SurgeryCOVIDLungSurgNCT05684549
Coronavirus Infection (COVID-19) and Radical Surgery in Patients With Early-stage Lung Cancer
An observational study of Surgery and Corona Virus Infection, run by Ruijin Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Corona Virus Infection
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 11 Jan 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with clinically diagnosed stage I or stage II lung cancer who are about to receive radical surgery.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200000
About this study
Official title: 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.
- Conditions
- Surgery, Corona Virus Infection
- Being tested
- No intervention
- Keywords
- Lung cancer, Surgery, Corona Virus Infection
- Medical subject headings
- Coronavirus Infections, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Observational study, no intervention
| Study group | Role | What they receive |
|---|---|---|
| stage I/II lung cancer patients | Patients with stage I/II lung cancer will receive radical surgery. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative morbidity
rate of perioperative complications, mainly include: pneumonia, respiratory failure, pulmonary embolism, arrhythmia, sepsis, cerebrovascular accident, myocardial injury, acute kidney injury.
Measured: postoperative in-hospital stay up to 30 days
Secondary outcomes (6)
postoperative hospital stay
length of postoperative hospitalization
Measured: postoperative in-hospital stay up to 30 days
operation time
duration of operation
Measured: At operation day
R0 rate
R0 resection rate
Measured: postoperative in-hospital stay up to 30 days
blood loss
blood loss in the operation
Measured: At operation day
30-day mortality
30-day mortality after surgery
Measured: postoperative in-hospital stay up to 30 days
quality of life
postoperative quality of life
Measured: postoperative in-hospital stay up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start11 Jan 2023
- Primary completion30 Apr 2024
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hecheng Li M.D., Ph.D, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684549
- Sponsor's protocol ID
- RTS-017
- Acronym
- COVIDLungSurg
- Status last verified
- Jun 2024
- First submitted
- 12 Jan 2023
- Last updated
- 27 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40535078
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Coronavirus Infection (COVID-19) on the Timing and Prognosis of Radical Surgery in Patients With Early-stage Lung Cancer
- ClinicalTrials.gov ID
- NCT05684549
- Acronym / sponsor ID
- COVIDLungSurg / RTS-017
- Conditions
- Surgery, Corona Virus Infection
- Keywords
- Lung cancer, Surgery, Corona Virus Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 13 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stage I/II lung cancer patients | – | Other: No interventionPatients with stage I/II lung cancer will receive radical surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with clinically diagnosed stage I or stage II lung cancer who are about to receive radical surgery.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionObservational study, no intervention | Other | stage I/II lung cancer patients |
Primary outcome
postoperative morbidity
Time frame: postoperative in-hospital stay up to 30 days
rate of perioperative complications, mainly include: pneumonia, respiratory failure, pulmonary embolism, arrhythmia, sepsis, cerebrovascular accident, myocardial injury, acute kidney injury.
6 secondary outcomes
postoperative hospital stay
Time frame: postoperative in-hospital stay up to 30 days
operation time
Time frame: At operation day
R0 rate
Time frame: postoperative in-hospital stay up to 30 days
blood loss
Time frame: At operation day
30-day mortality
Time frame: postoperative in-hospital stay up to 30 days
quality of life
Time frame: postoperative in-hospital stay up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Derived from this study: PubMed 40535078Niu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Corona Virus Infection, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative morbidity (time frame: postoperative in-hospital stay up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05684549, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024; AzTrials last refreshed its copy on 8 Nov 2026.