Ignite Creation Date:
2025-12-25 @ 4:33 AM
Ignite Modification Date:
2026-02-20 @ 11:56 PM
Study NCT ID:
NCT01909518
Status:
UNKNOWN
Last Update Posted:
2013-07-26
First Post:
2013-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection of Early Esophageal Squamous Neoplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'endoscopic biopsies will be taken at suspicious lesions'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-07-24', 'studyFirstSubmitDate': '2013-07-24', 'studyFirstSubmitQcDate': '2013-07-24', 'lastUpdatePostDateStruct': {'date': '2013-07-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The diagnostic accuracy of pCLE on early esophageal squamous neoplasia', 'timeFrame': '6 month', 'description': 'Patients will be prospectively recruited to evaluate the diagnostic sensitivity, specificity and accuracy of early esophageal squamous neoplasia by using probe-based confocal laser endomicroscopy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Esophageal Squamous Intraepithelial Neoplasia', 'surface maturation scoring', 'probe-based confocal laser endomicroscopy', 'virtual chromoendoscopy'], 'conditions': ['Esophageal Squamous Intraepithelial Neoplasia']}, 'descriptionModule': {'briefSummary': 'The aim of the present study：\n\n1. To investigate the diagnosing value of pCLE for early esophageal squamous neoplasia.\n2. To assess the detection rate of early esophageal squamous neoplasia by virtual chromoendoscopy', 'detailedDescription': "Probe-based confocal laser endomicroscopy (pCLE; Cellvizio, Mauna Kea Technologies, Paris, France) is a newly developed endoscopic device and has shown its value for diagnosing Barrett's esophagus, colonal polyps and etc. However, none research has focus on early esophageal squamous neoplasia until now. Previous diagnosis of early esophageal neoplasia is based on the lugol staining which is time wasting and have many adverse events.Other researches have suggested virtual chromoendoscopys are beneficial for screening esophageal tumors. Therefore, the aim of the present study is 1.To investigate the diagnosing value of pCLE for early esophageal squamous neoplasia according to the surface maturation scoring(SMS) diagnostic criteria and 2. To assess the detection rate of early esophageal squamous neoplasia by virtual chromoendoscopy(I-SCAN)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients screened that fulfill the eligibility criteria at Qilu Hospital, Shandong University will be enrolled into the study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 50 and 80 years old\n* Patients undergo screening endoscopy or histologically verified esophageal squamous intraepithelial neoplasia before.\n\nExclusion Criteria:\n\n* Advanced esophageal, gastric or duodenal cancer\n* History of upper GI tract surgery\n* Coagulopathy or acute GI bleeding\n* Pregnant or breast-feeding (for females)\n* Impaired renal function\n* Allergy to fluorescein sodium\n* Inability to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT01909518', 'briefTitle': 'Detection of Early Esophageal Squamous Neoplasia', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'Detection of Early Esophageal Squamous Neoplasia by Using Virtual Chromoendoscopy and Probe-based Confocal Laser Endomicroscopy', 'orgStudyIdInfo': {'id': '2013SDU-QILU-G02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pCLE examination', 'description': 'pCLE is used to distinguish the suspected lesions detected by I-SCAN in esophagus'}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanqing Li, MD. PhD.', 'role': 'CONTACT', 'email': 'liyanqing@sdu.edu.cn', 'phone': '86-531-82169236', 'phoneExt': '82169508'}], 'facility': 'Department of Gastroenterology, Qilu Hospital, Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Yangqing Li, PhD. MD', 'role': 'CONTACT', 'email': 'liyanqing@sdu.edu.cn', 'phone': '86-531-82169236', 'phoneExt': '82169508'}], 'overallOfficials': [{'name': 'Yanqing Li, MD. PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qilu Hospital, Shandong University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice president of Qilu Hospital', 'investigatorFullName': 'Yanqing Li', 'investigatorAffiliation': 'Shandong University'}}}}