Thoracic DiseasesNCT05827328
Explore the Optimal Surgical Timing for Lung Surgery and Mediastinal Surgery After COVID-19 Infection
An observational study of Thoracic Diseases and Thoracic Surgery, run by Shanghai Pulmonary Hospital, Shanghai, China at 6 sites in China.
Trial summary
Exploring the optimal interval time in patients with the clinical diagnosis of lung cancer or mediastinal tumors indicated for thoracic surgeries after SARS-CoV-2 infection by comparing 30-day mortality and 30-day morbidity. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Thoracic Diseases, Thoracic Surgery
- What is being tested?
- Observation
- How many people
- 2,000 participants
- Where
- 6 sitesChina
- Study dates
- 29 Jan 2023to 30 Jun 2023
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who undergo thoracic surgery for the clinical diagnosis of lung cancer or mediastinal tumors with or without SARS-CoV-2 infection.
Who may be able to join
- The patient has fully understood the nature of this study and voluntarily agreed to participate by signing an informed consent form.
- Participants of any gender between the ages of 18 and 85 are eligible.
- Preoperative imaging evaluation +/- biopsies indicates that the patient has resectable lung cancer or mediastinal tumors without distant metastasis.
Who cannot join
- Patients who have previously undergone lung surgery;
- Patients previously infected with SARS-CoV-2 more than 6 months before thoracic surgery;
- Patients who did not receive Chest computed tomography (CT) at admission or within 7 days before surgery, or whose Chest CT at admission suggests pneumonia or current infection with SARS-CoV-2 (confirmed by routine laboratory tests as positive nucleic acid in admission or on the day of surgery);
- The elapsed time from SARS-CoV-2 diagnosis to surgery is within 4 weeks;
- Local unresectable lesions or distant metastases are found intraoperatively.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Shanghai Pulmonary Hospital
Shanghai, 200433
Anhui Chest Hospital
Shanghai
Anqing Municipal Hospital
Shanghai
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
The First Affiliated Hospital of Anhui Medical University
Shanghai
Wuhan University Renmin Hospital
Shanghai
About this study
Official title: A Prospective Observational Study to Explore the Optimal Surgical Timing for Lung Surgery and Mediastinal Surgery After COVID-19 Infection
Exploring the optimal interval time in patients with the clinical diagnosis of lung cancer or mediastinal tumors indicated for thoracic surgeries after SARS-CoV-2 infection by comparing 30-day mortality and 30-day morbidity.
- Conditions
- Thoracic Diseases, Thoracic Surgery
- Being tested
- Observation
- Medical subject headings
- Thoracic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
Observe the 30-day mortality and 30-day morbidity.
| Study group | Role | What they receive |
|---|---|---|
| Patients eligible for lung surgery or mediastinal surgery | Patients with or without SARS-CoV-2 infection eligible for lung surgery or mediastinal surgery Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of perioperative mortality
30-day mortality after surgery
Measured: 30 days after surgery
Secondary outcomes (1)
The incidence of perioperative complications
30-day morbidity after surgery
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2023
- Study start29 Jan 2023
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic DiseasesStudies of the same condition, open and under way.
- More trials run by Shanghai Pulmonary Hospital, Shanghai, ChinaThe 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 (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng Zhang, Shanghai Pulmonary Hospital, Shanghai, China
- Investigators
- Peng Zhang, Principal investigator, Shanghai Pulmonary Hospital, Shanghai, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05827328
- Sponsor's protocol ID
- COVID-DS
- Status last verified
- Jul 2023
- First submitted
- 24 Apr 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study to Explore the Optimal Surgical Timing for Lung Surgery and Mediastinal Surgery After COVID-19 Infection
- ClinicalTrials.gov ID
- NCT05827328
- Acronym / sponsor ID
- COVID-DS
- Conditions
- Thoracic Diseases, Thoracic Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Shanghai Pulmonary Hospital, Shanghai, ChinaUniversity, hospital or other
- Study start
- 29 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 25 Apr 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.
Exploring the optimal interval time in patients with the clinical diagnosis of lung cancer or mediastinal tumors indicated for thoracic surgeries after SARS-CoV-2 infection by comparing 30-day mortality and 30-day morbidity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients eligible for lung surgery or mediastinal surgery | – | Other: ObservationPatients with or without SARS-CoV-2 infection eligible for lung surgery or mediastinal surgery |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who undergo thoracic surgery for the clinical diagnosis of lung cancer or mediastinal tumors with or without SARS-CoV-2 infection.
Key inclusion criteria (3 listed)
- The patient has fully understood the nature of this study and voluntarily agreed to participate by signing an informed consent form.
- Participants of any gender between the ages of 18 and 85 are eligible.
- Preoperative imaging evaluation +/- biopsies indicates that the patient has resectable lung cancer or mediastinal tumors without distant metastasis.
Key exclusion criteria (5 listed)
- Patients who have previously undergone lung surgery;
- Patients previously infected with SARS-CoV-2 more than 6 months before thoracic surgery;
- Patients who did not receive Chest computed tomography (CT) at admission or within 7 days before surgery, or whose Chest CT at admission suggests pneumonia or current infection with SARS-CoV-2 (confirmed by routine laboratory tests as positive nucleic acid in admission or on the day of surgery);
- The elapsed time from SARS-CoV-2 diagnosis to surgery is within 4 weeks;
- Local unresectable lesions or distant metastases are found intraoperatively.
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 |
|---|---|---|
| ObservationObserve the 30-day mortality and 30-day morbidity. | Other | Patients eligible for lung surgery or mediastinal surgery |
Primary outcome
The incidence of perioperative mortality
Time frame: 30 days after surgery
30-day mortality after surgery
1 secondary outcome
The incidence of perioperative complications
Time frame: 30 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Peng Zhang principal investigator
Shanghai Pulmonary Hospital, Shanghai, China
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thoracic Diseases and Thoracic Surgery, run by Shanghai Pulmonary Hospital, Shanghai, China at 6 sites 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The incidence of perioperative mortality (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2023.