Prevalence and Clinical Implications of HPV Infection in Male IBD Patients

Last updated: February 14, 2024
Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Anal pap smear and oral swab for cytology and HPV testing

Clinical Study ID

NCT05911750
IIBSP-VHP-2023-47
  • Ages 18-79
  • Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 Design

Total Participants: 384
Treatment Group(s): 1
Primary Treatment: Anal pap smear and oral swab for cytology and HPV testing
Phase:
Study Start date:
February 12, 2023
Estimated Completion Date:
June 01, 2025

Study 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.

Connect with a study center

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

    Barcelona,
    Spain

    Active - Recruiting

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