Prevalence and Clinical Implications of HPV Infection in Male IBD Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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HPV Infection, Dysplasia Anus, Oral Cavity Disease

Intervention / Treatment
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* Diagnostic Test: Anal pap smear and oral swab for cytology and HPV testing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Male IBD patients<br>Male patients with a confirmed diagnosis of Inflammatory Bowel Disease (Crohn´s disease or Ulcerative colitis). | Diagnostic Test: Anal pap smear and oral swab for cytology and HPV testing<br>* Anal and oral swab sampling for HPV detection (polymerase chain reaction) and cytology<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multivariate analysis to identify risk factors for HPV infection in oral and anal samples. | 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 | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HPV, oral swab, anal swab