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Trial record 1 of 1 for:    NCT00997230
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Epidemiological and Scientific Evaluation of EGFR Mutation Status in Patients With Newly Diagnosed Locally Advanced or m (REASON)

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ClinicalTrials.gov Identifier: NCT00997230
Recruitment Status : Completed
First Posted : October 19, 2009
Last Update Posted : October 28, 2013
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
The primary objective of the study is to collect epidemiological data on EGFR mutation status (M+, M-) in a population of predominantly Caucasian ethnicity and to correlate EGFR mutation status with clinico-pathological characteristics (e.g. smoking status, sex, histology, etc). In particular, the study will aim to determine the frequency of EGFR M+ lung cancers in patients with clinico-pathological characteristics that are not commonly associated with EGFR mutation positivity (i.e., smokers, men, and non-adenocarcinoma).

Condition or disease
Newly Diagnosed Locally Advanced or Metastatic Non-small Cell Lung Cancer

Detailed Description:
An NIS Registry for the Epidemiological and Scientific evaluation of EGFR mutation status in patients with newly diagnosed locally advanced or metastatic NSCLC (stage IIIB/IV non-small cell lung cancer)
Study Design
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Study Type : Observational
Actual Enrollment : 4243 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: An NIS Registry for the Epidemiological and Scientific Evaluation of EGFR Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic Non-small Cell Lung Cancer (Stage IIIB/IV Non-small Cell Lung Cancer)
Study Start Date : September 2009
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. The primary objective of the study is to collect epidemiological data on EGFR mutation status (M+, M-) in a population of predominantly Caucasian ethnicity and to correlate EGFR mutation status with clinico-pathological characteristics [ Time Frame: Days 1-10 ]

Secondary Outcome Measures :
  1. To collect real-life clinical outcome data in all EGFR M+ patients up to and including progression.To collect real-life pharmacoeconomic data (resource use) associated with the diagnosis and treatment of EGFR M+ patients. [ Time Frame: Study Days 21-30 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
clinical setting
Criteria
Histologically confirmed locally advanced or metastatic NSCLC (stage IIIB/IV). Mixed histology of small cell and non-small cell lung cancer
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00997230


Locations
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Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Prof. Dr. H. Brasch AstraZeneca Germany
Principal Investigator: PD Dr. med. Wolfgang Schutte 06120 Halle-Dolau, Germany
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00997230    
Other Study ID Numbers: NIS-ODE-DUM-2009/1
First Posted: October 19, 2009    Key Record Dates
Last Update Posted: October 28, 2013
Last Verified: October 2013
Keywords provided by AstraZeneca:
EGFR mutation ,newly diagnosed NSCLC, locally advanced or metastatic NSCLC
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms