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Spots Global Cancer Trial Database for Sonography for COVID-19 Vaccines Related Reactive Lymphadenopathy

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Trial Identification

Brief Title: Sonography for COVID-19 Vaccines Related Reactive Lymphadenopathy

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

Study ID: NCT06429020

Study Description

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.

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.

Eligibility

Minimum Age: 20 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: FEMALE

Healthy Volunteers: Yes

Locations

ChiMei Medical Center, Tainan City, , Taiwan

Contact Details

Name: Pin Chi Huang

Affiliation: ChiMei Medical Center, Taiwan, R.O.C.

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

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