Non Small Cell Lung Cancer Clinical Trial
— EPICLINOfficial title:
Epidemiological Study to Describe NSCLC Clinical Management Patterns in Central Eastern Europe and Russia. Lung-EPICLIN
| Verified date | May 2015 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Russia: Ethics Committee |
| Study type | Observational |
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
| Status | Completed |
| Enrollment | 840 |
| Est. completion date | March 2012 |
| Est. primary completion date | March 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Russian Federation | Research Site | Arkhangelsk | |
| Russian Federation | Research Site | Barnaul | Altaiskiy Krai |
| Russian Federation | Research Site | Belgorod | |
| Russian Federation | Research Site | Birobidzhan | EAO |
| Russian Federation | Research Site | Blagoveschensk | |
| Russian Federation | Research Site | Chita | |
| Russian Federation | Research Site | Engels | |
| Russian Federation | Research Site | Irkutsk | |
| Russian Federation | Research Site | Kazan | Resp. of Tatarstan |
| Russian Federation | Research Site | Kemerovo | |
| Russian Federation | Research Site | Khabarovsk | Khabarovskiy Krai |
| Russian Federation | Research Site | Khanty-Mansyisk | Khanty-Mansyiskyi AO |
| Russian Federation | Research Site | Khimki | |
| Russian Federation | Research Site | Krasnodar | Krasnodarskiy Krai |
| 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 | Vladivostok | Primorskiy Krai |
| Russian Federation | Research Site | Volgograd | |
| Russian Federation | Research Site | Yakutsk | Republic of Sakha |
| Russian Federation | Research Site | Yuzno-Sakhalinsk | |
| Russian Federation | Research Site | Zhukovsky |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No | |
| Secondary | To detect differences in clinical outcomes and related factors among countries | 24 months | No | |
| Secondary | 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 | No | |
| Secondary | To identify factors associated with the different levels of functional status and quality of life | 24 months | No | |
| Secondary | To compare the use of health care resources among countries | 24 months | No |
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