## Protocol Section
### Identification Module
**NCT ID:** NCT06429020

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

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

#### Organization Study ID Info
**ID:** CMMC11201-010
#### Organization
**Class:** OTHER
**Full Name:** Chimei Medical Center
### Status Module
#### Completion Date
**Date:** 2023-12-31

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-20

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2023-12-31

**Type:** ACTUAL

#### Start Date
**Date:** 2023-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-13
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Chimei Medical Center

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

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

**Keywords:**

- Breast Neoplasms

- covid-19 vaccine

- lymphadenopathy

### Design Module

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 1089

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** non SARS-COV-2 vaccinated group

**Label:** control group

#### Arm Group 2

**Description:** SARS-COV-2 vaccinated group

**Intervention Names:**

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

**Label:** vaccinated group

### Interventions

#### Intervention 1

**Arm Group Labels:**

- vaccinated group

**Description:** record the condition of vaccination

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

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Measure:** Presentation of axillary lymphadenopathy in sonographic examination

**Time Frame:** through study completion, an average of 1 year

### Eligibility Module

**Eligibility Criteria:** 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

**Healthy Volunteers:** True

**Maximum Age:** 80 Years

**Minimum Age:** 20 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients who underwent breast sonography in the radiology department of Chi Mei Medical Center between July 2021 and March 2022.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tainan City

**Country:** Taiwan

**Facility:** ChiMei Medical Center

**Zip:** 710402

#### Overall Officials

**Official 1:**

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

**Name:** Pin Chi Huang

**Role:** STUDY_CHAIR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000011024

- Term: Pneumonia, Viral

- ID: D000011014

- Term: Pneumonia

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000018352

- Term: Coronavirus Infections

- ID: D000003333

- Term: Coronaviridae Infections

- ID: D000030341

- Term: Nidovirales Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000008206

- Term: Lymphatic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC15

- Name: Blood and Lymph Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M2561

- Name: COVID-19

- Relevance: HIGH

- As Found: COVID-19

- ID: M994

- Name: Lymphadenopathy

- Relevance: HIGH

- As Found: Lymphadenopathy

- ID: M13904

- Name: Pneumonia

- Relevance: LOW

- As Found: Unknown

- ID: M13914

- Name: Pneumonia, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M20490

- Name: Coronavirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6555

- Name: Coronaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M23685

- Name: Nidovirales Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11203

- Name: Lymphatic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000086382

- Term: COVID-19

- ID: D000072281

- Term: Lymphadenopathy

### Intervention Browse Module - Ancestors

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M17360

- Name: Vaccines

- Relevance: HIGH

- As Found: Other

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000014612

- Term: Vaccines

### Misc Info Module

- Version Holder: 2024-05-31
