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.
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 Type
OBSERVATIONAL
Enrollment
384
Anal and oral swab sampling for HPV detection (polymerase chain reaction) and cytology
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
RECRUITINGPrevalence (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 months
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 months
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 months
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