Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2026-02-20 @ 10:56 PM
Study NCT ID:
NCT03778918
Status:
UNKNOWN
Last Update Posted:
2020-03-03
First Post:
2018-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Comparison Between the Biomarkers in Inflammatory Bowel Disease Patients and General Control Group
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D003092', 'term': 'Colitis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood, Biopsy tissue, Stool'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'targetDuration': '36 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-02', 'studyFirstSubmitDate': '2018-12-09', 'studyFirstSubmitQcDate': '2018-12-16', 'lastUpdatePostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measurement of blood-based biomarkers to predict disease activity 1', 'timeFrame': 'within 12 weeks of the blood sampling', 'description': 'REG3 alpha (ng/mL)'}, {'measure': 'measurement of blood-based biomarkers to predict disease activity 2', 'timeFrame': 'within 12 weeks of the blood sampling', 'description': 'hs-CRP (mg/dL)'}, {'measure': 'measurement of blood-based biomarkers to predict disease activity 3', 'timeFrame': 'within 12 weeks of the blood sampling', 'description': 'serum calprotectin (ng/mL)'}], 'secondaryOutcomes': [{'measure': 'Age (years)', 'timeFrame': 'at the time of study enrolled', 'description': 'age at the time of study enrolled'}, {'measure': 'Gender (M/F)', 'timeFrame': 'at the time of study enrolled', 'description': 'male of female'}, {'measure': 'disease duration (months)', 'timeFrame': 'at the time of study enrolled', 'description': 'duration of disease'}, {'measure': 'disease onset (years)', 'timeFrame': 'at the time of study enrolled', 'description': 'age at which the disease begins'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['REG3 alpha', 'IBD', 'biomarker', 'ulcerative colitis', 'serum calprotectin'], 'conditions': ['Inflammatory Bowel Diseases', 'Irritable Bowel Syndrome']}, 'referencesModule': {'references': [{'pmid': '29133078', 'type': 'BACKGROUND', 'citation': 'Darnaud M, Dos Santos A, Gonzalez P, Augui S, Lacoste C, Desterke C, De Hertogh G, Valentino E, Braun E, Zheng J, Boisgard R, Neut C, Dubuquoy L, Chiappini F, Samuel D, Lepage P, Guerrieri F, Dore J, Brechot C, Moniaux N, Faivre J. Enteric Delivery of Regenerating Family Member 3 alpha Alters the Intestinal Microbiota and Controls Inflammation in Mice With Colitis. Gastroenterology. 2018 Mar;154(4):1009-1023.e14. doi: 10.1053/j.gastro.2017.11.003. Epub 2017 Nov 11.'}, {'pmid': '26278889', 'type': 'BACKGROUND', 'citation': "Greuter T, Lang S, Holler E, Hawkey CJ, Rogler G, Biedermann L; ASTIC trial group. Serum REG3alpha and C-Reactive Protein Levels in Crohn's Disease Patients Undergoing Immunoablation and Autologous Hemopoetic Stem Cell Transplantation in the ASTIC Trial. Digestion. 2015;92(2):83-9. doi: 10.1159/000437300. Epub 2015 Aug 1."}, {'pmid': '23200544', 'type': 'BACKGROUND', 'citation': 'Harris AC, Levine JE, Ferrara JL. Have we made progress in the treatment of GVHD? Best Pract Res Clin Haematol. 2012 Dec;25(4):473-8. doi: 10.1016/j.beha.2012.10.010. Epub 2012 Oct 25.'}]}, 'descriptionModule': {'briefSummary': "The aims of this study is to investigate a blood-based biomarker that can replace endoscopy in patients with inflammatory bowel disease. For this purpose, blood sample of patients wiht inflammatory bowel disease (ulcerative colitis, Crohn 's disease) was collected at the same time the endoscopy is performed, stored after centrifugation, and analyzed accordingly. Selected biomarkers from the blood sample were investigated to compare those of patients with inflammatory bowel disease and those of general controls. Males and females over the age of 19 participated in the study and are excluded if they have chronic kidney disease or blood clotting disease. The outcome is a find of a blood-based biomarker that best reflects a disease activity.", 'detailedDescription': "Inflammatory