Ignite Creation Date:
2025-12-24 @ 4:03 PM
Ignite Modification Date:
2025-12-24 @ 4:03 PM
Study NCT ID:
NCT02939066
Status:
UNKNOWN
Last Update Posted:
2017-02-16
First Post:
2016-10-18
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Endoscopic Ultrasound-guided Needle-based Confocal Laser Endomicroscopy for Evaluation of Malignant Lymph Nodes - a Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'lastUpdateSubmitDate': '2017-02-14', 'studyFirstSubmitDate': '2016-10-18', 'studyFirstSubmitQcDate': '2016-10-18', 'lastUpdatePostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The nCLE interpretation criteria for the characterization of malignant lymph nodes', 'timeFrame': '20 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Malignancy or Benign of Enlarged Lymph Nodes']}, 'descriptionModule': {'briefSummary': 'Current modalities for lymph node staging in cancer can be limited. Needle-based confocal laser endomicroscopy (nCLE) is a novel endoscopic technique, which is compatible with the 19-gauge FNA needle. Under endoscopic ultrasonography (EUS) guidance, nCLE enables real-time in vivo imaging of lesion tissues at cellular and subcellular levels.This study aimed to evaluate the feasibility of needle-based confocal laser endomicroscopy (nCLE) at the time of endoscopic ultrasound (EUS) and to describe the nCLE features that distinguish between benign and malignant lymph nodes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The patients undergoing EUS for staging of malignancy or assessment of enlarged lymph nodes will be recruited in this study at Qilu Hospital, Shandong University.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing EUS for staging of malignancy or assessment of enlarged lymph nodes\n\nExclusion Criteria:\n\n* Patients aged \\<18 years or \\>80 years\n* Known allergy to fluorescein dye\n* Previous EUS-FNA performed within the past 3 months, and usualcontraindications to EUS-FNA\n* Pregnancy or breastfeeding\n* Inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT02939066', 'briefTitle': 'Endoscopic Ultrasound-guided Needle-based Confocal Laser Endomicroscopy for Evaluation of Malignant Lymph Nodes - a Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'orgStudyIdInfo': {'id': '2016SDU-QILU-22'}}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yanqing Li, PhD. MD.', 'role': 'CONTACT', 'email': 'liyanqing@sdu.edu.cn', 'phone': '18678827666'}], 'facility': 'Department of Gastroenterology, Qilu Hospital, Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Yanqing Li, PhD. MD.', 'role': 'CONTACT', 'email': 'liyanqing@sdu.edu.cn', 'phone': '18678827666'}], 'overallOfficials': [{'name': 'Yanqing Li, PhD. MD.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Gastroenterology, 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'}}}}