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Trial Title:
Coronavirus Infection (COVID-19) and Radical Surgery in Patients With Early-stage Lung Cancer
NCT ID:
NCT05684549
Condition:
Surgery
Corona Virus Infection
Conditions: Official terms:
Infections
Communicable Diseases
Coronavirus Infections
Virus Diseases
Lung Neoplasms
Conditions: Keywords:
Lung cancer
Surgery
Corona Virus Infection
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
No intervention
Description:
Observational study, no intervention
Arm group label:
stage I/II lung cancer patients
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.
Criteria for eligibility:
Study pop:
Patients with clinically diagnosed stage I or stage II lung cancer who are about to
receive radical surgery.
Sampling method:
Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Address:
City:
Shanghai
Zip:
200000
Country:
China
Start date:
January 11, 2023
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Ruijin Hospital
Agency class:
Other
Source:
Ruijin Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05684549