Epidemiological Study to Describe Non Small Cell Lung Cancer (NSCLC) Clinical Management Patterns in Central Eastern Europe and Russia (Lung-EPICLIN) (EPICLIN)
May 18, 2015 updated by: AstraZeneca
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
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
840
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arkhangelsk, Russian Federation
- Research Site
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Belgorod, Russian Federation
- Research Site
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Blagoveschensk, Russian Federation
- Research Site
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Chita, Russian Federation
- Research Site
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Engels, Russian Federation
- Research Site
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Irkutsk, Russian Federation
- Research Site
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Kemerovo, Russian Federation
- Research Site
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Khimki, Russian Federation
- Research Site
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Moscow, Russian Federation
- Research Site
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Nizhniy Novgorod, Russian Federation
- Research Site
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Novosibirsk, Russian Federation
- Research Site
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Obninsk, Russian Federation
- Research Site
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Omsk, Russian Federation
- Research Site
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Orel, Russian Federation
- Research Site
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Perm, Russian Federation
- Research Site
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Pyatigorsk, Russian Federation
- Research Site
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Samara, Russian Federation
- Research Site
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St. Petersburg, Russian Federation
- Research Site
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Tomsk, Russian Federation
- Research Site
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Tula, Russian Federation
- Research Site
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Volgograd, Russian Federation
- Research Site
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Yuzno-Sakhalinsk, Russian Federation
- Research Site
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Zhukovsky, Russian Federation
- Research Site
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Altaiskiy Krai
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Barnaul, Altaiskiy Krai, Russian Federation
- Research Site
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EAO
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Birobidzhan, EAO, Russian Federation
- Research Site
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Khabarovskiy Krai
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Khabarovsk, Khabarovskiy Krai, Russian Federation
- Research Site
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Khanty-Mansyiskyi AO
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Khanty-Mansyisk, Khanty-Mansyiskyi AO, Russian Federation
- Research Site
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Krasnodarskiy Krai
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Krasnodar, Krasnodarskiy Krai, Russian Federation
- Research Site
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Primorskiy Krai
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Vladivostok, Primorskiy Krai, Russian Federation
- Research Site
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Republic of Sakha
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Yakutsk, Republic of Sakha, Russian Federation
- Research Site
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Resp. of Tatarstan
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Kazan, Resp. of Tatarstan, Russian Federation
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Cancer patients from Oncological Dispensaries and Cancer Research Institutes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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1
Non-small cell lung cancer patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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24 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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To detect differences in clinical outcomes and related factors among countries
Time Frame: 24 months
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24 months
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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
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24 months
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To identify factors associated with the different levels of functional status and quality of life
Time Frame: 24 months
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24 months
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To compare the use of health care resources among countries
Time Frame: 24 months
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24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2010
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
March 1, 2012
Study Registration Dates
First Submitted
February 15, 2010
First Submitted That Met QC Criteria
February 16, 2010
First Posted (Estimate)
February 17, 2010
Study Record Updates
Last Update Posted (Estimate)
May 19, 2015
Last Update Submitted That Met QC Criteria
May 18, 2015
Last Verified
May 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIS-ORU-IRE-2009/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.