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

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05911750
• Collaborator: (none)
• Enrollment: 384
• Location: 1
• Anticipated Duration (Months): 18
• Patients Per Site Per Month: 21.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
HPV Infection; Dysplasia Anus; Oral Cavity Disease	Diagnostic Test: Anal pap smear and oral swab for cytology and HPV testing

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 384 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Prevalence and Clinical Implications of Human Papillomavirus Infection in the Male Population With Inflammatory Bowel Disease
• Anticipated Study Start Date: Dec 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Male IBD patients Male patients with a confirmed diagnosis of Inflammatory Bowel Disease (Crohn´s disease or Ulcerative colitis).	Diagnostic Test: Anal pap smear and oral swab for cytology and HPV testing; Anal and oral swab sampling for HPV detection (polymerase chain reaction) and cytology

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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 Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 79 Years
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Barcelona		Spain

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Antonio Giordano, MD, [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• ClinicalTrials.gov Identifier: NCT05911750
• Other Study ID Numbers: IIBSP-VHP-2023-47
• First Posted: Jun 22, 2023
• Last Update Posted: Jun 28, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: HPV, oral swab, anal swab
• Additional relevant MeSH terms: Infections; Communicable Diseases; Papillomavirus Infections; Mouth Diseases

Study Results

No Results Posted as of Jun 28, 2023