Prevalence and Clinical Implications of HPV Infection in Male IBD Patients

Trial Title: Prevalence and Clinical Implications of HPV Infection in Male IBD Patients

NCT ID: NCT05911750

Condition: HPV Infection
Dysplasia Anus
Oral Cavity Disease

Conditions: Official terms:
Infections
Communicable Diseases
Papillomavirus Infections
Mouth Diseases

Conditions: Keywords:
HPV, oral swab, anal swab

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Cross-Sectional

Intervention:

Intervention type: Diagnostic Test
Intervention name: Anal pap smear and oral swab for cytology and HPV testing
Description: Anal and oral swab sampling for HPV detection (polymerase chain reaction) and cytology
Arm group label: Male IBD patients

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.

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.

Criteria for eligibility:

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

Sampling method: Probability Sample
Criteria:
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

Gender: Male

Minimum age: 18 Years

Maximum age: 79 Years

Healthy volunteers: No

Locations:

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

Address:
City: Barcelona
Country: Spain

Status: Recruiting

Contact:
Last name: Antonio Giordano, PhD
Email: inflamatoria@santpau.cat

Investigator:
Last name: Antonio Giordano, PhD
Email: Principal Investigator

Start date: February 12, 2023

Completion date: June 1, 2025

Lead sponsor:
Agency: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Agency class: Other

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

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05911750