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

NCT06319209 | Active Not Recruiting

• 1 other identifier: 2024KY023
• Study Type: observational
• Target: 392
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; COVID-19; Postoperative Complications

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Postoperative 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)

• 12-month postoperative outcomes

  Within 12 months after surgery

Study Arms (2)

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.

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.

Interventions

Preoperative resolved COVID-19 OTHER

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

Preoperative resolved COVID-19

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Distant metastasis
• Pregnancy-associated breast cancer
• Incomplete follow-up information

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Location

MeSH Terms

Conditions

Breast Neoplasms; COVID-19; Postoperative Complications

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chuan Wang

  Fujian Medical University Union Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Breast Surgery

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 19, 2024
• Study Start: January 1, 2023
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2024
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)