Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:04 AM
Study NCT ID:
NCT03760094
Status:
UNKNOWN
Last Update Posted:
2018-11-30
First Post:
2018-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Color Doppler Ultrasound in Lymphadenopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-29', 'studyFirstSubmitDate': '2018-11-29', 'studyFirstSubmitQcDate': '2018-11-29', 'lastUpdatePostDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of patients with benign lymphadenopathy', 'timeFrame': 'one year', 'description': 'comparison with the biopsy result'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lymph Node Disease']}, 'descriptionModule': {'briefSummary': 'Lymphadenopathy is defined as an abnormality in the size or character of lymph nodes caused by the invasion or propagation of either inflammatory or neoplastic cells into the nodes Accurate lymph node characterization is important for a wide number of clinical situations, including prognosis, prediction, selecting and monitoring treatment, beyond the diagnosis itself (cancer, lymphoma, or inflammatory nodes)', 'detailedDescription': 'Various ultrasound criteria that can help in differentiation of benign and malignant lymph nodes have been well described in literature. On Gray scale ultrasound imaging, the benign enlarged lymph nodes are hypoechoic, oval shaped with smooth border and echogenic hilum. On the other hand, the malignant lymph nodes are round with short to long axis ratio \\>0.5 and show loss of echogenic hilum, while the Color and Power Doppler features documented for the diagnosis of malignant lymph nodes are peripheral and mixed vascularity, with resistive index (RI) more than 0.8, and pulsatility index (PI) more than 1.5 Although Color Doppler ultrasound improves diagnostic accuracy and plays an important adjuvant role to Gray scale ultrasound in differentiating benign from malignant lymph nodes as it adds to the diagnostic confidence of predicting malignancy in enlarged lymph nodes, and also is useful if Gray scale ultrasound findings are equivocal. However, it can neither replace histopathology nor can eliminate the need for biopsy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinically enlarged lymph nodes\n\nExclusion Criteria:\n\n* previous medical treatment or radiotherapy\n* previous biopsy'}, 'identificationModule': {'nctId': 'NCT03760094', 'briefTitle': 'Role of Color Doppler Ultrasound in Lymphadenopathy', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Role of Color Doppler Ultrasound in Differentiation Between Benign and Malignant Lymphadenopathy', 'orgStudyIdInfo': {'id': 'Color Doppler Ultrasound'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'patients with lymphadenopathy', 'interventionNames': ['Device: Colour Doppler']}], 'interventions': [{'name': 'Colour Doppler', 'type': 'DEVICE', 'description': 'evaluation of lymph nodes by Doppler', 'armGroupLabels': ['Study group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Mina Gergis Naeem', 'investigatorAffiliation': 'Assiut University'}}}}