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Lung Cancer, Non-Small CellLuCaBISNCT01772225

NSCLC Burden of Illness Study

An observational study of Lung Cancer, Non-Small Cell, run by GlaxoSmithKline.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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]). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lung Cancer, Non-Small Cell
What is being tested?
Data collection
How many people
1 participants
Where
No sites listed yet
Study dates
Sep 2013to Jan 2014
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients (living or deceased) with complete resection (no residual disease) of stage IB-IIIA NSCLC.

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

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

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.

Read the 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:

  • 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.

Being tested
Data collection
Keywords
Observational Retrospective, Health-related quality of life (HRQoL), Patients, Stage IB-IIIA, Burden of Illness, Non-small Cell Lung Cancer (NSCLC)
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Data collectionOther

    Medical record abstraction form and patient survey questionnaire.

Study groups in NCT01772225
Study groupRoleWhat they receive
Deceased GroupSubjects in this group will include the deceased patients from each of the three countries.
Receives: Other: Data collection
Living GroupSubjects in this group will include living patients aged 18 years or older from each of the three countries.
Receives: Other: Data collection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Observation of retrospective data between 2009-2012.

  2. Determinations of the proportions of patients receiving each type of adjuvant chemotherapy and proportions receiving no adjuvant chemotherapy.

    Measured: Observation of retrospective data between 2009-2012.

  3. 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.

    Measured: Observation of retrospective data between 2009-2012.

Secondary outcomes (6)

  1. Determination of the characteristics of patients receiving chemotherapy compared with those not receiving chemotherapy.

    Measured: Observation of retrospective data between 2009-2012.

  2. Determination of the proportion of patients with selected co morbidities (e.g., chronic obstructive pulmonary disease [COPD], cardiovascular disease, asthma).

    Measured: Observation of retrospective data between 2009-2012.

  3. Evaluation of the national cost-of-illness estimates for France, Germany, and the UK.

    Measured: Observation of retrospective data between 2009-2012.

  4. Determination of indirect costs incurred.

    Measured: Observation of retrospective data between 2009-2012.

  5. 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).

    Measured: Observation of retrospective data between 2009-2012.

  6. Estimation of overall and disease-free survival of patients with resected stage IB-IIIA NSCLC observed retrospectively.

    Measured: Between 01 Aug 2009 and 31 July 2012.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2013 (estimated)
  2. Study startSep 2013
  3. Primary completionJan 2014
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01772225
Sponsor's protocol ID
116913
Acronym
LuCaBIS
Status last verified
Mar 2014
First submitted
17 Jan 2013
Last updated
31 Mar 2014
Results posted
No

Publications

  • 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.

    PubMed 30119925

  • 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.

    PubMed 29961557

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Cancer, Non-Small Cell, run by GlaxoSmithKline.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01772225, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2014.

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