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Completed

NCT Number: NCT00831909

Epidemiological Study to Describe NSCLC Clinical Management Patterns in Europe. Lung-EPICLIN

To provide accurate and reliable information regarding NSCLC clinical management across European countries in order to detect unmet medical needs of this disease in terms of: patient and hospital characteristics; diagnostic and treatment approaches: initial and subsequent, follow-up patterns in clinical management; outcomes: symptoms, death, functionality, quality of life; use of resources and burden on patients and health care systems.

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Key information

Conditions

NSCLC Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Confirmed NSCLC diagnosis (e.g. bronchoscope or FNAB), all stages, men and women, attending the responsible department of treating this type of patients for the first time between January 1st, 2009 and March 31st, 2009.
  • For PRO sub-sample: ability to read and write since they will be asked to participate in the PRO part of the study. Selection will not be based on the disease stage of each patient, in order to avoid a selection bias.

Exclusion criteria

  • According to the study design there will not be any exclusion criteria in order to provide a high external validity and to obtain the most accurate real daily practice information.

Treatment and study plan

Primary outcomes

  1. To provide accurate, reliable information on NSCLC clinical management across European countries in order to detect unmet medical needs of this disease

    Time frame: 1 year follow up

Secondary outcomes

  1. To assess the differences in patient characteristics, disease stage (differentiating between non-advanced disease, locally advanced disease, metastatic disease), and in clinical management across European countries.

    Time frame: 1 year follow up

  2. To detect differences in clinical outcomes and related factors among countries.

    Time frame: 1 year follow up

  3. To identify factors associated with clinical outcomes (patient, disease stage and clinical management related factors): predictive modelling for improved patient outcome.

    Time frame: 1 year follow up

  4. To identify factors associated with the different levels of functional status and quality of life.

    Time frame: 1 year follow up

  5. To compare the use of health care resources among countries.

    Time frame: 1 year follow up

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

Epidemiological Study to Describe Non-small Cell Lung Cancer (NSCLC) Clinical Management Patterns in Europe. Lung

Acronym: EPICLIN

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jan 29, 2009
Registry last updated
Aug 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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