NCT05684549

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 11, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 12, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

1.3 years

First QC Date

January 12, 2023

Last Update Submit

June 25, 2024

Conditions

SurgeryCorona Virus Infection

Keywords

Lung cancerSurgeryCorona Virus Infection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • postoperative hospital stay

    postoperative in-hospital stay up to 30 days

  • operation time

    At operation day

  • R0 rate

    postoperative in-hospital stay up to 30 days

  • blood loss

    At operation day

  • 30-day mortality

    postoperative in-hospital stay up to 30 days

  • +1 more secondary outcomes

Study Arms (1)

stage I/II lung cancer patients

Patients with stage I/II lung cancer will receive radical surgery.

Other: No intervention

Interventions

No interventionOTHER

Observational study, no intervention

stage I/II lung cancer patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (1)

  • Niu Z, Zhu F, Cao Y, Luo C, Liu D, Wang C, Qiu Z, Peng L, Du M, Jin R, Yan Y, Dong D, Jing H, Wang X, Guo W, Guo Z, Li C, Han D, Zhang Y, Xiang J, Du H, Chen K, Yin Z, Yang J, Zhong W, Zhou Y, Wang M, Ma D, Li H. Impact of coronavirus disease 2019 on surgery in patients with early-stage lung cancer: the COVIDLungSurg prospective cohort study. Transl Lung Cancer Res. 2025 May 30;14(5):1677-1687. doi: 10.21037/tlcr-2024-1276. Epub 2025 May 28.

    PMID: 40535078DERIVED

MeSH Terms

Conditions

Coronavirus InfectionsLung Neoplasms

Condition Hierarchy (Ancestors)

Coronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsVirus DiseasesInfectionsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 12, 2023

First Posted

January 13, 2023

Study Start

January 11, 2023

Primary Completion

April 30, 2024

Study Completion

December 31, 2024

Last Updated

June 27, 2024

Record last verified: 2024-06

Locations

CN(1)