Ignite Creation Date:
2025-12-24 @ 4:50 PM
Ignite Modification Date:
2025-12-29 @ 1:19 PM
Study NCT ID:
NCT05911750
Status:
RECRUITING
Last Update Posted:
2025-09-12
First Post:
2023-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence and Clinical Implications of HPV Infection in Male IBD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D030361', 'term': 'Papillomavirus Infections'}, {'id': 'D009059', 'term': 'Mouth Diseases'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003584', 'term': 'Cytological Techniques'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Rectal and oral mucosal cells collected by anal and oral swab, respectively.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 384}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2023-05-30', 'studyFirstSubmitQcDate': '2023-06-10', 'lastUpdatePostDateStruct': {'date': '2025-09-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence (number/percentage) of HPV infection in oral and anal samples', 'timeFrame': 'Up to 12 months', 'description': 'PCR analysis will identify the presence of HPV in oral or anal mucosal cells and characterize the genotype of HPV.'}, {'measure': 'Prevalence (number/percentage) of abnormal HPV-related cytology in oral and anal samples', 'timeFrame': 'Up to 12 months', 'description': 'Cytology changes will be reported according to the Bethesda classification.'}], 'secondaryOutcomes': [{'measure': 'Multivariate analysis to identify risk factors for HPV infection in oral and anal samples.', 'timeFrame': 'Up to 12 months', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HPV, oral swab, anal swab'], 'conditions': ['HPV Infection', 'Dysplasia Anus', 'Oral Cavity Disease']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAccording to local practice, patients with anal or oral squamous intraepithelial lesions (ASIL) will be referred to a colorectal surgeon for further recommendations or treatment.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Male IBD patients referring to the IBD Clinic of Hospital de la Santa Creu i Sant Pau', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosed Crohn's disease or ulcerative colitis (at least 3 months before enrollment)\n* Male\n* Age from 18 to 79 years\n\nExclusion Criteria:\n\n* Unclassified Inflammatory Bowel Disease\n* Diarrhea (\\> 3 bowel movements/day) with rectal bleeding at enrollment\n* Prior full proctectomy\n* Inability to collect the biological samples\n* Inability to complete the questionnaire\n* Refusal to sign the informed consent"}, 'identificationModule': {'nctId': 'NCT05911750', 'acronym': 'PAPIMALE', 'briefTitle': 'Prevalence and Clinical Implications of HPV Infection in Male IBD Patients', 'organization': {'class': 'OTHER', 'fullName': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau"}, 'officialTitle': 'Prevalence and Clinical Implications of Human Papillomavirus Infection in the Male Population With Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': 'IIBSP-VHP-2023-47'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Male IBD patients', 'description': 'Male patients with a confirmed diagnosis of Inflammatory Bowel Disease (Crohn´s disease or Ulcerative colitis).', 'interventionNames': ['Diagnostic Test: Anal pap smear and oral swab for cytology and HPV testing']}], 'interventions': [{'name': 'Anal pap smear and oral swab for cytology and HPV testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Anal and oral swab sampling for HPV detection (polymerase chain reaction) and cytology', 'armGroupLabels': ['Male IBD patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Antonio Giordano, PhD', 'role': 'CONTACT', 'email': 'inflamatoria@santpau.cat'}, {'name': 'Antonio Giordano, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Antonio Giordano, MD', 'role': 'CONTACT', 'email': 'dr.antoniogiordano@gmail.com', 'phone': '0034 932919000'}], 'overallOfficials': [{'name': 'Antonio Giordano, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'dr.antoniogiordano@gmail.com'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will be only shared upon request and with IEC approval.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}