Timing of Surgery and the Evolution of Postoperative Outcomes in Breast Cancer Patients Undergoing Surgical Intervention Following Recovery From SARS-CoV-2 Infection

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06319209
• Other study ID #: 2024KY023
• Status: Active, not recruiting
• Start date: January 1, 2023
• Est. completion date: March 31, 2024

Study information

• Verified date: March 2024
• Source: Fujian Medical University Union Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 392
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Distant metastasis

• Pregnancy-associated breast cancer

• Incomplete follow-up information

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• COVID-19
• Postoperative Complications

Intervention

Other:
• Preoperative resolved COVID-19
We observed postoperative outcomes only in patients who had or did not have COVID-19 before surgery, without any additional intervention.

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University Union Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Within 30 days after surgery
Secondary	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	The time of the initial tumor assessment after surgery (about 90 days after surgery)
Secondary	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	Within 12 months after surgery