Coronavirus Infection (COVID-19) and Radical Surgery in Patients With Early-stage Lung Cancer (COVIDLungSurg)

Effects of Coronavirus Infection (COVID-19) on the Timing and Prognosis of Radical Surgery in Patients With Early-stage Lung Cancer

The goal of this observational study is to learn about the effects of coronavirus infection in patients with early-stage lung cancer. The main question it aims to answer is whether the interval of surgery and COVID-19 infection will affect the surgery and prognosis of the patients.

Study Overview

• Status: Active, not recruiting
• Conditions: Surgery; Corona Virus Infection
• Intervention / Treatment: Other: No intervention

• Study Type: Observational
• Enrollment (Estimated): 2000

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200000
      • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with clinically diagnosed stage I or stage II lung cancer who are about to receive radical surgery.

Description

Inclusion Criteria:

• Clinically diagnosed stage I and stage II lung cancer, who are about to receive wedge resection, segmental resection, sleeve resection, lobectomy, or pneumonectomy under general anaesthesia.
• Volunteer to participate in the study with good compliance. Able to complete the observation and follow-up and have signed the informed consent.
• ASA score: I-III;
• Cardiopulmonary functions meet the requirements of radical operation for lung cancer with normal liver and kidney functions.

Exclusion Criteria:

• Neurologic, mental illness or mental disorder which is hard to control, poor compliance, unable to cooperate or describe the treatment response;
• Clinically diagnosed stage III and stage IV lung cancer or patients who received neoadjuvant treatment before surgery;
• Patients developed symptoms alike coronavirus infection but are not confirmed by viral RNA detection by quantitative RT-PCR or antigen testing kits.
• Serious heart, lung, liver and kidney dysfunction and unable to tolerate the operation

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
stage I/II lung cancer patients; Patients with stage I/II lung cancer will receive radical surgery.	Other: No intervention; Observational study, no intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative morbidity	rate of perioperative complications, mainly include: pneumonia, respiratory failure, pulmonary embolism, arrhythmia, sepsis, cerebrovascular accident, myocardial injury, acute kidney injury.	postoperative in-hospital stay up to 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
R0 rate	R0 resection rate	postoperative in-hospital stay up to 30 days
operation time	duration of operation	At operation day
blood loss	blood loss in the operation	At operation day
postoperative hospital stay	length of postoperative hospitalization	postoperative in-hospital stay up to 30 days
30-day mortality	30-day mortality after surgery	postoperative in-hospital stay up to 30 days
quality of life	postoperative quality of life	postoperative in-hospital stay up to 30 days

Collaborators and Investigators

• Sponsor: Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2023
• Primary Completion (Actual): April 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: January 12, 2023
• First Submitted That Met QC Criteria: January 12, 2023
• First Posted (Actual): January 13, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 25, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Surgery; Lung cancer; Corona Virus Infection
• Additional Relevant MeSH Terms: Pathologic Processes; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Disease Attributes; Respiratory Tract Neoplasms; Thoracic Neoplasms; Coronavirus Infections; Lung Neoplasms; Infections; Communicable Diseases; Virus Diseases
• Other Study ID Numbers: RTS-017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No