk factors for HPV infection in oral and anal samples.	Up to 12 months	Risk factors such as demographics, sexual conduct, and factors related to Inflammatory Bowel Disease (IBD) and IBD therapy will be evaluated through patient history research and the use of a self-administered questionnaire

Trial Locations

Locations (1)

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain