Ireland
--:--IST
Recruiting Observational

Prevalence and Clinical Implications of HPV Infection in Male IBD Patients

NCT05911750 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2023-02-12
Last updated
2025-09-12

Condition(s) studied

HPV InfectionDysplasia AnusOral Cavity Disease

Investigational drug(s) / intervention(s)

Anal pap smear and oral swab for cytology and HPV testing

Anal pap smear and oral swab for cytology and HPV testing: Anal and oral swab sampling for HPV detection (polymerase chain reaction) and cytology

Study summary

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

Sex
MALE
Min age
18 Years
Max age
79 Years
Healthy volunteers
No
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

Primary outcome measure(s)

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

Trial sites (1)

FacilityCityRegionStatus
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau Barcelona Spain Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05911750 on ClinicalTrials.gov ↗ ← All trials in Spain