Epidemiological Study to Describe Non Small Cell Lung Cancer (NSCLC) Clinical Management Patterns in Central Eastern Europe and Russia (Lung-EPICLIN)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01069835
First received: February 15, 2010
Last updated: February 4, 2013
Last verified: February 2013
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Purpose
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 |
|---|
|
Non Small Cell Lung Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Epidemiological Study to Describe NSCLC Clinical Management Patterns in Central Eastern Europe and Russia. Lung-EPICLIN |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Biospecimen Retention: Samples With DNA
Paraffin embedded tumour tissue samples
| Enrollment: | 840 |
| Study Start Date: | February 2010 |
| Study Completion Date: | March 2012 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Non-small cell lung cancer patients
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Cancer patients from Oncological Dispensaries and Cancer Research Institutes
Criteria
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01069835
Locations
| 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
AstraZeneca
More Information
No publications provided
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01069835 History of Changes |
| Other Study ID Numbers: | NIS-ORU-IRE-2009/1 |
| Study First Received: | February 15, 2010 |
| Last Updated: | February 4, 2013 |
| Health Authority: | Russia: Ethics Committee |
Keywords provided by AstraZeneca:
|
Non small cell lung cancer EGFR mutation NSCLC |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms |
Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 23, 2013