Prevalence and Clinical Implications of HPV Infection in Male IBD Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

384 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-12

Study Completion Date

2026-06-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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HPV Infection Dysplasia Anus Oral Cavity Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Male IBD patients

Male patients with a confirmed diagnosis of Inflammatory Bowel Disease (Crohn´s disease or Ulcerative colitis).

Anal pap smear and oral swab for cytology and HPV testing

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Anal pap smear and oral swab for cytology and HPV testing

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No