Sonography for COVID-19 Vaccines Related Reactive Lymphadenopathy

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.

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Key information

Conditions

Reactive Axillary Lymphadenopathy for SARS-CoV-2 Vaccines in the Asian Taiwanese Population Breast Diseases Breast Neoplasms Hemic and Lymphatic Diseases Lymphadenopathy Lymphatic Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

20 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

ChiMei Medical Center

Tainan, 710402, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

female patients receiving breast sonography

Exclusion criteria

receive Covid 19 vaccine other than AZ, BNT, Moderna
Ongoing primary breast malignancy
History of malignancy other than primary breast malignancy

Treatment and study plan

the AstraZeneca ChAdOx1 (AZ) vaccine, Moderna mRNA-1273 (Moderna) vaccine, and Pfizer-BioNTech BNT162b2 (BNT) vaccine.

Biological

record the condition of vaccination

Primary outcomes

Presentation of axillary lymphadenopathy in sonographic examination

Time frame: through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

Chimei Medical Center

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: May 24, 2024
Registry last updated: May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed