Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00005783

Trial Description

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Title

A Burden-of Illness Study in Patients With Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC)

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Trial Acronym

LuCaBIS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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:

- Medical record abstraction. Medical records of eligible patients (both living and
deceased) will be reviewed, and data will be extracted for the study. Data collected
will include patient demographic and disease characteristics, details of medical care
received (including adjuvant treatment), and information about disease
recurrence/progression.

- Patient survey. Living patients will be asked to participate in a patient survey.
Living patients who agree to participate will be administered a brief patient
questionnaire to collect information that is not available in the clinical sites'
medical records [e.g., local medical care, patient out-of-pocket expenses, work loss,
and health-related quality of life (HRQOL)]. The site may exclude individual patients
from the survey if site staff feel that it would be inappropriate for that individual;
the study will not collect patient survey information from the families of deceased
patients.

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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Organizational Data

  •   DRKS00005783
  •   2014/02/17
  •   2013/01/17
  •   no
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Secondary IDs

  •   NCT01772225  (ClinicalTrials.gov)
  •   116913  (GlaxoSmithKline)
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Health Condition or Problem studied

  •   Lung Cancer, Non-Small Cell
  •   C34 -  Malignant neoplasm of bronchus and lung
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Interventions/Observational Groups

  •   Other: Data collection
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- 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.; time frame: 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.; time frame: 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.; time frame: Observation of retrospective data between 2009-2012.

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Secondary Outcome

- Determination of the characteristics of patients receiving chemotherapy compared with those not receiving chemotherapy.; time frame: 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).; time frame: Observation of retrospective data between 2009-2012.
- Evaluation of the national cost-of-illness estimates for France, Germany, and the UK.; time frame: Observation of retrospective data between 2009-2012.
- Determination of indirect costs incurred.; time frame: 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).; time frame: Observation of retrospective data between 2009-2012.
- Estimation of overall and disease-free survival of patients with resected stage IB-IIIA NSCLC observed retrospectively.; time frame: Between 01 Aug 2009 and 31 July 2012.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

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  •   2013/06/30
  •   900
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  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

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 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.

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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:

- 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.

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Addresses

  • start of 1:1-Block address primary-sponsor
    • GlaxoSmithKline
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    • RTI Health Solutions(RTI HS)
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  • start of 1:1-Block address scientific-contact
    • GlaxoSmithKline
    • GSK Clinical Trials 
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    • US GSK Clinical Trials Call Center 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   4
  •   2014/02/13
* This entry means the parameter is not applicable or has not been set.