Ignite Creation Date:
2025-12-24 @ 6:34 PM
Ignite Modification Date:
2026-04-25 @ 3:42 AM
Study NCT ID:
NCT02884557
Status:
COMPLETED
Last Update Posted:
2020-08-27
First Post:
2016-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NKT Role in the Regulation of the Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D015209', 'term': 'Cholangitis, Sclerosing'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D002761', 'term': 'Cholangitis'}, {'id': 'D001649', 'term': 'Bile Duct Diseases'}, {'id': 'D001660', 'term': 'Biliary Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-26', 'studyFirstSubmitDate': '2016-08-23', 'studyFirstSubmitQcDate': '2016-08-30', 'lastUpdatePostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The increase in the expression of the NKT marker Valpha24 mRNA by PCR in the colon of patients with PSC alone, PSC + IBD compared to patients with IBD alone', 'timeFrame': 'Through study completion, an average of 1 year'}], 'secondaryOutcomes': [{'measure': 'The number of NKT infiltrating colonic biopsies, using immunohistochemical staining', 'timeFrame': 'Through study completion, an average of 1 year'}, {'measure': 'The percentage of NKT cells among the peripheral blood lymphocytes by flow cytometry', 'timeFrame': 'At the time of the inclusion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Diseases', 'Primary Sclerosing Cholangitis']}, 'descriptionModule': {'briefSummary': "Inflammatory bowel diseases (IBD) include Crohn's disease (CD) and ulcerative colitis (UC). These diseases are a public health problem because they concern many patients (1 case in 1000). IBDs are characterized by dysregulated immune response against luminal antigens causing chronic inflammation of the gut in genetically predisposed individuals. Their exact cause is unknown and there is currently no cure. The primary sclerosing cholangitis (PSC) is a liver inflammatory disease of unknown origin that is known to be strongly associated with IBD. An important clinical observation highlights the mild symptoms of IBD when associated to the PSC. Conversely, treating PSC by liver transplant or immunosuppressive drugs is associated with a progression of intestinal inflammation.\n\nBased, on these clinical findings that suggest a protective effect regulator of liver inflammation on intestinal inflammation, and on the results obtained by our group in mouse models that identified the natural killer T cell (NKT) as essential in control of experimental colitis, the project aims to determine, using PCR, if the expression of NKT cell markers are increased in the colon of patients with PSC+IBD compared to patients with IBD alone or PSC alone."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with PSC alone, IBD alone or PSC + IBD\n* Obtention of oral and written consent\n* Patients affiliated with the social security system\n\nExclusion Criteria:\n\n* Minor patient\n* Suspicion of malignant lesion of the colon\n* Inability for information\n* person unable to consent, and not benefiting from a legal protection regimen\n* Person deprived of liberty'}, 'identificationModule': {'nctId': 'NCT02884557', 'acronym': 'NKT-CSP/MICI', 'briefTitle': 'NKT Role in the Regulation of the Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Lille'}, 'officialTitle': 'Evaluation of the Expression of Natural Killer T Cells (NKT) Marker in the Gut of Patients With Primary Sclerosing Cholangitis (PSC) Complicated by an Inflammatory Bowel Disease (IBD)', 'orgStudyIdInfo': {'id': '2011_06'}, 'secondaryIdInfos': [{'id': '2012-A00493-40', 'type': 'OTHER', 'domain': 'ID-RCB number, ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'PSC + IBD group', 'description': 'collection of gut biopsies collection of blood samples in patients with PSC and IBD', 'interventionNames': ['Other: collection of gut biopsies collection of blood samples']}, {'type': 'OTHER', 'label': 'IBD alone group', 'description': 'collection of gut biopsies collection of blood samples in patients with IBD alone', 'interventionNames': ['Other: collection of gut biopsies collection of blood samples']}], 'interventions': [{'name': 'collection of gut biopsies collection of blood samples', 'type': 'OTHER', 'description': 'Four to eight colon biopsies will be sampled during endoscopy. Thirty milliliters of blood will be sampled.', 'armGroupLabels': ['IBD alone group', 'PSC + IBD group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'country': 'France', 'facility': 'CHRU, Hôpital Claude Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Pierre Desreumeaux, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Lille'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Lille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}