NCT06429020

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,089

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 24, 2024

Completed
Last Updated

May 24, 2024

Status Verified

May 1, 2024

Enrollment Period

12 months

First QC Date

May 13, 2024

Last Update Submit

May 20, 2024

Conditions

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

Keywords

Breast Neoplasmscovid-19 vaccinelymphadenopathy

Outcome Measures

Primary Outcomes (1)

  • Presentation of axillary lymphadenopathy in sonographic examination

    through study completion, an average of 1 year

Study Arms (2)

control group

non SARS-COV-2 vaccinated group

vaccinated group

SARS-COV-2 vaccinated group

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

Interventions

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

record the condition of vaccination

vaccinated group

Eligibility Criteria

Age20 Years - 80 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • female patients receiving breast sonography

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ChiMei Medical Center

Tainan, 710402, Taiwan

Location

MeSH Terms

Conditions

Breast NeoplasmsLymphadenopathy

Interventions

Vaccines

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Biological ProductsComplex Mixtures

Study Officials

  • Pin Chi Huang

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

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2024

First Posted

May 24, 2024

Study Start

January 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

May 24, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)