Prevalence and Clinical Implications of Human Papillomavirus Infection in the Male Population With Inflammatory Bowel Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- HPV Infection
- Sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
- Enrollment
- 384
- Locations
- 1
- Primary Endpoint
- Prevalence (number/percentage) of HPV infection in oral and anal samples
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosed Crohn's disease or ulcerative colitis (at least 3 months before enrollment)
- •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
Outcomes
Primary Outcomes
Prevalence (number/percentage) of HPV infection in oral and anal samples
Time Frame: 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
Time Frame: Up to 12 months
Cytology changes will be reported according to the Bethesda classification.
Secondary Outcomes
- Multivariate analysis to identify risk factors for HPV infection in oral and anal samples.(Up to 12 months)