Breast CancerNCT07188116
Correlation Between COVID-19 and Radiation Pneumonitis in Breast Cancer
An observational study of Breast Cancer and Radiation Pneumonia, run by Zhejiang Hospital at 1 site in China.
Trial summary
This study was designed as a single-center retrospective analysis aimed at investigating whether COVID-19 infection increases the risk or burden of radiation-induced pneumonitis in breast cancer patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Radiation Pneumonia, COVID-19
- What is being tested?
- COVID-19
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Breast cancer patients who underwent radiotherapy at the Cancer Center of Zhejiang Hospital between January 1, 2021, and June 30, 2024, were screened for eligibility.
Who may be able to join
- patients with pathologically or cytologically confirmed primary breast cancer,
- aged 18 years or older but younger than 80 years,
- with complete and reliable medical records,
- for those with COVID-19 infection, documented evidence of a positive test result.
Who cannot join
- concomitant pulmonary malignancies,
- a history of prior thoracic radiotherapy,
- concurrent pulmonary infections other than COVID-19 during radiotherapy,
- missing key data with loss to follow-up,
- or any other condition considered unsuitable for enrollment by the investigators.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhejiang Hospital, Department of Oncology, Hangzhou, China, 310030
Hangzhou, Zhejiang, 310030
Pengyuan Liu, 18368846455, oncologyliupengyuan@outlook.com
About this study
Official title: Correlation Between COVID-19 and Radiation Pneumonitis in Breast Cancer: A Historical Cohort Study
This study was designed as a single-center retrospective analysis aimed at investigating whether COVID-19 infection increases the risk or burden of radiation-induced pneumonitis in breast cancer patients.
Read the detailed description
This study was designed as a single-center retrospective analysis aimed at investigating whether COVID-19 infection increases the risk or burden of radiation-induced pneumonitis in breast cancer patients. Breast cancer patients who underwent radiotherapy at the Cancer Center of Zhejiang Hospital between January 1, 2021, and June 30, 2024, were screened for eligibility. Patients who met the inclusion criteria were identified through the hospital information system, and their clinical records were reviewed. Follow-up was conducted via telephone interviews.
- Conditions
- Breast Cancer, Radiation Pneumonia, COVID-19
- Being tested
- COVID-19
- Keywords
- Retrospective Analysis, COVID-19, Radiation Pneumonitis, Propensity Score Matching, Breast Cancer
- Medical subject headings
- Breast Neoplasms, Radiation Pneumonitis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
COVID-19Other
The COVID-19 infection situation was used as an intervention measure, and the cohort was divided into groups.
| Study group | Role | What they receive |
|---|---|---|
| Without COVID-19 | No COVID-19 infection Receives: Other: COVID-19 | |
| With COVID-19 | With COVID-19 infection Receives: Other: COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiation Pneumonitis Situation
The incidence rate, severity and onset time of radiation pneumonitis
Measured: From January 2021 to June 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07188116
- Sponsor's protocol ID
- COBRA-001
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 23 Sep 2025
- 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 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between COVID-19 and Radiation Pneumonitis in Breast Cancer: A Historical Cohort Study
- ClinicalTrials.gov ID
- NCT07188116
- Acronym / sponsor ID
- COBRA-001
- Conditions
- Breast Cancer, Radiation Pneumonia, COVID-19
- Keywords
- Retrospective Analysis, COVID-19, Radiation Pneumonitis, Propensity Score Matching, Breast Cancer
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhejiang HospitalUniversity, hospital or other
- Study start
- 15 Sep 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Sep 2025 (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 was designed as a single-center retrospective analysis aimed at investigating whether COVID-19 infection increases the risk or burden of radiation-induced pneumonitis in breast cancer patients.
Detailed description
This study was designed as a single-center retrospective analysis aimed at investigating whether COVID-19 infection increases the risk or burden of radiation-induced pneumonitis in breast cancer patients. Breast cancer patients who underwent radiotherapy at the Cancer Center of Zhejiang Hospital between January 1, 2021, and June 30, 2024, were screened for eligibility. Patients who met the inclusion criteria were identified through the hospital information system, and their clinical records were reviewed. Follow-up was conducted via telephone interviews.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without COVID-19 | – | Other: COVID-19No COVID-19 infection |
| With COVID-19 | – | Other: COVID-19With COVID-19 infection |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Breast cancer patients who underwent radiotherapy at the Cancer Center of Zhejiang Hospital between January 1, 2021, and June 30, 2024, were screened for eligibility.
Key inclusion criteria (4 listed)
- patients with pathologically or cytologically confirmed primary breast cancer,
- aged 18 years or older but younger than 80 years,
- with complete and reliable medical records,
- for those with COVID-19 infection, documented evidence of a positive test result.
Key exclusion criteria (5 listed)
- concomitant pulmonary malignancies,
- a history of prior thoracic radiotherapy,
- concurrent pulmonary infections other than COVID-19 during radiotherapy,
- missing key data with loss to follow-up,
- or any other condition considered unsuitable for enrollment by the investigators.
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 |
|---|---|---|
| COVID-19The COVID-19 infection situation was used as an intervention measure, and the cohort was divided into groups. | Other | With COVID-19, Without COVID-19 |
Primary outcome
Radiation Pneumonitis Situation
Time frame: From January 2021 to June 2024
The incidence rate, severity and onset time of radiation pneumonitis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No
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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.
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 Breast Cancer and Radiation Pneumonia, run by Zhejiang Hospital at 1 site in China.
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 4 inclusion and 5 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: opening soon, as of the sponsor's last update on 23 Sep 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pengyuan Liu (18368846455, oncologyliupengyuan@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiation Pneumonitis Situation (time frame: From January 2021 to June 2024). 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 23 Sep 2025.