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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) (EPICLIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01069835
Recruitment Status : Completed
First Posted : February 17, 2010
Last Update Posted : May 19, 2015
Information provided by (Responsible Party):

Study Description
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

Condition or disease
Non Small Cell Lung Cancer

Study Design

Study Type : Observational
Actual Enrollment : 840 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiological Study to Describe NSCLC Clinical Management Patterns in Central Eastern Europe and Russia. Lung-EPICLIN
Study Start Date : February 2010
Primary Completion Date : March 2011
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Groups and Cohorts

Non-small cell lung cancer patients

Outcome Measures

Primary Outcome Measures :
  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 Central Eastern European countries and Russia [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. To detect differences in clinical outcomes and related factors among countries [ Time Frame: 24 months ]
  2. To identify factors associated with clinical outcomes (patient, disease stage -see above- and clinical management related factors): predictive modelling for improved patient outcome [ Time Frame: 24 months ]
  3. To identify factors associated with the different levels of functional status and quality of life [ Time Frame: 24 months ]
  4. To compare the use of health care resources among countries [ Time Frame: 24 months ]

Biospecimen Retention:   Samples With DNA
Paraffin embedded tumour tissue samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cancer patients from Oncological Dispensaries and Cancer Research Institutes

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01069835

Russian Federation
Research Site
Barnaul, Altaiskiy Krai, Russian Federation
Research Site
Birobidzhan, EAO, Russian Federation
Research Site
Khabarovsk, Khabarovskiy Krai, Russian Federation
Research Site
Khanty-Mansyisk, Khanty-Mansyiskyi AO, Russian Federation
Research Site
Krasnodar, Krasnodarskiy Krai, Russian Federation
Research Site
Vladivostok, Primorskiy Krai, Russian Federation
Research Site
Yakutsk, Republic of Sakha, Russian Federation
Research Site
Kazan, Resp. of Tatarstan, Russian Federation
Research Site
Arkhangelsk, Russian Federation
Research Site
Belgorod, Russian Federation
Research Site
Blagoveschensk, Russian Federation
Research Site
Chita, Russian Federation
Research Site
Engels, Russian Federation
Research Site
Irkutsk, Russian Federation
Research Site
Kemerovo, Russian Federation
Research Site
Khimki, Russian Federation
Research Site
Moscow, Russian Federation
Research Site
Nizhniy Novgorod, Russian Federation
Research Site
Novosibirsk, Russian Federation
Research Site
Obninsk, Russian Federation
Research Site
Omsk, Russian Federation
Research Site
Orel, Russian Federation
Research Site
Perm, Russian Federation
Research Site
Pyatigorsk, Russian Federation
Research Site
Samara, Russian Federation
Research Site
St. Petersburg, Russian Federation
Research Site
Tomsk, Russian Federation
Research Site
Tula, Russian Federation
Research Site
Volgograd, Russian Federation
Research Site
Yuzno-Sakhalinsk, Russian Federation
Research Site
Zhukovsky, Russian Federation
Sponsors and Collaborators
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01069835     History of Changes
Other Study ID Numbers: NIS-ORU-IRE-2009/1
First Posted: February 17, 2010    Key Record Dates
Last Update Posted: May 19, 2015
Last Verified: May 2015

Keywords provided by AstraZeneca:
Non small cell lung cancer
EGFR mutation

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms