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:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01069835
First received: February 15, 2010
Last updated: February 4, 2013
Last verified: February 2013
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 20, 2014