Prevalence and Clinical Implications of HPV Infection in Male IBD Patients (PAPIMALE)

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

Status: Enrolling

Conditions: HPV Infection; Oral Cavity Disease; Dysplasia Anus

Treatments: Diagnostic Test: Anal pap smear and oral swab for cytology and HPV testing

Study type: Observational

Funder types: Other

Identifiers

NCT05911750

IIBSP-VHP-2023-47

Details and patient eligibility

About

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.

Full 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.

Enrollment: 384 estimated patients

Sex: Male

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

384 participants in 1 patient group

Male IBD patients

Description:

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

Treatment:

Diagnostic Test: Anal pap smear and oral swab for cytology and HPV testing