Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 12:56 AM
Study NCT ID:
NCT04928560
Status:
UNKNOWN
Last Update Posted:
2021-06-16
First Post:
2021-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnosis of Superficial Lymphadenopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072281', 'term': 'Lymphadenopathy'}], 'ancestors': [{'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-09', 'studyFirstSubmitDate': '2021-04-07', 'studyFirstSubmitQcDate': '2021-06-09', 'lastUpdatePostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PATHOLOGY', 'timeFrame': 'up to 3 months', 'description': 'BIOPSY/SURGERY'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymphadenopathy', 'ULTRASOUND']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to study the application of CEUS and SMI technology in superficial lymph node lesions (metastasis, lymphoma, inflammation, etc.), and to provide some diagnostic ideas for non-invasive diagnosis of lymph node lesions.', 'detailedDescription': 'CEUS and SMI technology were used to evaluated the superficial lymph node lesions (metastasis, lymphoma, inflammation, etc.), and to provide some diagnostic ideas for non-invasive diagnosis of lymph node lesions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with lymphadenopathy', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥ 18 years old and ≤ 80 years old;\n2. Patients with enlarged lymph nodes detected by ultrasound;\n3. No contraindications such as hypersensitivity to contrast-enhanced ultrasound;\n4. Voluntarily enrolled in this research project\n\nExclusion Criteria:\n\n* The patient's position cannot be matched during ultrasound examination\n\n * Treatment history of lesion area: operation, radiotherapy, intervention, etc ③ Patients without informed consent ④ Lack of clinical data (no effective images such as two-dimensional ultrasound, color Doppler, contrast-enhanced ultrasound, micro blood flow imaging, or poor image quality, unable to analyze, unknown pathological results, etc.) ⑤ Lack of follow up information"}, 'identificationModule': {'nctId': 'NCT04928560', 'briefTitle': 'Diagnosis of Superficial Lymphadenopathy', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'SMI and CEUS in the Diagnosis of Superficial Lymphadenopathy', 'orgStudyIdInfo': {'id': '2020-588'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'disease free survival', 'description': 'disease free survival', 'interventionNames': ['Diagnostic Test: SMI']}, {'label': 'non-disease free survival', 'description': 'non-disease free survival', 'interventionNames': ['Diagnostic Test: SMI']}], 'interventions': [{'name': 'SMI', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['CEUS'], 'description': 'ULTRASOUND', 'armGroupLabels': ['disease free survival', 'non-disease free survival']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'ZJU', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'pintong Huang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}