Prevalence and Clinical Implications of HPV Infection in Male IBD Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-79
SponsorFundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed Crohn's disease or ulcerative colitis (at least 3 months before enrollment)
Male
Age from 18 to 79 years
Disqualifiers
Unclassified Inflammatory Bowel Disease
Diarrhea (> 3 bowel movements/day) with rectal bleeding at enrollment
Prior full proctectomy
Inability to collect the biological samples
Trial population
Male IBD patients referring to the IBD Clinic of Hospital de la Santa Creu i Sant Pau
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Anal pap smear and oral swab for cytology and HPV testing
Diagnostic testAnal and oral swab sampling for HPV detection (polymerase chain reaction) and cytology
Treatment groups
384 Participants
are divided into 1 treatment groupGroup A: Male IBD patients1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 12 months2
Prevalence (number/percentage) of abnormal HPV-related cytology in oral and anal samples
Cytology changes will be reported according to the Bethesda classification.
Time frame
Up to 12 monthsSecondary outcomes
1
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
Time frame
Up to 12 monthsSponsors and contacts
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Source ClinicalTrials.gov