Clinical trial · Observational
Prevalence and Clinical Implications of HPV Infection in Male IBD Patients
Prevalence and Clinical Implications of Human Papillomavirus Infection in the Male Population With Inflammatory Bowel Disease
NCT05911750CI-TRIAL-00095058PAPIMALErecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Dysplasia Anus | — | UNRESOLVED | — |
| HPV Infection | — | UNRESOLVED | — |
| Oral Cavity Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anal pap smear and oral swab for cytology and HPV testing | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Male IBD patients
- description
- Male patients with a confirmed diagnosis of Inflammatory Bowel Disease (Crohn´s disease or Ulcerative colitis).
- interventionNames
- Diagnostic Test: Anal pap smear and oral swab for cytology and HPV testing
Primary outcomes (2)
- measure
- Prevalence (number/percentage) of HPV infection in oral and anal samples
- timeFrame
- Up to 12 months
- description
- PCR analysis will identify the presence of HPV in oral or anal mucosal cells and characterize the genotype of HPV.
- measure
- Prevalence (number/percentage) of abnormal HPV-related cytology in oral and anal samples
- timeFrame
- Up to 12 months
- description
- Cytology changes will be reported according to the Bethesda classification.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 79 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.