- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01081496
Epidemiological Study to Evaluate the Prevalence of Epidermal Growth Factor Receptor (EGFR) Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) (Spanish REASON)
March 15, 2011 updated by: AstraZeneca
Epidemiological Study to Evaluate the Prevalence of EGFR Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic NSCLC (Stage IIIB/IV Non-small Cell Lung Cancer)
To estimate the prevalence of EGFR mutation in a representative sample of patients with newly diagnosed stage IIIB/IV NSCLC in Spain (predominantly Caucasian ethnicity).
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Anticipated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Albacete, Spain
- Research Site
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Alicante, Spain
- Research Site
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Barcelona, Spain
- Research Site
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Caceres, Spain
- Research Site
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Cordoba, Spain
- Research Site
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Girona, Spain
- Research Site
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Granada, Spain
- Research Site
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Jaen, Spain
- Research Site
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Lugo, Spain
- Research Site
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Madrid, Spain
- Research Site
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Malaga, Spain
- Research Site
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Murcia, Spain
- Research Site
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Pontevedra, Spain
- Research Site
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Salamanca, Spain
- Research Site
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Santander, Spain
- Research Site
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Sevilla, Spain
- Research Site
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Valencia, Spain
- Research Site
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Zaragoza, Spain
- Research Site
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A Coruna
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Santiago de Compostela, A Coruna, Spain
- Research Site
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Alicante
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Elche, Alicante, Spain
- Research Site
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Asturias
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Oviedo, Asturias, Spain
- Research Site
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Navarra
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Pamplona, Navarra, Spain
- Research Site
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Pontevedra
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Vigo, Pontevedra, Spain
- Research Site
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Tarragona
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Reus, Tarragona, Spain
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
To be recruited by Oncologist
Description
Inclusion Criteria:
- Signed written informed consent
- Histologically confirmed locally advanced or metastatic NSCLC (stage IIIB/IV)
Exclusion Criteria:
- Mixed histology of small cell and non-small cell lung cancer
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To estimate the prevalence of EGFR mutation in a representative sample of patients with newly diagnosed stage IIIB/IV NSCLC in Spain (predominantly Caucasian ethnicity).
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Secondary Outcome Measures
Outcome Measure |
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Correlate EGFR mutation status with clinico-pathological characteristics. The study will aim to determine the prevalence of EGFR M+ lung cancers in patients with clinico-pathological characteristics not commonly associated with EGFR mutation positivity
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To describe different EGFR mutation methods used in Spain and testing turn around time associated
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To determine the % of confirmed stage IIIB/IV NSCLC patients who cannot be tested for EGFR mutation and the reasons for not testing (% of EGFR Mnt)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Carmen Gonzalez Arenas, Medical Department. Mediclin-AstraZeneca. Spain
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2010
Primary Completion (Actual)
August 1, 2010
Study Completion (Actual)
February 1, 2011
Study Registration Dates
First Submitted
March 1, 2010
First Submitted That Met QC Criteria
March 4, 2010
First Posted (Estimate)
March 5, 2010
Study Record Updates
Last Update Posted (Estimate)
March 16, 2011
Last Update Submitted That Met QC Criteria
March 15, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIS-OES-DUM-2009/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Karen KellyBristol-Myers Squibb; National Cancer Institute (NCI); TransgeneCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung CancerUnited States
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Stanford UniversityAstraZenecaRecruitingNon-small Cell Lung Cancer Stage III | Non-small Cell Lung Cancer | Non-small Cell Lung Cancer Stage I | Non-small Cell Lung Cancer Stage IIUnited States
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Ohio State University Comprehensive Cancer CenterActive, not recruitingStage IIIA Non-small Cell Lung Cancer | Stage IIIB Non-small Cell Lung Cancer | Recurrent Non-small Cell Lung Cancer | Stage IIA Non-small Cell Lung Cancer | Stage IIB Non-small Cell Lung CancerUnited States