Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT05151458
Status:
UNKNOWN
Last Update Posted:
2021-12-14
First Post:
2021-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Serum NGAL as a Predictor of Clinical and Endoscopic Activity of Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-12-29', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-12', 'studyFirstSubmitDate': '2021-11-29', 'studyFirstSubmitQcDate': '2021-11-29', 'lastUpdatePostDateStruct': {'date': '2021-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'test the sensitivity and specificity of using NGAL in diagnosis of IBD', 'timeFrame': 'One year', 'description': 'test the sensitivity and specificity of using NGAL in diagnosis of IBD'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Diseases']}, 'referencesModule': {'references': [{'pmid': '22200942', 'type': 'BACKGROUND', 'citation': 'Oikonomou KA, Kapsoritakis AN, Theodoridou C, Karangelis D, Germenis A, Stefanidis I, Potamianos SP. Neutrophil gelatinase-associated lipocalin (NGAL) in inflammatory bowel disease: association with pathophysiology of inflammation, established markers, and disease activity. J Gastroenterol. 2012 May;47(5):519-30. doi: 10.1007/s00535-011-0516-5. Epub 2011 Dec 27.'}, {'pmid': '31361991', 'type': 'BACKGROUND', 'citation': 'Nakov R. New markers in ulcerative colitis. Clin Chim Acta. 2019 Oct;497:141-146. doi: 10.1016/j.cca.2019.07.033. Epub 2019 Jul 27.'}]}, 'descriptionModule': {'briefSummary': 'Ulcerative colitis (UC) and Crohns disease (CD) represent the two major forms of inflammatory bowel disease (IBD), characterized by epithelial cell damage and prominent mucosal infiltration by inflammatory cells including granulocytes, macrophages, lymphocytes, and plasma cells.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults with IBD', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria: IBD patients diagnosed by endoscopy.\n\nMale and female gender. Disease activity proven clinically and endoscopy . Assiut university hospital patients\n\nExclusion Criteria:\n\n* Patients who refuse to contribute in this study Pregnancy and breast feeding Cancer patients Renal pathology Diabetes Mellitus Cardiovascular patients Pancreatitis COPD patients'}, 'identificationModule': {'nctId': 'NCT05151458', 'briefTitle': 'Serum NGAL as a Predictor of Clinical and Endoscopic Activity of Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Serum NGAL as a Predictor of Clinical and Endoscopic Activity of Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': 'NGAL in IBD'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohamed Alsadek Ma Ghozaly, Master', 'role': 'CONTACT', 'email': 'alsadekmohamed215@gmail.com', 'phone': '01150993206'}, {'name': 'Hossam Ma Abd Alwahab', 'role': 'CONTACT', 'phone': '01146539976'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Serum NGAL as a predictor of clinical and endoscopic activity of inflammatory bowel disease', 'investigatorFullName': 'Mohamed Alsadek Mahmoud Ghozaly', 'investigatorAffiliation': 'Assiut University'}}}}