NSCLC Burden of Illness Study (LuCaBIS)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01772225 |
Recruitment Status :
Completed
First Posted : January 21, 2013
Last Update Posted : March 31, 2014
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Tracking Information | ||||
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First Submitted Date | January 17, 2013 | |||
First Posted Date | January 21, 2013 | |||
Last Update Posted Date | March 31, 2014 | |||
Study Start Date | September 2013 | |||
Actual Primary Completion Date | January 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
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Original Primary Outcome Measures |
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Change History | ||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures |
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Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | NSCLC Burden of Illness Study | |||
Official Title | A Burden-of Illness Study in Patients With Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC) | |||
Brief Summary | 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. | |||
Detailed Description | 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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Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Retrospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Probability Sample | |||
Study Population | Patients (living or deceased) with complete resection (no residual disease) of stage IB-IIIA NSCLC. | |||
Condition | Lung Cancer, Non-Small Cell | |||
Intervention | Other: Data collection
Medical record abstraction form and patient survey questionnaire.
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Study Groups/Cohorts |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
1 | |||
Original Estimated Enrollment |
900 | |||
Actual Study Completion Date | January 2014 | |||
Actual Primary Completion Date | January 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria: Patient medical records will be screened using the following criteria:
Exclusion Criteria:
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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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01772225 | |||
Other Study ID Numbers | 116913 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | GlaxoSmithKline | |||
Study Sponsor | GlaxoSmithKline | |||
Collaborators | RTI Health Solutions | |||
Investigators |
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PRS Account | GlaxoSmithKline | |||
Verification Date | March 2014 |