Breast CancerNCT06319209
Timing of Surgery and the Evolution of Postoperative Outcomes in Breast Cancer Patients Undergoing Surgical Intervention Following Recovery From SARS-CoV-2 Infection
An observational study of Breast Cancer and COVID-19, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
Perioperative SARS-CoV-2 infection significantly increases the risk of postoperative complications and mortality, while also exerting long-lasting impacts on multiple organs and systems. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer, COVID-19, Postoperative Complications
- What is being tested?
- Preoperative resolved COVID-19
- How many people
- 392 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 31 Mar 2024
- How long will I take part?
- 12 Months
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The first group was the resolved COVID-19 group, which served as the experimental group and included patients who had recovered from SARS-CoV-2 infection between January 2023 and March 2023 and underwent limited breast cancer operations in our Breast Surgery Department. These patients had a history of SARS-CoV-2 infection before surgery. The second group was the pre-COVID-19 group, which served as the control group and included patients who underwent limited breast cancer operations in our Breast Surgery Department between June and August 2022 and had no history of SARS-CoV-2 infection before surgery. However, these patients were diagnosed with COVID-19 after the first tumor assessment after surgery (at least 90 days after surgery) and excluded patients who had been infected with SARS-CoV-2 within 90 days after surgery or showed distant metastases.
Who may be able to join
- Breast cancer patients who underwent surgery after recovering from SARS-CoV-2 infection
- Breast cancer patients who had never been infected with SARS-CoV-2 before surgery
Who cannot join
- Distant metastasis
- Pregnancy-associated breast cancer
- Incomplete follow-up information
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Timing of Surgery and the Evolution of Postoperative Outcomes in Breast Cancer Patients Undergoing Surgical Intervention Following Recovery From SARS-CoV-2 Infection: a Matched, Longitudinal, Prospective Cohort Study
Perioperative SARS-CoV-2 infection significantly increases the risk of postoperative complications and mortality, while also exerting long-lasting impacts on multiple organs and systems. Due to the curtailment or cessation of non-emergency surgeries during the initial phase of the pandemic, there is a lack of evidence regarding the optimal timing and medium- to long-term postoperative outcomes of surgical intervention in breast cancer patients with prior SARS-CoV-2 infection, particularly after vaccination. We aim to investigate whether prior SARS-CoV-2 infection increases the risk of postoperative adverse outcomes in breast cancer patients and determine the optimal timing for surgical intervention during the pandemic, as well as to longitudinally assess the evolution of postoperative adverse outcomes within one year after COVID-19 and identify associated risk factors.
Read the detailed description
This study employs a prospective cohort design with longitudinal and matched characteristics, focusing on breast cancer patients who underwent surgery after recovering from SARS-CoV-2 infection. Patients were stratified by the time of surgery relative to COVID-19 diagnosis. The Inverse Probability of Treatment Weighting (IPTW) method was used to match a control group (COVID-19 negative) based on patient, tumor, and surgical factors in order to compare composite indicators (including death, pneumonia, thrombosis, cardiac complications, and unplanned hospitalization) for evaluating the optimal timing of surgery. We investigated the longitudinal evolution of postoperative adverse outcomes and identified the relevant risk factors through logistic regression analysis.
- Conditions
- Breast Cancer, COVID-19, Postoperative Complications
- Being tested
- Preoperative resolved COVID-19
- Medical subject headings
- Breast Neoplasms, COVID-19, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative resolved COVID-19Other
We observed postoperative outcomes only in patients who had or did not have COVID-19 before surgery, without any additional intervention.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative resolved COVID-19 | Patients who had a history of SARS-CoV-2 infection prior to surgery underwent limited breast cancer operations in the Breast Surgery Department of our hospital after recovering from SARS-CoV-2 infection between January 2023 and March 2023. Receives: Other: Preoperative resolved COVID-19 | |
| Preoperative COVID-19 negative | Patients undergoing limited surgery for breast cancer in our Breast Surgery Department between June and August 2022 had no history of SARS-CoV-2 infection prior to surgery. However, they were diagnosed with COVID-19 after the first tumor evaluation following surgery, which occurred at least 90 days after the surgery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day postoperative outcomes
Composite indicators (including death, pneumonia, thrombosis, cardiac complications, and unplanned hospitalization) of COVID-19-related adverse outcomes within 30 days after surgery
Measured: Within 30 days after surgery
Secondary outcomes (2)
Postoperative outcomes at the time of the initial tumor assessment after surgery
Composite indicators (including death, pneumonia, thrombosis, cardiac complications, and unplanned hospitalization) of COVID-19-related adverse outcomes at the time of the initial tumor assessment after surgery
Measured: The time of the initial tumor assessment after surgery (about 90 days after surgery)
12-month postoperative outcomes
Composite indicators (including death, pneumonia, thrombosis, cardiac complications, and unplanned hospitalization) of COVID-19-related adverse outcomes at 12 months after surgery
Measured: Within 12 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start1 Jan 2023
- Primary completion31 Mar 2023
- Study completion31 Mar 2024 (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.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 392 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chuan Wang, Fujian Medical University Union Hospital
- Investigators
- Chuan Wang, Study chair, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319209
- Sponsor's protocol ID
- 2024KY023
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 19 Mar 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 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing of Surgery and the Evolution of Postoperative Outcomes in Breast Cancer Patients Undergoing Surgical Intervention Following Recovery From SARS-CoV-2 Infection: a Matched, Longitudinal, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06319209
- Acronym / sponsor ID
- 2024KY023
- Conditions
- Breast Cancer, COVID-19, Postoperative Complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 392 participants (actual)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 19 Mar 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.
