Epidemiological Study to Describe Non Small Cell Lung Cancer (NSCLC) Clinical Management Patterns in Central Eastern Europe and Russia (Lung-EPICLIN)
EPICLIN
1 other identifier
observational
840
1 country
31
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2010
Typical duration for all trials
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 15, 2010
CompletedFirst Posted
Study publicly available on registry
February 17, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedMay 19, 2015
May 1, 2015
1.1 years
February 15, 2010
May 18, 2015
Conditions
Keywords
Outcome Measures
Primary 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 Central Eastern European countries and Russia
24 months
Secondary Outcomes (4)
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
Study Arms (1)
1
Non-small cell lung cancer patients
Eligibility Criteria
Cancer patients from Oncological Dispensaries and Cancer Research Institutes
You may qualify if:
- 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.
You may not qualify if:
- Mixed histology of small cell and non-small cell lung cancer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (31)
Research Site
Barnaul, Altaiskiy Krai, Russia
Research Site
Birobidzhan, EAO, Russia
Research Site
Khabarovsk, Khabarovskiy Krai, Russia
Research Site
Khanty-Mansyisk, Khanty-Mansyiskyi AO, Russia
Research Site
Krasnodar, Krasnodarskiy Krai, Russia
Research Site
Vladivostok, Primorskiy Krai, Russia
Research Site
Kazan', Resp. of Tatarstan, Russia
Research Site
Yakutsk, Sakha, Russia
Research Site
Arkhangelsk, Russia
Research Site
Belgorod, Russia
Research Site
Blagoveshchensk, Russia
Research Site
Chita, Russia
Research Site
Engel's, Russia
Research Site
Irkutsk, Russia
Research Site
Kemerovo, Russia
Research Site
Khimki, Russia
Research Site
Moscow, Russia
Research Site
Nizhny Novgorod, Russia
Research Site
Novosibirsk, Russia
Research Site
Obninsk, Russia
Research Site
Omsk, Russia
Research Site
Oryol, Russia
Research Site
Perm, Russia
Research Site
Pyatigorsk, Russia
Research Site
Saint Petersburg, Russia
Research Site
Samara, Russia
Research Site
Tomsk, Russia
Research Site
Tula, Russia
Research Site
Volgograd, Russia
Research Site
Yuzno-Sakhalinsk, Russia
Research Site
Zhukovsky, Russia
Related Publications (1)
Tjulandin S, Imyanitov E, Moiseyenko V, Ponomarenko D, Gurina L, Koroleva I, Karaseva V. Prospective cohort study of clinical characteristics and management patterns for patients with non-small-cell lung cancer in the Russian Federation: EPICLIN-Lung. Curr Med Res Opin. 2015 Jun;31(6):1117-27. doi: 10.1185/03007995.2015.1036015. Epub 2015 May 8.
PMID: 25867537DERIVED
Related Links
Biospecimen
Paraffin embedded tumour tissue samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2010
First Posted
February 17, 2010
Study Start
February 1, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2012
Last Updated
May 19, 2015
Record last verified: 2015-05