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NCT Number: NCT05911750

Prevalence and Clinical Implications of HPV Infection in Male IBD Patients

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.

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Key information

Conditions

HPV Infection Communicable Diseases DNA Virus Infections Disease Attributes Dysplasia Anus Genital Diseases Infections Mouth Diseases Oral Cavity Disease Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Stomatognathic Diseases Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

18 year–79 year

Sex eligibility

Male

Study type

Observational

Primary location

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

Barcelona, Spain

Location status: Recruiting

Location contact

Antonio Giordano, PhD

CONTACT

[email protected]

Antonio Giordano, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Prevalence (number/percentage) of HPV infection in oral and anal samples

    Time frame: Up to 12 months

    PCR analysis will identify the presence of HPV in oral or anal mucosal cells and characterize the genotype of HPV.

  2. Prevalence (number/percentage) of abnormal HPV-related cytology in oral and anal samples

    Time frame: Up to 12 months

    Cytology changes will be reported according to the Bethesda classification.

Secondary outcomes

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

    Time frame: Up to 12 months

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Giordano, MD

CONTACT

[email protected]

0034 932919000

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: PAPIMALE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2023
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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