Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2026-02-27 @ 4:09 PM
Study NCT ID:
NCT03172195
Status:
TERMINATED
Last Update Posted:
2025-06-05
First Post:
2017-05-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection of Herpesvirus DNA (CMV, EBV, HHV-6 and HSV) in Colonic Tissue: Impact on Ulcerative Colitis Flare-up
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D006561', 'term': 'Herpes Simplex'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011677', 'term': 'Punctures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'whyStopped': '* Lack of inclusion\n* Inability to open investigator centers due to lack of budget', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2017-05-23', 'studyFirstSubmitQcDate': '2017-05-29', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with different viral load in the colonic mucosa', 'timeFrame': 'day 1', 'description': 'Different viral loads are a composite outcome : viral load of CMV, EBV, HHV-6 and HSV.\n\nIt will be measured by Polymerase Chain Reaction technical in colonic mucosa'}], 'secondaryOutcomes': [{'measure': 'Correlation of the different viral loads with the Mayo endoscopic score', 'timeFrame': 'Day 1', 'description': 'Different viral loads are a composite outcome : viral load of CMV, EBV, HHV-6 and HSV.\n\nIt will be measured by Polymerase Chain Reaction technical in colonic mucosa The Mayo endoscopic score integrate the severity from lesions of colonic mucosa measured by rectosigmoidoscopy'}, {'measure': 'Correlation of the different viral loads with the steroid treatment response', 'timeFrame': 'up to 24 months', 'description': 'Different viral loads are a composite outcome : viral load of CMV, EBV, HHV-6 and HSV.\n\nIt will be measured by Polymerase Chain Reaction technical in colonic mucosa.\n\nSteroid treatment response is defined by clinic mayo score \\< 3 measured by rectosigmoidoscopy.'}, {'measure': 'Correlation of the different viral loads with the anti-TNF treatment response', 'timeFrame': 'up to 24 months', 'description': 'Different viral loads are a composite outcome : viral load of CMV, EBV, HHV-6 and HSV.\n\nIt will be measured by Polymerase Chain Reaction technical in colonic mucosa. anti-TNF treatment response is defined by clinic mayo score \\< 3 measured by rectosigmoidoscopy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ulcerative colitis', 'inflammation', 'immunosuppressive drugs', 'herpesvirus', 'qPCR', 'colonic mucosa'], 'conditions': ['Colitis, Ulcerative']}, 'descriptionModule': {'briefSummary': 'Flare-up of ulcerative colitis (UC) is characterized by the inflammation of colon mucosa that requires the use of immunosuppressive therapies. In previous studies, the active role of cytomegalovirus (CMV) has been demonstrated, with a correlation between the cytomegalovirus DNA ((deoxyribonucleic acid) load in the inflamed tissue and the resistance to successive lines of immunosuppressive therapy (Roblin et al., Am J Gastroenterol 2011). The main aim of this monocentric prospective study is to evaluate the DNA viral load by qPCR (Polymerase Chain Reaction) of 3 herpesviruses (Epstein-Barr virus, herpes virus 6 and herpes simplex) together with that of CMV in colonic mucosa depending of the local inflammation (endoscopically normal region, inflamed mucosa or ulcer) in patients suffering of moderate to severe UC flare-up (Mayo score \\>6 with endoscopic score higher or equal than 2). The viral load will also be correlated to the Mayo endoscopic score and the response to immunosuppressive drugs (steroid and anti-TNF (Tumor Necrosis Factor) monoclonal antibodies).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\>18 years\n* Voluntary to participate to the study\n* Flare-up of ulcerative colitis with Mayo score \\>6\n* Ability to receive steroid or anti-TNF therapy\n* Agree the rectosigmoidoscopy and the therapies\n\nExclusion Criteria:\n\n* Age \\<18 years\n* Pregnancy\n* Disagree the rectosigmoidoscopy or the therapies\n* Participation to the evaluation of a new therapy\n* Colectomy (partial or total)\n* Contraindication of steroid or anti-TNF therapy\n* Anticoagulant drugs'}, 'identificationModule': {'nctId': 'NCT03172195', 'acronym': 'VIRCH', 'briefTitle': 'Detection of Herpesvirus DNA (CMV, EBV, HHV-6 and HSV) in Colonic Tissue: Impact on Ulcerative Colitis Flare-up', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Saint Etienne'}, 'officialTitle': 'Detection of Herpesvirus DNA (CMV, EBV, HHV-6 and HSV) in Colonic Tissue: Impact on Ulcerative Colitis Flare-up', 'orgStudyIdInfo': {'id': '1708033'}, 'secondaryIdInfos': [{'id': 'ANSM', 'type': 'OTHER', 'domain': '2017-A00988-45'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with ulcerative colitis', 'description': 'Patients with ulcerative colitis will have a rectosigmoidoscopy, biopsies and blood sample.', 'interventionNames': ['Procedure: rectosigmoidoscopy', 'Biological: biopsies', 'Biological: blood sample']}], 'interventions': [{'name': 'rectosigmoidoscopy', 'type': 'PROCEDURE', 'description': 'A rectosigmoidoscopy will be realized and two fragments will be collected.', 'armGroupLabels': ['Patients with ulcerative colitis']}, {'name': 'biopsies', 'type': 'BIOLOGICAL', 'description': 'For this study, two biopsies in healthy area and two biopsies in ulcer will be collected.', 'armGroupLabels': ['Patients with ulcerative colitis']}, {'name': 'blood sample', 'type': 'BIOLOGICAL', 'description': 'Blood sample will be collected in more.', 'armGroupLabels': ['Patients with ulcerative colitis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '42055', 'city': 'Saint-Etienne', 'country': 'France', 'facility': 'CHU Saint-Etienne', 'geoPoint': {'lat': 45.43389, 'lon': 4.39}}], 'overallOfficials': [{'name': 'Xavier Roblin, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU SAINT-ETIENNE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Saint Etienne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}