Non-Small Cell Lung CancerSCAN-LEAFNCT02839629
Long-term Epidemiological Follow-up of Non-small Cell Lung Cancer in Scandinavia
An observational study of Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb.
Trial summary
A study to describe and evaluate patient characteristics and clinical outcomes in Subjects with diagnosed Non Small Lung Cell Cancer in Sweden, Norway and Denmark. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- How many people
- 5,657 participants
- Where
- No sites listed yet
- Study dates
- 23 Nov 2015to 7 May 2021
- 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 a diagnosis of NSCLC
Who may be able to join
- Patients with a histologically confirmed diagnosis of NSCLC (squamous, adenocarcinoma, not otherwise specified NSCLC [NSCLC NOS]) identified in the Cancer registers
Who cannot join
- Age under 18 years at time of diagnosis
About this study
A study to describe and evaluate patient characteristics and clinical outcomes in Subjects with diagnosed Non Small Lung Cell Cancer in Sweden, Norway and Denmark.
- Conditions
- Non-Small Cell Lung Cancer
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: National patient cohorts in Scandinavia | Scandinavian countries: Denmark, Norway and Sweden Cohort 1 will include all patients with a diagnosis of NSCLC between 2005 and 2013 | |
| Cohort 2: Electronic Medical Records based cohort (Sweden) | Patient as data is available (~2010) to 2013 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival based on Response Evaluation Criteria in Solid Tumors (RECIST)
Overall survival is defined as the time from start of treatment to the end of follow-up; Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease
Measured: Approximately 2 years
Progression free survival based on Response Evaluation Criteria in Solid Tumors (RECIST)
Progression free survival is defined as the time from date of treatment start to either the first disease progression date or last known tumor assessment date or death; Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease
Measured: Approximately 2 years
Time to progression based on Response Evaluation Criteria in Solid Tumors (RECIST)
Time to progression is defined as time from start of therapy until tumor progression; Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease
Measured: Approximately 2 years
Disease control rate; defined as total number of patients whose Best Overall Response(BOR)= Complete Response(CR), Partial Response(PR) or Stable Disease(SD), divided by total number of patients
Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease; BOR: Best Overall Response, CR: Complete Response, PR: Partial Response, SD: Stable Disease
Measured: Approximately 2 years
Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST)
Partial response is defined as a record of at least a 30% decrease in the sum of diameters of target lesions, from the baseline sum; Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease
Measured: Approximately 2 years
Complete response based on Response Evaluation Criteria in Solid Tumors (RECIST)
Complete response is defined as a record of disappearance of all target lesions; Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease
Measured: Approximately 2 years
Percent of patients with an adverse event (AE)
Patients with advanced stage (stage IIIB and above) disease; AEs are defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
Measured: Approximately 2 years
Percent of patients with an adverse event (AE)
Patients with earlier stage (stages I to IIA) disease; AEs are defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
Measured: Approximately 2 years
Secondary outcomes (9)
Body Mass Index (BMI) of NSCLC patients at diagnosis
Measured: At baseline visit
Smoking habits of NSCLC patients at diagnosis
Measured: At baseline visit
Age of NSCLC patients at diagnosis
Measured: At baseline visit
NSCLC clinical subtype of NSCLC patients at diagnosis
Measured: At baseline visit
Tumor node metastasis classification of NSCLC patients at diagnosis
Measured: At baseline visit
Charlson Comorbidity index of NSCLC patients at diagnosis
Measured: At baseline visit
Drug utilization after NSCLC diagnosis by line of therapy
Measured: Approximately 2 years
Proportion of patients who receive surgery by stage at treatment
Measured: Approximately 2 years
Proportion of patients who receive radiation by stage at treatment
Measured: Approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start23 Nov 2015
- Primary completion31 Jan 2020
- Study completion7 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe 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
- Retrospective
- Enrolment
- 5,657 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839629
- Sponsor's protocol ID
- CA209-319
- Acronym
- SCAN-LEAF
- Status last verified
- Jan 2022
- First submitted
- 12 Jul 2016
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Epidemiological Follow-up of Non-small Cell Lung Cancer in Scandinavia
- ClinicalTrials.gov ID
- NCT02839629
- Acronym / sponsor ID
- SCAN-LEAF / CA209-319
- Conditions
- Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,657 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2015 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 7 May 2021 (actual)
- First posted
- 21 Jul 2016 (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.
