Last updated: 03/10/2020 15:00:24
The burden of stage IB-IIIA non small cell lung cancer in Canada
GSK study ID
201087
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Other
Other
Trial overview
Official title: The burden of stage IB-IIIA non small cell lung cancer in Canada
Trial description: This is a retrospective chart review whose primary objectives are to characterize treatment patterns and burden of illness associated with stage IB-IIIA NSCLC in Canada following resection surgery, as defined by health care resource utilization and associated costs. Secondary objectives are to understand the clinical and demographic characteristics and distribution of NSCLC patients across stages IB-IIIA and between newly-diagnosed and recurrent disease, time until clinical outcomes (eg disease recurrence and death) for the overall sample and key patient characteristics and treatment regimens. The population of interest is patients receiving surgical resection for stage IB-IIIA NSCLC in Canada during an accrual period of 2007-2012, with a minimum follow up period of 2 years, for an overall study period of 2007-2014. These patients may initiate further anti-cancer therapies such as chemotherapy following resection, although this is not required for study inclusion. The study period was selected to optimize the following: an accrual period to reflect current treatment practices; an accrual period that will allow for the target number of charts to be identified at five to ten sites; and a follow up period sufficient to allow for meaningful characterization of burden of illness and some observation of long-term clinical outcomes. Between five and ten surgical and oncology sites in Canada will be included in the study. To be eligible, a site must be able to provide at least 20 eligible patient charts. Other site considerations include availability of data in individual patient charts, interest, and capacity for study participation.Resource utilization will include NSCLC related hospitalizations, outpatient visits, ER visits, laboratory and diagnostics tests and costs associated with management of AE's and palliative care.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Direct medical resource utilization and costs
Timeframe: 2 years
Secondary outcomes:
clinical and demographic characteristics and treatment patterns
Timeframe: 2 years
Survival status of the subjects
Timeframe: 2 years
Interventions:
Enrollment:
0
Primary completion date:
Not applicable
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
- 18 years of age or older, have completed resection of stage IB-IIIA NSCLC, and free of distant metastases at the time of primary diagnosis.
- Patient charts will be excluded if treatment for stage IB-IIIA NSCLC following resection was received as part of a clinical trial.
Inclusion and exclusion criteria
Inclusion criteria:
- 18 years of age or older, have completed resection of stage IB-IIIA NSCLC, and free of distant metastases at the time of primary diagnosis.
Exclusion criteria:
Patient charts will be excluded if treatment for stage IB-IIIA NSCLC following resection was received as part of a clinical trial.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Other
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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