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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01069835

Acronym

EPICLIN

Enrollment

840

Registered

2010-02-17

Start date

2010-02-28

Completion date

2012-03-31

Last updated

2015-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Small Cell Lung Cancer

Keywords

Non small cell lung cancer, EGFR mutation, NSCLC

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
To assess the differences in patient characteristics, disease stage (differentiating between non-advanced disease, locally advanced disease, metastatic disease), and in clinical management across Central Eastern European countries and Russia	24 months

Secondary

Measure	Time frame
To detect differences in clinical outcomes and related factors among countries	24 months
To identify factors associated with clinical outcomes (patient, disease stage -see above- and clinical management related factors): predictive modelling for improved patient outcome	24 months
To identify factors associated with the different levels of functional status and quality of life	24 months
To compare the use of health care resources among countries	24 months

Countries

Russia

Outcome results