bowel disease refers to chronic inflammation of the unknown origin that occurs in the intestine. It usually refers to ulcerative colitis and Crohn's disease, which are idiopathic inflammatory bowel diseases. While it had been known to be a common disease in the western world, in recent decades the incidence of ulcerative colitis and Crohn's disease has rapidly increased in Korea as well. Endoscopic examination is a gold standard in order to determine the activity of inflammatory bowel disease, but it is hardly performed due to the cost and time of a test. Therefore, it is necessary to find a blood-based biomarker that replaces endoscopy. The objective of the study is to identify a new inflammatory marker that replaces endoscopy by comparing blood samples of patients with inflammatory bowel disease with those of general controls."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "inflammatory bowel disease (ulcerative colitis, Crohn's Dz.) irritable bowel syndrome normal control", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* people who receive colonoscopy\n* people who sign the consent\n* having inflammatory bowel disease (ulcerative colitis, Crohn's Dz.) and irritable bowel syndrome\n\nExclusion Criteria:\n\n* those aged over 75 years\n* the disabled\n* pregnant women\n* chronic renal diseases (CLcr \\<50ml/min)\n* blood coagulopathy (PT INR \\> 1.5, aPTT \\> 45 seconds, or platelet count \\< 50,000/mm)\n* people who refuse to sign the consent"}, 'identificationModule': {'nctId': 'NCT03778918', 'briefTitle': 'The Comparison Between the Biomarkers in Inflammatory Bowel Disease Patients and General Control Group', 'organization': {'class': 'OTHER', 'fullName': "Seoul St. Mary's Hospital"}, 'officialTitle': 'The Comparison Between That Expression Pattern and Disease Activity of Variable Biomarkers in Inflammatory Bowel Disease Patients and General Control Group. Multicenter, Prospective Study', 'orgStudyIdInfo': {'id': 'XC18TEDI0027'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'inflammatory bowel disease', 'description': "inflammatory bowel disease such as Ulcerative colitis and Crohn's disease", 'interventionNames': ['Other: inflammatory bowel disease', 'Other: IBS or Normal Control']}, {'label': 'IBS or Normal Control', 'description': 'irritable bowel syndrome patients normal patients', 'interventionNames': ['Other: inflammatory bowel disease', 'Other: IBS or Normal Control']}], 'interventions': [{'name': 'inflammatory bowel disease', 'type': 'OTHER', 'description': 'blood based biomarkers in IBD such as REG3 alpha, serum calprotectin and hs-CRP', 'armGroupLabels': ['IBS or Normal Control', 'inflammatory bowel disease']}, {'name': 'IBS or Normal Control', 'type': 'OTHER', 'description': 'blood based biomarker compared normal control with IBD', 'armGroupLabels': ['IBS or Normal Control', 'inflammatory bowel disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '137-701', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Bo-In Lee, MD, PhD', 'role': 'CONTACT', 'email': 'gidoc4u@gmail.com', 'phone': '82-10-8367-1055'}, {'name': 'Bo-In Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Division of Gastroenterology; Seoul St. Mary's hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Bo-In Lee, MD. Ph.D.', 'role': 'CONTACT', 'email': 'gidoc4u@gmail.com', 'phone': '82-10-8367-1055'}, {'name': 'Seungjun Kim, MD.', 'role': 'CONTACT', 'email': 'gmt475@gmail.com', 'phone': '82-10-8786-2799'}], 'overallOfficials': [{'name': 'Bo-In Lee, MD. Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Seoul St. Mary's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bo-In Lee', 'class': 'OTHER'}, 'collaborators': [{'name': "Incheon St.Mary's Hospital", 'class': 'OTHER'}, {'name': "St Vincent's Hospital", 'class': 'OTHER'}, {'name': "Daejeon St. Mary's hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, MD, PhD.', 'investigatorFullName': 'Bo-In Lee', 'investigatorAffiliation': "Seoul St. Mary's Hospital"}}}}