Dysplasia Anus, HPV Infection, Oral Cavity Disease
Conditions
Keywords
HPV, oral swab, anal swab
Brief 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.
Interventions
DIAGNOSTIC_TESTAnal pap smear and oral swab for cytology and HPV testing
Anal and oral swab sampling for HPV detection (polymerase chain reaction) and cytology
Sponsors
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
MALE
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence (number/percentage) of HPV infection in oral and anal samples | Up to 12 months | PCR analysis will identify the presence of HPV in oral or anal mucosal cells and characterize the genotype of HPV. |
| Prevalence (number/percentage) of abnormal HPV-related cytology in oral and anal samples | Up to 12 months | Cytology changes will be reported according to the Bethesda classification. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Multivariate analysis to identify risk factors for HPV infection in oral and anal samples. | 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 |
Countries
Spain
Contacts
Primary ContactAntonio Giordano, MD
Outcome results
None listed