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Epidemiological Study to Describe Non Small Cell Lung Cancer (NSCLC) Clinical Management Patterns in Central Eastern Europe and Russia (Lung-EPICLIN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01069835
First received: February 15, 2010
Last updated: February 4, 2013
Last verified: February 2013

February 15, 2010
February 4, 2013
February 2010
March 2011   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01069835 on ClinicalTrials.gov Archive Site
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Epidemiological Study to Describe Non Small Cell Lung Cancer (NSCLC) Clinical Management Patterns in Central Eastern Europe and Russia (Lung-EPICLIN)
Epidemiological Study to Describe NSCLC Clinical Management Patterns in Central Eastern Europe and Russia. Lung-EPICLIN

The overall aim of the study is:

To provide accurate and reliable information regarding NSCLC clinical management across Central Eastern European countries and Russia 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. Addendum objective is to collect epidemiological data on EGFR mutation status (M+, M-) in the Russian population
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Paraffin embedded tumour tissue samples

Non-Probability Sample

Cancer patients from Oncological Dispensaries and Cancer Research Institutes

Non Small Cell Lung Cancer
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1
Non-small cell lung cancer patients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
840
March 2012
March 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Confirmed NSCLC diagnosis (e.g.bronchoscopic biopsy or FNAB), all stages, men and women, attending the responsible department of treating this type of patients for the first time between January 1st, 2010 and March 31st, 2010
  • For Patient Reported Outcome (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.
  • Tumour tissue samples (in paraffin-embedded blocks) suitable for EGFR mutation testing available.

Exclusion Criteria:

  • Mixed histology of small cell and non-small cell lung cancer.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Russian Federation
 
NCT01069835
NIS-ORU-IRE-2009/1
No
AstraZeneca
AstraZeneca
Not Provided
Not Provided
AstraZeneca
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP