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临床试验/NCT06429020
NCT06429020已完成不适用

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

Chimei Medical Center1 个研究点 分布在 1 个国家目标入组 1,089 人开始时间: 2023年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,089
试验地点
1
主要终点
Presentation of axillary lymphadenopathy in sonographic examination

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • female patients receiving breast sonography

排除标准

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

结局指标

主要结局

Presentation of axillary lymphadenopathy in sonographic examination

时间窗: through study completion, an average of 1 year

次要结局

未报告次要终点

研究者

发起方
Chimei Medical Center
申办方类型
Other
责任方
Sponsor

研究点 (1)

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