Sonography for COVID-19 Vaccines Related Reactive Lymphadenopathy
NCT ID: NCT06429020
Last Updated: 2024-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1089 participants
OBSERVATIONAL
2023-01-01
2023-12-31
Brief Summary
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Among 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.
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Detailed Description
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Analysis 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.
Statistical 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.
Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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control group
non SARS-COV-2 vaccinated group
No interventions assigned to this group
vaccinated group
SARS-COV-2 vaccinated group
the AstraZeneca ChAdOx1 (AZ) vaccine, Moderna mRNA-1273 (Moderna) vaccine, and Pfizer-BioNTech BNT162b2 (BNT) vaccine.
record the condition of vaccination
Interventions
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the AstraZeneca ChAdOx1 (AZ) vaccine, Moderna mRNA-1273 (Moderna) vaccine, and Pfizer-BioNTech BNT162b2 (BNT) vaccine.
record the condition of vaccination
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Ongoing primary breast malignancy
* History of malignancy other than primary breast malignancy
20 Years
80 Years
FEMALE
Yes
Sponsors
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Chimei Medical Center
OTHER
Responsible Party
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Principal Investigators
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Pin Chi Huang
Role: STUDY_CHAIR
ChiMei Medical Center, Taiwan, R.O.C.
Locations
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ChiMei Medical Center
Tainan City, , Taiwan
Countries
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Other Identifiers
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CMMC11201-010
Identifier Type: -
Identifier Source: org_study_id
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