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| Name | Class |
|---|---|
| RTI Health Solutions | OTHER |
The aim of this observational study is to identify and quantify the humanistic and economic burden of illness of patients with complete resection (no residual disease) of stage IB-IIIA NSCLC in three European countries (France, Germany, and the United Kingdom [UK]). Data collection will be conducted through patient medical record abstraction and patient survey.
The study procedures will have no effect on the medical care delivered to enrolled patients. Physicians will continue to provide usual medical care to patients. There is no study intervention, and no drug or other intervention will be provided to the site as part of the study.
Methodology: the study will consist of two components:
Informed consent will be collected from living patients who participate in the patient survey, apart from the abstraction of their medical records. Country-specific requirements will be followed.
The medical records of patients (living or deceased) with complete resection of stage IB-IIIA NSCLC between 01 August 2009 and 31 July 2012 will be identified. No vaccine or drug was administered during this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deceased Group | Subjects in this group will include the deceased patients from each of the three countries. |
| |
| Living Group | Subjects in this group will include living patients aged 18 years or older from each of the three countries. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection | Other | Medical record abstraction form and patient survey questionnaire. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the adjuvant therapies used in routine practice in the target countries along with the durations of treatment, doses, dose reduction rates, discontinuation rates, and reasons for discontinuation. | Observation of retrospective data between 2009-2012. | |
| Determinations of the proportions of patients receiving each type of adjuvant chemotherapy and proportions receiving no adjuvant chemotherapy. | Observation of retrospective data between 2009-2012. | |
| Determination of the level of medical resource utilization and the direct healthcare costs of managing these patients during adjuvant treatment, prior to disease recurrence/progression, and post disease recurrence/progression. | Observation of retrospective data between 2009-2012. |
| Measure | Description | Time Frame |
|---|---|---|
| Determination of the characteristics of patients receiving chemotherapy compared with those not receiving chemotherapy. | Observation of retrospective data between 2009-2012. | |
| Determination of the proportion of patients with selected co morbidities (e.g., chronic obstructive pulmonary disease [COPD], cardiovascular disease, asthma). |
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Inclusion Criteria:
Patient medical records will be screened using the following criteria:
Exclusion Criteria:
Patients who underwent wedge resection.
Patients whose resection was less than 1 calendar month before the date of screening. Patients who received adjuvant systemic treatment within a clinical trial if the type of adjuvant treatment is either unknown or is not recommended by international clinical guidelines [European Society for Medical Oncology (ESMO), National Comprehensive Cancer Network (NCCN)].
Patients who are lost to follow-up:
Patients with concomitant malignancies who received treatment for other cancers at any time during their treatment or follow-up for NSCLC.
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Patients (living or deceased) with complete resection (no residual disease) of stage IB-IIIA NSCLC.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30119925 | Derived | Chouaid C, Danson S, Andreas S, Siakpere O, Benjamin L, Ehness R, Dramard-Goasdoue MH, Barth J, Hoffmann H, Potter V, Barlesi F, Price M, Chirila C, Hollis K, Sweeney C, Wolowacz S, Kaye JA, Kontoudis I. Adjuvant treatment patterns and outcomes in patients with stage IB-IIIA non-small cell lung cancer in France, Germany, and the United Kingdom based on the LuCaBIS burden of illness study. Lung Cancer. 2018 Oct;124:310-316. doi: 10.1016/j.lungcan.2018.07.042. Epub 2018 Aug 10. | |
| 29961557 |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D003625 | Data Collection |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
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| Observation of retrospective data between 2009-2012. |
| Evaluation of the national cost-of-illness estimates for France, Germany, and the UK. | Observation of retrospective data between 2009-2012. |
| Determination of indirect costs incurred. | Observation of retrospective data between 2009-2012. |
| Determination of the effect of the disease on Health related quality of life (HRQOL) based on EuroQol 5 Dimensions quality-of-life questionnaire (EQ-5D). | Observation of retrospective data between 2009-2012. |
| Estimation of overall and disease-free survival of patients with resected stage IB-IIIA NSCLC observed retrospectively. | Between 01 Aug 2009 and 31 July 2012. |
| Derived |
| Andreas S, Chouaid C, Danson S, Siakpere O, Benjamin L, Ehness R, Dramard-Goasdoue MH, Barth J, Hoffmann H, Potter V, Barlesi F, Chirila C, Hollis K, Sweeney C, Price M, Wolowacz S, Kaye JA, Kontoudis I. Economic burden of resected (stage IB-IIIA) non-small cell lung cancer in France, Germany and the United Kingdom: A retrospective observational study (LuCaBIS). Lung Cancer. 2018 Oct;124:298-309. doi: 10.1016/j.lungcan.2018.06.007. Epub 2018 Jun 9. |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |