Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-31 @ 12:59 PM
Study NCT ID:
NCT01521104
Status:
COMPLETED
Last Update Posted:
2012-01-30
First Post:
2012-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Value of Narrow Band Imaging in Stratifying Patients for Endoscopic Resection or Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': "All the lesions will be removed endoscopically or surgically and examined histologically by an independent gastrointestinal pathologist.\n\nHistological diagnosis is determined according to the World Health Organization (WHO) criteria.Pedunculated lesions are categorized according to Haggitt's classification."}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 565}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-27', 'studyFirstSubmitDate': '2012-01-25', 'studyFirstSubmitQcDate': '2012-01-27', 'lastUpdatePostDateStruct': {'date': '2012-01-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['narrow band imaging（NBI）', 'colorectal lesions', 'predicting histology'], 'conditions': ['Colorectal Neoplasms']}, 'descriptionModule': {'briefSummary': 'Magnification narrow band imaging (NBI) can make accurate evaluation in in predicting of invasive depth of colorectal neoplasia.', 'detailedDescription': 'NBI could be used in stratifying patients for endoscopic resection or surgery and got an accurate evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'consecutive adult patients undergo colonoscopy and find out more than one lesion ≧ 6mm from Jan 2009 to Dec 2010', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consecutive patients with more than one lesion ≧6mm\n\nExclusion Criteria:\n\n* Patients with chronic inflammatory bowel disease,\n* advanced cancer,\n* insufficient bowel preparation,\n* familial adenomatous polyposis (FAP)\n* Lesions ≦ 5mm and submucosal tumor (SMT).'}, 'identificationModule': {'nctId': 'NCT01521104', 'briefTitle': 'The Value of Narrow Band Imaging in Stratifying Patients for Endoscopic Resection or Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'The Value of NBI in Stratifying Patients for Endoscopic Resection or Surgery', 'orgStudyIdInfo': {'id': 'rjxhnk02'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Shanghai Institute of Digestive Disease，Renji Hospital, Shanghai Jiao Tong University School of Medicine', 'investigatorFullName': 'Xiaobo Li', 'investigatorAffiliation': 'Shanghai Jiao Tong University School of Medicine'}}}}