Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-03-11 @ 1:30 PM
Study NCT ID:
NCT02772406
Status:
UNKNOWN
Last Update Posted:
2016-05-13
First Post:
2016-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Linked Color Imaging vs. White Light for Colorectal Dysplasia in Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-05-12', 'studyFirstSubmitDate': '2016-05-12', 'studyFirstSubmitQcDate': '2016-05-12', 'lastUpdatePostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The number of Colorectal Dysplasia detected by LCI', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'The endoscopic scores with LCI', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ulcerative colitis', 'colonoscopy', 'Dysplasia', 'Diagnosis'], 'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '25952309', 'type': 'RESULT', 'citation': 'Leifeld L, Rogler G, Stallmach A, Schmidt C, Zuber-Jerger I, Hartmann F, Plauth M, Drabik A, Hofstadter F, Dienes HP, Kruis W; Detect Dysplasia Study Group. White-Light or Narrow-Band Imaging Colonoscopy in Surveillance of Ulcerative Colitis: A Prospective Multicenter Study. Clin Gastroenterol Hepatol. 2015 Oct;13(10):1776-1781.e1. doi: 10.1016/j.cgh.2015.04.172. Epub 2015 May 5.'}], 'seeAlsoLinks': [{'url': 'https://www.ncbi.nlm.nih.gov/pubmed/25952309', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether a new colonoscopic viewing technique called Linked color imaging(LCI) helps endoscopists detect more dysplasia lesions in ulcerative colitis patients than conventional colonoscopy using white light alone.', 'detailedDescription': 'Patients with longstanding IBD have increased risk of colorectal cancer (CRC) compared to the general population. The association between duration of the disease and development of CRC is the rationale for endoscopic surveillance. Colonoscopic surveillance of ulcerative colitis patients has been shown to reduce the risk of colorectal cancer and allow detection at an earlier stage, but even with meticulous examination, some precancerous lesions or cancers are missed. The newly developed LCI system (FUJIFILM Co.) creates clear and bright endoscopic images by using short-wavelength narrow-band laser light combined with white laser light on the basis of BLI technology. LCI makes red areas appear redder and white areas appear whiter. Thus, it is easier to recognize a slight difference in color of the mucosa. This is a study to determine if using Linked color imaging (LCI) of the colon, rather than the usual white light on the colon, will improve the detection of more dysplasia lesions in ulcerative colitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:patients with ulcerative colitis who meet surveillance criteria Exclusion Criteria:pregnant patients,unable or unwilling to give informed consent,patients with severe active colitis who would be unsafe to endoscope'}, 'identificationModule': {'nctId': 'NCT02772406', 'briefTitle': 'Linked Color Imaging vs. White Light for Colorectal Dysplasia in Ulcerative Colitis', 'organization': {'class': 'OTHER', 'fullName': 'Affiliated Hospital to Academy of Military Medical Sciences'}, 'officialTitle': 'Linked Color Imaging (LCI) Versus White Light for the Detection of Colorectal Dysplasia in Ulcerative Colitis', 'orgStudyIdInfo': {'id': '307-LCI-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group', 'description': '(With LCI endoscopy and 1 month later with white light endoscopy) The patients will be evaluated by Linked Color Imaging and 1 month later evaluated by White Light endoscopy', 'interventionNames': ['Device: Linked Color Imaging']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': '(With white light endoscopy and 1 month later with LCI endoscopy) The patients will be evaluated by White Light endoscopy and 1 month later evaluated by Linked Color Imaging', 'interventionNames': ['Device: white light imaging']}], 'interventions': [{'name': 'Linked Color Imaging', 'type': 'DEVICE', 'armGroupLabels': ['Experimental group']}, {'name': 'white light imaging', 'type': 'DEVICE', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Min Min, M.D.,Ph.D.', 'role': 'CONTACT', 'email': 'minmin823@sina.com', 'phone': '+86-010-66947473'}], 'facility': 'Affiliated Hospital to Academy of Military Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Min Min, M.D.,Ph.D.', 'role': 'CONTACT', 'email': 'minmin823@sina.com', 'phone': '+86-010-66947473'}, {'name': 'Xiaotian Sun, M.D.,Ph.D.', 'role': 'CONTACT', 'email': 'xiaotian-sun@hotmail.com', 'phone': '+86-010-66947473'}], 'overallOfficials': [{'name': 'Yan Liu, M.D.,Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Affiliated Hospital to Academy of Military Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Affiliated Hospital to Academy of Military Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}