Prevalence and Clinical Implications of HPV Infection in Male IBD Patients

HPV Infection Clinical Trial

— PAPIMALE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05911750
• Other study ID #: IIBSP-VHP-2023-47
• Status: Recruiting
• Start date: February 12, 2023
• Est. completion date: June 1, 2025

Study information

• Verified date: June 2023
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: Antonio Giordano, MD
• Phone: 0034 932919000
• Email: dr.antoniogiordano[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 384
• Est. completion date: June 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• HPV Infection
• Infections
• Mouth Diseases
• Oral Cavity Disease
• Papillomavirus Infections

Intervention

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

Locations

Country	Name	City	State
Spain	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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