An observational study in HPV Infection, Dysplasia Anus and Oral Cavity Disease, sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau. Recruiting at 1 site in Spain. Open to male participants aged 18 Years to 79 Years. Per ClinicalTrials.gov, last updated 2025-09-12.
Sponsored by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Observational
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.
576 studies on the registry are indexed under Papillomavirus Infections; 132 are open to participants now.
This study's planned enrollment of 384 is below the median of 490 across 157 observational studies indexed under Papillomavirus Infections.
Browse Papillomavirus Infections studies →Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau is the lead sponsor of 343 studies on the registry; 65 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Male IBD patients referring to the IBD Clinic of Hospital de la Santa Creu i Sant Pau
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Anal and oral swab sampling for HPV detection (polymerase chain reaction) and cytology
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 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
Plan to share: No — IPD will be only shared upon request and with IEC approval.
No publications or documents are linked to this record.
Started Feb 2023 (actual). Primary completion is estimated for Jan 2026, 35 months after the start.
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