Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06429020
Status:
COMPLETED
Last Update Posted:
2024-05-24
First Post:
2024-05-13
Brief Title:
Sonography for COVID-19 Vaccines Related Reactive Lymphadenopathy
Sponsor:
Chimei Medical Center
Organization:
Chimei Medical Center
Study Overview
Official Title:
Sonography for COVID-19 Vaccines Related Reactive Lymphadenopathy A Retrospective Study
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aimed to provide vast clinical information to facilitate breast sonographic examination for participants who underwent recent SARS-CoV-2 vaccination
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
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
Detailed Description:
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
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 005
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 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None