Perioperative SARS-CoV-2 infection significantly increases the risk of postoperative complications and mortality, while also exerting long-lasting impacts on multiple organs and systems. Due to the curtailment or cessation of non-emergency surgeries during the initial phase of the pandemic, there is a lack of evidence regarding the optimal timing and medium- to long-term postoperative outcomes of surgical intervention in breast cancer patients with prior SARS-CoV-2 infection, particularly after vaccination. We aim to investigate whether prior SARS-CoV-2 infection increases the risk of postoperative adverse outcomes in breast cancer patients and determine the optimal timing for surgical intervention during the pandemic, as well as to longitudinally assess the evolution of postoperative adverse outcomes within one year after COVID-19 and identify associated risk factors.
Detailed description
This study employs a prospective cohort design with longitudinal and matched characteristics, focusing on breast cancer patients who underwent surgery after recovering from SARS-CoV-2 infection. Patients were stratified by the time of surgery relative to COVID-19 diagnosis. The Inverse Probability of Treatment Weighting (IPTW) method was used to match a control group (COVID-19 negative) based on patient, tumor, and surgical factors in order to compare composite indicators (including death, pneumonia, thrombosis, cardiac complications, and unplanned hospitalization) for evaluating the optimal timing of surgery. We investigated the longitudinal evolution of postoperative adverse outcomes and identified the relevant risk factors through logistic regression analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative resolved COVID-19 | – | Other: Preoperative resolved COVID-19Patients who had a history of SARS-CoV-2 infection prior to surgery underwent limited breast cancer operations in the Breast Surgery Department of our hospital after recovering from SARS-CoV-2 infection between January 2023 and March 2023. |
| Preoperative COVID-19 negative | – | –Patients undergoing limited surgery for breast cancer in our Breast Surgery Department between June and August 2022 had no history of SARS-CoV-2 infection prior to surgery. However, they were diagnosed with COVID-19 after the first tumor evaluation following surgery, which occurred at least 90 days after the surgery. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The first group was the resolved COVID-19 group, which served as the experimental group and included patients who had recovered from SARS-CoV-2 infection between January 2023 and March 2023 and underwent limited breast cancer operations in our Breast Surgery Department. These patients had a history of SARS-CoV-2 infection before surgery. The second group was the pre-COVID-19 group, which served as the control group and included patients who underwent limited breast cancer operations in our Breast Surgery Department between June and August 2022 and had no history of SARS-CoV-2 infection before surgery. However, these patients were diagnosed with COVID-19 after the first tumor assessment after surgery (at least 90 days after surgery) and excluded patients who had been infected with SARS-CoV-2 within 90 days after surgery or showed distant metastases.
Key inclusion criteria (2 listed)
- Breast cancer patients who underwent surgery after recovering from SARS-CoV-2 infection
- Breast cancer patients who had never been infected with SARS-CoV-2 before surgery
Key exclusion criteria (3 listed)
- Distant metastasis
- Pregnancy-associated breast cancer
- Incomplete follow-up information
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 |
|---|---|---|
| Preoperative resolved COVID-19We observed postoperative outcomes only in patients who had or did not have COVID-19 before surgery, without any additional intervention. | Other | Preoperative resolved COVID-19 |
Primary outcome
30-day postoperative outcomes
Time frame: Within 30 days after surgery
Composite indicators (including death, pneumonia, thrombosis, cardiac complications, and unplanned hospitalization) of COVID-19-related adverse outcomes within 30 days after surgery
2 secondary outcomes
Postoperative outcomes at the time of the initial tumor assessment after surgery
Time frame: The time of the initial tumor assessment after surgery (about 90 days after surgery)
12-month postoperative outcomes
Time frame: Within 12 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
- 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. This study is not recruiting at the moment.
Chuan Wang study chair
Fujian Medical University Union Hospital
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 COVID-19, run by Fujian Medical University Union 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 2 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: status not confirmed, as of the sponsor's last update on 19 Mar 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 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?
Results are not available in the source record.
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?
30-day postoperative outcomes (time frame: Within 30 days after surgery). 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 19 Mar 2024.