Ignite Creation Date:
2025-12-24 @ 1:38 PM
Ignite Modification Date:
2026-01-06 @ 6:44 AM
Study NCT ID:
NCT02878395
Status:
UNKNOWN
Last Update Posted:
2016-08-25
First Post:
2016-08-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genomic/Epigenomic Biomarkers of Deregulation of Immune System in Inflammatory Bowel Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Ileocolic resection with last loops of small intestine, colon portion and corresponding mesenteric-colic fat.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-22', 'studyFirstSubmitDate': '2016-08-22', 'studyFirstSubmitQcDate': '2016-08-22', 'lastUpdatePostDateStruct': {'date': '2016-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Gene expression profile in intestinal operative specimens', 'timeFrame': 'up to 2 months (from resection)'}, {'measure': 'Methylation profile in intestinal operative specimens', 'timeFrame': 'up to 2 months (from resection)'}], 'secondaryOutcomes': [{'measure': 'Digestive symptoms', 'timeFrame': '6, 12, 24 months (after resection)', 'description': 'such as abdominal pain, Koenig syndrome (abdominal pain relieved by flatus or feces expulsion), diarrhea'}, {'measure': 'Radiological classification of recurrence with entero-MRI performed for post-operating follow-up of patients', 'timeFrame': '6, 12, 24 months (after resection)', 'description': 'Koilakou score, recurrence when score \\>=1'}, {'measure': 'Evaluation of recurrence with endoscopy performed for post-operating follow-up of patients', 'timeFrame': '6, 12, 24 months (after resection)', 'description': 'Rutgeerts criteria (recurrence when score \\>=i1)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['genomics', 'epigenomics', 'recurrence'], 'conditions': ['Crohn Disease']}, 'descriptionModule': {'briefSummary': "The purpose is to search for enterocyte-specific or non-specific molecular signature of post-operating recurrence of Crohn's disease in transcriptome (measurement of gene expression through number of mRNA copies transcribed for each gene) and in methylome.\n\nSecondary objectives are to compare expression and methylation profiles according to:\n\n* treatment response\n* morphological (endoscopic and/or radiological) and clinical post-operating recurrence.", 'detailedDescription': 'This aim of this study is to search for new biomarkers predictive of post-operating recurrence.\n\nAt present, there are no biomarkers predictive for post-operating recurrence and administration of a post-operating medical treatment to prevent recurrence is based on biological, endoscopic and imagery data.\n\nPredictive biomarkers could allow the identification of patients with high risk of post-operating recurrence and administration of a systematic prophylactic post-operating treatment and at the same time avoiding the prescription of this treatment to patients with low risk of post-operating recurrence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with Crohn's disease needing an ileocolic resection at CHRU Nancy.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with inflammatory bowel disease diagnosis based on clinical (abdominal pain, diarrhea and/or dysenteric syndrome, mostly muco-hemorrhagic, perianal injury, with sometimes general signs and /or systemic manifestations ), biological (inflammatory syndrome, deficiencies…), radiological (entero-MRI), endoscopic (presence of granulomatous lesions) and/or histological (epithelioid and giant cellular granuloma) data\n* Patient undergoing ileocolic resection\n* Patient affiliated to French social security\n\nExclusion Criteria:\n\n* Patient refusing sampling\n* Patient with undetermined colitis\n* Patient with non-confirmed diagnosis of inflammatory bowel disease\n* Patient with inflammatory bowel disease not undergoing ileocolic resection'}, 'identificationModule': {'nctId': 'NCT02878395', 'acronym': 'PREDIPOSTOP', 'briefTitle': 'Genomic/Epigenomic Biomarkers of Deregulation of Immune System in Inflammatory Bowel Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': "Genomic/Epigenomic Biomarkers of Deregulation of Immune System in Inflammatory Bowel Diseases: Prediction of Post-operating Natural History of Crohn's Disease", 'orgStudyIdInfo': {'id': 'PJC 2014/MICI-GERMAIN/MS'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Crohn's disease", 'interventionNames': ['Procedure: Ileocolic resection']}], 'interventions': [{'name': 'Ileocolic resection', 'type': 'PROCEDURE', 'armGroupLabels': ["Crohn's disease"]}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Adeline GERMAIN', 'role': 'CONTACT', 'email': 'a.germain@chru-nancy.fr'}], 'overallOfficials': [{'name': 'Adeline GERMAIN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Service de Chirurgie Digestive, Hépatobiliaire, Endocrinienne et Cancérologique CHRU Nancy Brabois Adultes'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}