A study to describe and evaluate patient characteristics and clinical outcomes in Subjects with diagnosed Non Small Lung Cell Cancer in Sweden, Norway and Denmark.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: National patient cohorts in Scandinavia | – | –Scandinavian countries: Denmark, Norway and Sweden Cohort 1 will include all patients with a diagnosis of NSCLC between 2005 and 2013 |
| Cohort 2: Electronic Medical Records based cohort (Sweden) | – | –Patient as data is available (~2010) to 2013 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a diagnosis of NSCLC
Key inclusion criteria (1 listed)
- Patients with a histologically confirmed diagnosis of NSCLC (squamous, adenocarcinoma, not otherwise specified NSCLC [NSCLC NOS]) identified in the Cancer registers
Key exclusion criteria (1 listed)
- Age under 18 years at time of diagnosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Overall survival based on Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Approximately 2 years
Overall survival is defined as the time from start of treatment to the end of follow-up; Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease
Progression free survival based on Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Approximately 2 years
Progression free survival is defined as the time from date of treatment start to either the first disease progression date or last known tumor assessment date or death; Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease
Time to progression based on Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Approximately 2 years
Time to progression is defined as time from start of therapy until tumor progression; Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease
Disease control rate; defined as total number of patients whose Best Overall Response(BOR)= Complete Response(CR), Partial Response(PR) or Stable Disease(SD), divided by total number of patients
Time frame: Approximately 2 years
Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease; BOR: Best Overall Response, CR: Complete Response, PR: Partial Response, SD: Stable Disease
Partial Response (PR) based on Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Approximately 2 years
Partial response is defined as a record of at least a 30% decrease in the sum of diameters of target lesions, from the baseline sum; Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease
Complete response based on Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Approximately 2 years
Complete response is defined as a record of disappearance of all target lesions; Clinical outcomes will be assessed among NSCLC patients with advanced (stage IIIB and above) and earlier stage (stages I to IIIA) disease
Percent of patients with an adverse event (AE)
Time frame: Approximately 2 years
Patients with advanced stage (stage IIIB and above) disease; AEs are defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
Percent of patients with an adverse event (AE)
Time frame: Approximately 2 years
Patients with earlier stage (stages I to IIA) disease; AEs are defined as any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product
9 secondary outcomes
Body Mass Index (BMI) of NSCLC patients at diagnosis
Time frame: At baseline visit
Smoking habits of NSCLC patients at diagnosis
Time frame: At baseline visit
Age of NSCLC patients at diagnosis
Time frame: At baseline visit
NSCLC clinical subtype of NSCLC patients at diagnosis
Time frame: At baseline visit
Tumor node metastasis classification of NSCLC patients at diagnosis
Time frame: At baseline visit
Charlson Comorbidity index of NSCLC patients at diagnosis
Time frame: At baseline visit
Drug utilization after NSCLC diagnosis by line of therapy
Time frame: Approximately 2 years
Proportion of patients who receive surgery by stage at treatment
Time frame: Approximately 2 years
Proportion of patients who receive radiation by stage at treatment
Time frame: Approximately 2 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 24 Feb 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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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.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Small Cell Lung Cancer, run by Bristol-Myers Squibb.
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 1 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 24 Feb 2022. 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?
Overall survival based on Response Evaluation Criteria in Solid Tumors (RECIST) (time frame: Approximately 2 years). The study lists 8 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 24 Feb 2022.