Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2026-01-24 @ 10:33 PM
Study NCT ID:
NCT02003859
Status:
COMPLETED
Last Update Posted:
2014-11-19
First Post:
2013-11-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictive Value of pCLE Findings in Pediatric IBD
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': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Optical biopsy'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-18', 'studyFirstSubmitDate': '2013-11-30', 'studyFirstSubmitQcDate': '2013-12-05', 'lastUpdatePostDateStruct': {'date': '2014-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary study end-point was moderate to severe flare requiring hospitalization after pCLE', 'timeFrame': 'follow up period was a median of 18 months (range 4 to 33)', 'description': 'The purpose of the current study is to determine the predictive value of pCLE findings in pediatric IBD patients.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IBD', 'Pediatrics', 'pCLE'], 'conditions': ['Inflammatory Bowel Disease']}, 'referencesModule': {'references': [{'pmid': '26513619', 'type': 'DERIVED', 'citation': 'Shavrov A, Kharitonova AY, Davis EM, Claggett B, Morozov DA, Brown DK, Shavrov AA, Liu JJ. A Pilot Study of Confocal Laser Endomicroscopy to Predict Barrier Dysfunction and Relapse in Pediatric Inflammatory Bowel Disease. J Pediatr Gastroenterol Nutr. 2016 Jun;62(6):873-8. doi: 10.1097/MPG.0000000000001022.'}]}, 'descriptionModule': {'briefSummary': 'Studies over the past two decades have convincingly demonstrated the role of barrier dysfunction in the pathogenesis of inflammatory bowel disease. It previously shown that optical biopsy with probe-based confocal laser endomicroscopy (pCLE) could be used to assess mucosal barrier function. Furthermore, mucosal barrier dysfunction on pCLE was shown to be predictive of disease relapse in adult IBD patients. The purpose of the current study is to determine the predictive value of pCLE findings in pediatric IBD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '10 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Pediatric patients with IBD from all over Russia, treated from IBD in our Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signed informed consent\n* patients with established IBD\n\nExclusion Criteria:\n\n* Any kind of allergy\n* Bronchial asthma\n* Liver or kidney disease\n* Inability to sign informed consent'}, 'identificationModule': {'nctId': 'NCT02003859', 'briefTitle': 'Predictive Value of pCLE Findings in Pediatric IBD', 'organization': {'class': 'OTHER', 'fullName': "Scientific Center of Children's Health RAMS"}, 'officialTitle': 'Predictive Value of pCLE Findings in Pediatric IBD', 'orgStudyIdInfo': {'id': 'SCCH-001'}}, 'contactsLocationsModule': {'locations': [{'zip': '119991', 'city': 'Moscow', 'country': 'Russia', 'facility': "The Scientific Center of Children's Health", 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Andrey A Shavrov, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': "The Scientififc Center of Children's Health"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Scientific Center of Children's Health RAMS", 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Alberta', 'class': 'OTHER'}, {'name': 'Harvard Medical School (HMS and HSDM)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Anton A. Shavrov', 'investigatorAffiliation': "Scientific Center of Children's Health RAMS"}}}}