NCT06429020

Sonography for COVID-19 Vaccines Related Reactive Lymphadenopathy

Sonography for COVID-19 Vaccines Related Reactive Lymphadenopathy: A Retrospective Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,089 (actual)
• Sponsor: Chimei Medical Center · Academic / Other
• Sex: Female
• Age: 20 Years – 80 Years
• Healthy volunteers: Accepted

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.

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 \<0.05.

Conditions

• Reactive Axillary Lymphadenopathy for SARS-CoV-2 Vaccines in the Asian Taiwanese Population

Interventions

Type	Name	Description
BIOLOGICAL	the AstraZeneca ChAdOx1 (AZ) vaccine, Moderna mRNA-1273 (Moderna) vaccine, and Pfizer-BioNTech BNT162b2 (BNT) vaccine.	record the condition of vaccination

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2024-05-24
• Last updated: 2024-05-24

Locations

1 site across 1 country: Taiwan