Long-term Epidemiological Follow-up of Non-small Cell Lung Cancer in Scandinavia

Study Overview
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Brief Summary
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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.

Official Title
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Long-term Epidemiological Follow-up of Non-small Cell Lung Cancer in Scandinavia

Conditions
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Non-Small Cell Lung Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with a histologically confirmed diagnosis of NSCLC (squamous, adenocarcinoma, not otherwise specified NSCLC [NSCLC NOS]) identified in the Cancer registers Exclusion Criteria: Age under 18 years at time of diagnosis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1: National patient cohorts in Scandinavia<br>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)<br>Patient as data is available ( 2010) to 2013 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | Approximately 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index (BMI) of NSCLC patients at diagnosis |  | At baseline visit | 
| Smoking habits of NSCLC patients at diagnosis |  | At baseline visit | 
| Age of NSCLC patients at diagnosis |  | At baseline visit | 
| NSCLC clinical subtype of NSCLC patients at diagnosis |  | At baseline visit | 
| Tumor node metastasis classification of NSCLC patients at diagnosis |  | At baseline visit | 
| Charlson Comorbidity index of NSCLC patients at diagnosis |  | At baseline visit | 
| Drug utilization after NSCLC diagnosis by line of therapy |  | Approximately 2 years | 
| Proportion of patients who receive surgery by stage at treatment |  | Approximately 2 years | 
| Proportion of patients who receive radiation by stage at treatment |  | Approximately 2 years |