Prevalence and Clinical Implications of HPV Infection in Male IBD Patients

NCT05911750 | Recruiting

• 1 other identifier: IIBSP-VHP-2023-47
• Study Type: observational
• Target: 384
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

HPV Infection; Dysplasia Anus; Oral Cavity Disease

Keywords

HPV, oral swab, anal swab

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 12 months

Secondary Outcomes (1)

• Multivariate analysis to identify risk factors for HPV infection in oral and anal samples.

  Up to 12 months

Study Arms (1)

Male IBD patients

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

Interventions

Anal pap smear and oral swab for cytology and HPV testing DIAGNOSTIC_TEST

Anal and oral swab sampling for HPV detection (polymerase chain reaction) and cytology

Male IBD patients

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Male IBD patients referring to the IBD Clinic of Hospital de la Santa Creu i Sant Pau

You may qualify if:

• Diagnosed Crohn's disease or ulcerative colitis (at least 3 months before enrollment)
• Male
• Age from 18 to 79 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead

Study Sites (1)

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Barcelona, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Rectal and oral mucosal cells collected by anal and oral swab, respectively.

MeSH Terms

Conditions

Papillomavirus Infections; Mouth Diseases

Interventions

Cytological Techniques

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Antonio Giordano, MD

  dr.antoniogiordano@gmail.com

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonio Giordano, MD

CONTACT

0034 932919000; dr.antoniogiordano@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 22, 2023
• Study Start: February 12, 2023
• Primary Completion: January 31, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: September 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)