Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Male IBD patients | Male patients with a confirmed diagnosis of Inflammatory Bowel Disease (Crohn´s disease or Ulcerative colitis). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anal pap smear and oral swab for cytology and HPV testing | Diagnostic Test | Anal and oral swab sampling for HPV detection (polymerase chain reaction) and cytology |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence (number/percentage) of HPV infection in oral and anal samples | PCR analysis will identify the presence of HPV in oral or anal mucosal cells and characterize the genotype of HPV. | Up to 12 months |
| Prevalence (number/percentage) of abnormal HPV-related cytology in oral and anal samples | Cytology changes will be reported according to the Bethesda classification. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Multivariate analysis to identify risk factors for HPV infection in oral and anal samples. | 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 | Up to 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Male IBD patients referring to the IBD Clinic of Hospital de la Santa Creu i Sant Pau
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antonio Giordano, MD | Contact | 0034 932919000 | dr.antoniogiordano@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Antonio Giordano, MD | dr.antoniogiordano@gmail.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Recruiting | Barcelona | Spain |
IPD will be only shared upon request and with IEC approval.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D030361 | Papillomavirus Infections |
| D009059 | Mouth Diseases |
| ID | Term |
|---|---|
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D007239 | Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D003584 | Cytological Techniques |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Rectal and oral mucosal cells collected by anal and oral swab, respectively.
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D014412 | Tumor Virus Infections |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009057 | Stomatognathic Diseases |