Ignite Creation Date:
2025-12-25 @ 4:28 AM
Ignite Modification Date:
2026-01-17 @ 3:56 AM
Study NCT ID:
NCT06429020
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2024-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sonography for COVID-19 Vaccines Related Reactive Lymphadenopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D000072281', 'term': 'Lymphadenopathy'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014612', 'term': 'Vaccines'}], 'ancestors': [{'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1089}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-20', 'studyFirstSubmitDate': '2024-05-13', 'studyFirstSubmitQcDate': '2024-05-20', 'lastUpdatePostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presentation of axillary lymphadenopathy in sonographic examination', 'timeFrame': 'through study completion, an average of 1 year'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Breast Neoplasms', 'covid-19 vaccine', 'lymphadenopathy'], 'conditions': ['Reactive Axillary Lymphadenopathy for SARS-CoV-2 Vaccines in the Asian Taiwanese Population']}, 'descriptionModule': {'briefSummary': 'This study aimed to provide vast clinical information to facilitate breast sonographic examination for participants who underwent recent SARS-CoV-2 vaccination.\n\nAmong different SARS-CoV-2 vaccines in the Asian Taiwanese population, reactive axillary lymphadenopathy was investigated through breast sonographic findings and clinical data analysis. The sample included participants with recent vaccinations by different brands approved in Taiwan.', 'detailedDescription': "Study Design and Sample The retrospective study included female patients who underwent breast sonography in the radiology department of Chi Mei Medical Center between July 2021 and March 2022. The patients' breast cancer history and COVID-19 vaccination history were collected and analyzed.\n\nAnalysis of Breast Sonography Lymphadenopathy is defined as an enlarged lymph node with cortical thickening \\>3 mm, either concentric or eccentric, with or without effacement of fatty hilum, or in-creased non-hilar vascularity on color or power Doppler. The positive axillary lymph node findings were correlated by confirming a link to SARS-CoV-2 vaccination history within 90 days in the ipsilateral arm.\n\nStatistical Analysis All statistical analyses were performed using the R Stats package. Descriptive summaries were reported as mean ± standard deviation for continuous variables and percentages for categorical variables. For non-parametric variables, median with interquartile range and Mann-Whitney U test were used. Statistical significance was set at a p-value \\<0.05."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent breast sonography in the radiology department of Chi Mei Medical Center between July 2021 and March 2022.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female patients receiving breast sonography\n\nExclusion Criteria:\n\n* receive Covid 19 vaccine other than AZ, BNT, Moderna\n* Ongoing primary breast malignancy\n* History of malignancy other than primary breast malignancy'}, 'identificationModule': {'nctId': 'NCT06429020', 'briefTitle': 'Sonography for COVID-19 Vaccines Related Reactive Lymphadenopathy', 'organization': {'class': 'OTHER', 'fullName': 'Chimei Medical Center'}, 'officialTitle': 'Sonography for COVID-19 Vaccines Related Reactive Lymphadenopathy: A Retrospective Study', 'orgStudyIdInfo': {'id': 'CMMC11201-010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'control group', 'description': 'non SARS-COV-2 vaccinated group'}, {'label': 'vaccinated group', 'description': 'SARS-COV-2 vaccinated group', 'interventionNames': ['Biological: the AstraZeneca ChAdOx1 (AZ) vaccine, Moderna mRNA-1273 (Moderna) vaccine, and Pfizer-BioNTech BNT162b2 (BNT) vaccine.']}], 'interventions': [{'name': 'the AstraZeneca ChAdOx1 (AZ) vaccine, Moderna mRNA-1273 (Moderna) vaccine, and Pfizer-BioNTech BNT162b2 (BNT) vaccine.', 'type': 'BIOLOGICAL', 'description': 'record the condition of vaccination', 'armGroupLabels': ['vaccinated group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '710402', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'ChiMei Medical Center', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'overallOfficials': [{'name': 'Pin Chi Huang', 'role': 'STUDY_CHAIR', 'affiliation': 'ChiMei Medical Center, Taiwan, R.O.C.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chimei Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}