Lung CancerNCT02502695
A Study to Optimize Care for Lung Cancer Patients Undergoing Video-Assisted Thoracoscopic Surgery (VATS)
An observational study of Lung Cancer, run by Dana-Farber Cancer Institute at 6 sites in United States.
Trial summary
This is a research study for participants who have been diagnosed with lung cancer and are receiving VATS (Video Assisted Thoracoscopic Surgery) lobectomy or segmentectomy. The overall objective of this study is to develop a database to collect data on participants who are undergoing VATS lobectomy or segmentectomy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- VATS-associated best practices
- How many people
- 173 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 2015to May 2019
- 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: Participants that will have VATS lobectomy and segmentectomy procedures for lung cancer
Who may be able to join
- Male and female subjects
- Age ≥ 18 years
- Underwent a VATS lobectomy or segmentectomy procedure for lung cancer -- Note: patients with other malignancies are eligible if they have a primary cancer of the lung as defined above
Who cannot join
- Subjects undergoing thoracotomy lobectomy or segmentectomy for lung cancer
- Subjects undergoing surgical procedures other than VATS lobectomy or segmentectomy for lung cancer
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
WellStar Medical Group
Austell, Georgia
Brigham and Women's Hospital
Boston, Massachusetts, 02115
North Shore University Health System
Evanston, Illinois
Providence Saint John's Health Center
Santa Monica, California, 90404
Washington University in St. Louis
St Louis, Missouri
Georgetown University Medical Center
Washington D.C., District of Columbia
About this study
Official title: A Prospective, Observational, Quality Improvement Study to Optimize Care for Lung Cancer Patients Undergoing Video-Assisted Thoracoscopic Surgery (VATS)
This is a research study for participants who have been diagnosed with lung cancer and are receiving VATS (Video Assisted Thoracoscopic Surgery) lobectomy or segmentectomy. The overall objective of this study is to develop a database to collect data on participants who are undergoing VATS lobectomy or segmentectomy for lung cancer.
Read the detailed description
This database will be used as for quality improvement purposes. Furthermore, the database will help in collecting data in an organized fashion, which will help the investigators learn more about the details of the workup performed prior to the surgery, during the surgery, peri-operative management and early follow-up. The investigators hope that this database will help to determine a common guideline to perform VATS lobectomy or segmentectomy. By creating a common guideline for future treatment of VATS patients, the investigators predict the efficiency of the process will increase significantly without decreasing, and perhaps even improving, the quality of the procedure.
- Conditions
- Lung Cancer
- Being tested
- VATS-associated best practices
- Keywords
- VATS Lobectomy and Segmentectomy for Lung Cancer, Lung Cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VATS-associated best practicesOther
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1-VATS-associated best practices | * Data to be collected will include demographic data and information about the pre-operative workup, surgical procedure, postoperative course and early discharge course for these patients.
* After the last patient completes the 30-day post surgery follow-up, the investigators will determine a set of best practices to implement at each of the sites for the quality improvement initiative. During the assessment period, no patients will be enrolled into the study. Receives: Other: VATS-associated best practices | |
| Cohort 2-VATS-associated best practices | -Once the set of VATS-associated best practices, an additional cohort of approximately 200 patients will be enrolled and followed in a manner identical to the first cohort. Receives: Other: VATS-associated best practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmissions rates within 30 days of the patient's surgery date
Measured: 30 Days
Incidence of post-operative complications within 30 days of the patient's surgery date
Measured: 30 Days
Total inpatient cost
Measured: 30 Days
Secondary outcomes (1)
Difference in readmission rates between the two cohorts
To compare current VATS-associated procedures with a set of best VATS-associated practives implemented across the participating study centers
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2017
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- 173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon Endo-Surgery
- Responsible party
- Principal investigator, Scott J. Swanson, MD, Dana-Farber Cancer Institute
- Investigators
- Scott J. Swanson, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502695
- Sponsor's protocol ID
- 15-193
- Status last verified
- Jul 2019
- First submitted
- 26 Jun 2015
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational, Quality Improvement Study to Optimize Care for Lung Cancer Patients Undergoing Video-Assisted Thoracoscopic Surgery (VATS)
- ClinicalTrials.gov ID
- NCT02502695
- Acronym / sponsor ID
- 15-193
- Conditions
- Lung Cancer
- Keywords
- VATS Lobectomy and Segmentectomy for Lung Cancer, Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Ethicon Endo-Surgery
- Study start
- Jun 2015 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 20 Jul 2015 (estimated)
- 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.
This is a research study for participants who have been diagnosed with lung cancer and are receiving VATS (Video Assisted Thoracoscopic Surgery) lobectomy or segmentectomy. The overall objective of this study is to develop a database to collect data on participants who are undergoing VATS lobectomy or segmentectomy for lung cancer.
Detailed description
This database will be used as for quality improvement purposes. Furthermore, the database will help in collecting data in an organized fashion, which will help the investigators learn more about the details of the workup performed prior to the surgery, during the surgery, peri-operative management and early follow-up. The investigators hope that this database will help to determine a common guideline to perform VATS lobectomy or segmentectomy. By creating a common guideline for future treatment of VATS patients, the investigators predict the efficiency of the process will increase significantly without decreasing, and perhaps even improving, the quality of the procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1-VATS-associated best practices | – | Other: VATS-associated best practices* Data to be collected will include demographic data and information about the pre-operative workup, surgical procedure, postoperative course and early discharge course for these patients. * After the last patient completes the 30-day post surgery follow-up, the investigators will determine a set of best practices to implement at each of the sites for the quality improvement initiative. During the assessment period, no patients will be enrolled into the study. |
| Cohort 2-VATS-associated best practices | – | Other: VATS-associated best practices-Once the set of VATS-associated best practices, an additional cohort of approximately 200 patients will be enrolled and followed in a manner identical to the first cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants that will have VATS lobectomy and segmentectomy procedures for lung cancer
Key inclusion criteria (3 listed)
- Male and female subjects
- Age ≥ 18 years
- Underwent a VATS lobectomy or segmentectomy procedure for lung cancer -- Note: patients with other malignancies are eligible if they have a primary cancer of the lung as defined above
Key exclusion criteria (2 listed)
- Subjects undergoing thoracotomy lobectomy or segmentectomy for lung cancer
- Subjects undergoing surgical procedures other than VATS lobectomy or segmentectomy for lung cancer
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-associated best practices | Other | Cohort 1-VATS-associated best practices, Cohort 2-VATS-associated best practices |
Primary outcome
Readmissions rates within 30 days of the patient's surgery date
Time frame: 30 Days
Incidence of post-operative complications within 30 days of the patient's surgery date
Time frame: 30 Days
Total inpatient cost
Time frame: 30 Days
1 secondary outcome
Difference in readmission rates between the two cohorts
Time frame: 3 years
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 13 Jan 2020.
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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.
Scott J. Swanson, MD principal investigator
Brigham and Women's Hospital
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 Lung Cancer, run by Dana-Farber Cancer Institute at 6 sites in United States.
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 2 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 13 Jan 2020. 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 United States. 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?
Readmissions rates within 30 days of the patient's surgery date (time frame: 30 Days). The study lists 3 primary outcomes in all. 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 13 Jan 2020.