NCT05911750

Prevalence and Clinical Implications of HPV Infection in Male IBD Patients

Prevalence and Clinical Implications of Human Papillomavirus Infection in the Male Population With Inflammatory Bowel Disease

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 384 (estimated)
• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Academic / Other
• Sex: Male
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HPV Infection
• Dysplasia Anus
• Oral Cavity Disease

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Anal pap smear and oral swab for cytology and HPV testing	Anal and oral swab sampling for HPV detection (polymerase chain reaction) and cytology

Timeline

• Start date: 2023-02-12
• Primary completion: 2026-01-31
• Completion: 2026-06-01
• First posted: 2023-06-22
• Last updated: 2025-09-12

Locations

1 site across 1 country: Spain