Clinical trial NCT06319209: Timing of Surgery and the Evolution of Postoperative Outcomes in Breast Cancer Patients Undergoing Surgical Intervention Following Recovery From SARS-CoV-2 Infection
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
COVID-19
Postoperative Complications
Lead sponsor: Fujian Medical University Union Hospital
Sponsor class: OTHER
First posted: 2024-03-19
Enrollment: 392
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: 30-day postoperative outcomes
timeFrame: Within 30 days after surgery
Secondary outcomes:
measure: Postoperative outcomes at the time of the initial tumor assessment after surgery
timeFrame: The time of the initial tumor assessment after surgery (about 90 days after surgery)
measure: 12-month postoperative outcomes
timeFrame: Within 12 months after surgery
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Chuan Wang
role: STUDY_CHAIR
References: