Lung CancerNCT04799509
Assessment of the 90-day Mortality Risk Score After VATS Lobectomy
An observational study of Lung Cancer and Surgery--Complications, run by Università degli Studi dell'Insubria.
Trial summary
A five classes (A-E) aggregate risk score predicting 90-day mortality after video-assisted thoracoscopic lobectomy for lung cancer, including as independent factors male sex (3 points), carbon monoxide lung diffusion capacity <60% (1 point) and operative time >150 minutes (1 point), has been recently published. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer, Surgery--Complications, Morality
- What is being tested?
- VATS lobectomy
- Type of treatment
- Surgery or procedure
- How many people
- 2,209 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 27 Nov 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients were selected from the Italian VATS Group registry (a database containing prospectively collected data on VATS anatomical lung resection performed in 58 certified thoracic surgery centers from January 1st 2014). The VATS Group database was awarded by the European Society of Thoracic Surgeons in the 2017
Who may be able to join
- Patients undergoing VATS lobectomy for non-small cell lung cancer
Who cannot join
- Incomplete data for risk score calculation
- Tumor size >5 cm
- Follow-up <3 months
- Patients undergoing neoadjuvant treatment
- Patients undergoing extended resection
About this study
Official title: Assessment of the 90-day Mortality Risk Score After Video-assisted Thoracoscopic Lobectomy in the Italian VATS Group Cohort
A five classes (A-E) aggregate risk score predicting 90-day mortality after video-assisted thoracoscopic lobectomy for lung cancer, including as independent factors male sex (3 points), carbon monoxide lung diffusion capacity <60% (1 point) and operative time >150 minutes (1 point), has been recently published. This study aims to assess the effectiveness and reliability of this risk model in a large, independent cohort of patients, in order to confirm its generalizability.
Read the detailed description
From the Italian VATS Group Database, we selected patients who underwent video-assisted thoracoscopic lobectomy for non-small cell lung cancer. We calculated the aggregate risk score and the corresponding class of 90-day mortality risk for each patient. The correlation between risk classes and mortality rates was tested by Spearman's rho-test. Model calibration was evaluated by Hosmer-Lemeshow goodness-of-fit test.
- Conditions
- Lung Cancer, Surgery--Complications, Morality
- Being tested
- VATS lobectomy
- Keywords
- non-small cell lung cancer, VATS lobectomy, 90-day postoperative mortality, risk score, validation
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VATS lobectomyProcedure or surgery
VATS lobectomy
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day postoperative mortality
Alive/Death (cause of death)
Measured: 90 day post surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study start1 Jan 2014
- Primary completion27 Nov 2018
- Study completion27 Nov 2018
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 Lung CancerStudies of the same condition, open and under way.
- 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
- 2,209 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Cattoni, Università degli Studi dell'Insubria
- Investigators
- Andrea Imperatori, MD, Study director, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04799509
- Sponsor's protocol ID
- VALIDATION
- Status last verified
- Mar 2021
- First submitted
- 12 Mar 2021
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Brunelli A, Dinesh P, Woodcock-Shaw J, Littlechild D, Pompili C. Ninety-Day Mortality After Video-Assisted Thoracoscopic Lobectomy: Incidence and Risk Factors. Ann Thorac Surg. 2017 Sep;104(3):1020-1026. doi: 10.1016/j.athoracsur.2017.02.083. Epub 2017 Jun 1.
PubMed 28577845
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the 90-day Mortality Risk Score After Video-assisted Thoracoscopic Lobectomy in the Italian VATS Group Cohort
- ClinicalTrials.gov ID
- NCT04799509
- Acronym / sponsor ID
- VALIDATION
- Conditions
- Lung Cancer, Surgery--Complications, Morality
- Keywords
- non-small cell lung cancer, VATS lobectomy, 90-day postoperative mortality, risk score, validation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,209 participants (actual)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 27 Nov 2018 (actual)
- Study completion
- 27 Nov 2018 (actual)
- First posted
- 16 Mar 2021 (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.
A five classes (A-E) aggregate risk score predicting 90-day mortality after video-assisted thoracoscopic lobectomy for lung cancer, including as independent factors male sex (3 points), carbon monoxide lung diffusion capacity <60% (1 point) and operative time >150 minutes (1 point), has been recently published. This study aims to assess the effectiveness and reliability of this risk model in a large, independent cohort of patients, in order to confirm its generalizability.
Detailed description
From the Italian VATS Group Database, we selected patients who underwent video-assisted thoracoscopic lobectomy for non-small cell lung cancer. We calculated the aggregate risk score and the corresponding class of 90-day mortality risk for each patient. The correlation between risk classes and mortality rates was tested by Spearman's rho-test. Model calibration was evaluated by Hosmer-Lemeshow goodness-of-fit test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients were selected from the Italian VATS Group registry (a database containing prospectively collected data on VATS anatomical lung resection performed in 58 certified thoracic surgery centers from January 1st 2014). The VATS Group database was awarded by the European Society of Thoracic Surgeons in the 2017
Key inclusion criteria (1 listed)
- Patients undergoing VATS lobectomy for non-small cell lung cancer
Key exclusion criteria (5 listed)
- Incomplete data for risk score calculation
- Tumor size >5 cm
- Follow-up <3 months
- Patients undergoing neoadjuvant treatment
- Patients undergoing extended resection
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 |
|---|---|---|
| VATS lobectomyVATS lobectomy | Procedure or surgery | – |
Primary outcome
90-day postoperative mortality
Time frame: 90 day post surgical procedure
Alive/Death (cause of death)
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 22 Mar 2021.
- Background: PubMed 28577845Brunelli A, Dinesh P, Woodcock-Shaw J, Littlechild D, Pompili C. Ninety-Day Mortality After Video-Assisted Thoracoscopic Lobectomy: Incidence and Risk Factors. Ann Thorac Surg. 2017 Sep;104(3):1020-1026. doi: 10.1016/j.athoracsur.2017.02.083. Epub 2017 Jun 1.
- 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.
Andrea Imperatori, MD study director
Università degli Studi dell'Insubria
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Surgery--Complications, run by Università degli Studi dell'Insubria.
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 1 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 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
90-day postoperative mortality (time frame: 90 day post surgical procedure). 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 NCT04799509, 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 22 Mar 2021.