Last updated: 11/03/2018 19:46:12
NSCLC Burden of Illness studyLuCaBIS
GSK study ID
116913
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Burden-of Illness Study in Patients with Stage IB-IIIA Non–small Cell Lung Cancer (NSCLC)
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
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.
Timeframe: 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.
Timeframe: 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.
Timeframe: Observation of retrospective data between 2009-2012.
Secondary outcomes:
Determination of the characteristics of patients receiving chemotherapy compared with those not receiving chemotherapy.
Timeframe: 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).
Timeframe: Observation of retrospective data between 2009-2012.
Evaluation of the national cost-of-illness estimates for France, Germany, and the UK.
Timeframe: Observation of retrospective data between 2009-2012.
Determination of indirect costs incurred.
Timeframe: 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).
Timeframe: Observation of retrospective data between 2009-2012.
Estimation of overall and disease-free survival of patients with resected stage IB-IIIA NSCLC observed retrospectively.
Timeframe: Between 01 Aug 2009 and 31 July 2012.
Interventions:
Enrollment:
1
Primary completion date:
Not applicable
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Lung Cancer, Non-Small Cell
Product
GSK2999274A
Collaborators
RTI Health Solutions
Study date(s)
September 2013 to December 2013
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Patient medical records will be screened using the following criteria:
- Patients must be aged 18 years or older at the time of first presentation with clinical stage IB-IIIA NSCLC.
- 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)].
Inclusion and exclusion criteria
Inclusion criteria:
- Patients must be aged 18 years or older at the time of first presentation with clinical stage IB-IIIA NSCLC.
- Patients must have complete resection of pathologic stage IB-IIIA NSCLC at least 1 calendar month prior to the date of screening, according to the current classification recommended by the International Association for the Study of Lung Cancer (2009). The investigator/study site must have been the main care provider for the patient during the period of treatment or management of the patient’s NSCLC.
Patient medical records will be screened using the following criteria:
Exclusion criteria:
- 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:
- Living patients who are no longer under the care of the site or can no longer be contacted.
- Deceased patients who were transferred to another NSCLC treatment centre before death. Patients with concomitant malignancies who received treatment for other cancers at any time during their treatment or follow-up for NSCLC.
Patients who underwent wedge resection.
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
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2013-23-12
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website