Prevalence and Clinical Implications of HPV Infection in Male IBD Patients (PAPIMALE)

Prevalence and Clinical Implications of Human Papillomavirus Infection in the Male Population With Inflammatory Bowel Disease

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.

Study Overview

• Status: Recruiting
• Conditions: HPV Infection; Oral Cavity Disease; Dysplasia Anus
• Intervention / Treatment: Diagnostic test: Anal pap smear and oral swab for cytology and HPV testing

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 384

Contacts and Locations

• Study Contact: Name: Antonio Giordano, MD; Phone Number: 0034 932919000; Email: dr.antoniogiordano@gmail.com

Study Locations

• Spain
  • Barcelona, Spain
    • Recruiting
    • Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    • Contact: Antonio Giordano, PhD; Email: inflamatoria@santpau.cat
    • Principal Investigator: Antonio Giordano, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; Anal and oral swab sampling for HPV detection (polymerase chain reaction) and cytology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 12 months

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Investigators: Principal Investigator: Antonio Giordano, MD, dr.antoniogiordano@gmail.com

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2023
• Primary Completion (Estimated): January 31, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: May 30, 2023
• First Submitted That Met QC Criteria: June 10, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Estimated): September 12, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: HPV, oral swab, anal swab
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Stomatognathic Diseases; Pathologic Processes; Disease Attributes; Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Tumor Virus Infections; Pathological Conditions, Signs and Symptoms; Papillomavirus Infections; Mouth Diseases; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytological Techniques
• Other Study ID Numbers: IIBSP-VHP-2023-47

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will be only shared upon request and with IEC approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No