Reactive Axillary Lymphadenopathy for SARS-CoV-2 Vaccines in the Asian Taiwanese PopulationNCT06429020
Sonography for COVID-19 Vaccines Related Reactive Lymphadenopathy
An observational study of Reactive Axillary Lymphadenopathy for SARS-CoV-2 Vaccines in the Asian Taiwanese Population, run by Chimei Medical Center at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Reactive Axillary Lymphadenopathy for SARS-CoV-2 Vaccines in the Asian Taiwanese Population
- What is being tested?
- the AstraZeneca ChAdOx1 (AZ) vaccine, Moderna mRNA-1273 (Moderna) vaccine, and Pfizer-BioNTech BNT162b2 (BNT) vaccine.
- Type of treatment
- Vaccines
- How many people
- 1,089 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2023to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- Women only
- Healthy volunteers accepted
- 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.
Who may be able to join
- female patients receiving breast sonography
Who cannot join
- receive Covid 19 vaccine other than AZ, BNT, Moderna
- Ongoing primary breast malignancy
- History of malignancy other than primary breast malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sonography for COVID-19 Vaccines Related Reactive Lymphadenopathy: A Retrospective Study
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.
Read the 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
- Reactive Axillary Lymphadenopathy for SARS-CoV-2 Vaccines in the Asian Taiwanese Population
- Being tested
- the AstraZeneca ChAdOx1 (AZ) vaccine, Moderna mRNA-1273 (Moderna) vaccine, and Pfizer-BioNTech BNT162b2 (BNT) vaccine.
- Keywords
- Breast Neoplasms, covid-19 vaccine, lymphadenopathy
- Medical subject headings
- Breast Neoplasms, Lymphadenopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the AstraZeneca ChAdOx1 (AZ) vaccine, Moderna mRNA-1273 (Moderna) vaccine, and Pfizer-BioNTech BNT162b2 (BNT) vaccine.Biological
record the condition of vaccination
| Study group | Role | What they receive |
|---|---|---|
| control group | non SARS-COV-2 vaccinated group | |
| vaccinated group | SARS-COV-2 vaccinated group Receives: Biological: the AstraZeneca ChAdOx1 (AZ) vaccine, Moderna mRNA-1273 (Moderna) vaccine, and Pfizer-BioNTech BNT162b2 (BNT) vaccine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presentation of axillary lymphadenopathy in sonographic examination
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2024
- Study start1 Jan 2023
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Reactive Axillary Lymphadenopathy for SARS-CoV-2 Vaccines in the Asian Taiwanese PopulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,089 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chimei Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pin Chi Huang, Study chair, ChiMei Medical Center, Taiwan, R.O.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06429020
- Sponsor's protocol ID
- CMMC11201-010
- Status last verified
- May 2024
- First submitted
- 13 May 2024
- Last updated
- 24 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sonography for COVID-19 Vaccines Related Reactive Lymphadenopathy: A Retrospective Study
- ClinicalTrials.gov ID
- NCT06429020
- Acronym / sponsor ID
- CMMC11201-010
- Conditions
- Reactive Axillary Lymphadenopathy for SARS-CoV-2 Vaccines in the Asian Taiwanese Population
- Keywords
- Breast Neoplasms, covid-19 vaccine, lymphadenopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,089 participants (actual)
- Lead sponsor
- Chimei Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 24 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | –non SARS-COV-2 vaccinated group |
| vaccinated group | – | Biological: the AstraZeneca ChAdOx1 (AZ) vaccine, Moderna mRNA-1273 (Moderna) vaccine, and Pfizer-BioNTech BNT162b2 (BNT) vaccine.SARS-COV-2 vaccinated group |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- female patients receiving breast sonography
Key exclusion criteria (3 listed)
- receive Covid 19 vaccine other than AZ, BNT, Moderna
- Ongoing primary breast malignancy
- History of malignancy other than primary breast malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the AstraZeneca ChAdOx1 (AZ) vaccine, Moderna mRNA-1273 (Moderna) vaccine, and Pfizer-BioNTech BNT162b2 (BNT) vaccine.record the condition of vaccination | Biological | vaccinated group |
Primary outcome
Presentation of axillary lymphadenopathy in sonographic examination
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pin Chi Huang study chair
ChiMei Medical Center, Taiwan, R.O.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Reactive Axillary Lymphadenopathy for SARS-CoV-2 Vaccines in the Asian Taiwanese Population, run by Chimei Medical Center at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presentation of axillary lymphadenopathy in sonographic examination (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2024.