Actively Recruiting
Prevalence and Clinical Implications of Human Papillomavirus Infection in the Male Population With Inflammatory Bowel Disease
Led by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau · Updated on 2025-09-12
384
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the occurrence of Human Papillomavirus (HPV) infection in anal and oral samples of men with Inflammatory Bowel Disease (IBD), including Crohn's disease and ulcerative colitis. The study aims to describe how common HPV infection is in this population and to identify factors that may increase the risk of infection. This observational study is sponsored by the Fundaci f3 Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau and focuses on male patients aged 18 to 79 years with a confirmed IBD diagnosis. Male patients attending the IBD clinic will undergo anal and oral swab sampling to test for HPV DNA and check for cellular changes using cytology. Patients will also be examined for any HPV-related lesions. Those found with anal or oral squamous intraepithelial lesions will be referred to a colorectal surgeon for further evaluation or treatment. Participants will complete a self-administered questionnaire, and information about their IBD condition and treatments will be collected. During the study, researchers will measure the prevalence of HPV infection and abnormal cytology in oral and anal samples over a period of up to 12 months. They will also perform analysis to identify risk factors linked to HPV infection. The study involves sample collection, clinical examinations, questionnaires, and medical data review. Participants' consent will be obtained before enrollment, and their involvement includes tests and surveys to better understand HPV infection in men with IBD.
CONDITIONS
Brief Title
Prevalence and Clinical Implications of HPV Infection in Male IBD Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed Crohn's disease or ulcerative colitis for at least 3 months before enrollment
- Male
- Age from 18 to 79 years
You will not qualify if you...
- Unclassified Inflammatory Bowel Disease
- Diarrhea with more than 3 bowel movements per day and rectal bleeding at enrollment
- Prior full proctectomy
- Inability to collect the biological samples
- Inability to complete the questionnaire
- Refusal to sign the informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants undergo anal and oral swab sampling and cytology to detect HPV infection and cytologic alterations. They are also inspected for HPV-related lesions and complete a self-administered questionnaire.
1 visit (in-person)
Duration - Up to 12 months
Participants with anal or oral squamous intraepithelial lesions (ASIL) may be referred for further recommendations or treatment according to local practice.
Follow-up visits as needed depending on clinical findings
Trial Site Locations
Total: 1 location
1
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Actively Recruiting
Research Team
A
Antonio Giordano, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here