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
1 other identifier
observational
1,000
1 country
24
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2010
Shorter than P25 for all trials
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 1, 2010
CompletedStudy Start
First participant enrolled
March 1, 2010
CompletedFirst Posted
Study publicly available on registry
March 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedMarch 16, 2011
March 1, 2011
5 months
March 1, 2010
March 15, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Secondary Outcomes (3)
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
To describe different EGFR mutation methods used in Spain and testing turn around time associated
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)
Eligibility Criteria
To be recruited by Oncologist
You may qualify if:
- Signed written informed consent
- Histologically confirmed locally advanced or metastatic NSCLC (stage IIIB/IV)
You may not qualify if:
- Mixed histology of small cell and non-small cell lung cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (24)
Research Site
Santiago de Compostela, A Coruna, Spain
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Albacete, Albacete, Spain
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Alicante, Alicante, Spain
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Elche, Alicante, Spain
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Barcelona, Barcelona, Spain
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Cáceres, Caceres, Spain
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Santander, Cantabria, Spain
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Córdoba, Cordoba, Spain
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Girona, Girona, Spain
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Granada, Granada, Spain
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Jaén, Jaen, Spain
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Lugo, Lugo, Spain
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Madrid, Madrid, Spain
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Málaga, Malaga, Spain
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Murcia, Murcia, Spain
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Pamplona, Navarre, Spain
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Pontevedra, Pontevedra, Spain
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Vigo, Pontevedra, Spain
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Oviedo, Principality of Asturias, Spain
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Salamanca, Salamanca, Spain
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Seville, Sevilla, Spain
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Reus, Tarragona, Spain
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Valencia, Valencia, Spain
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Zaragoza, Zaragoza, Spain
Related Publications (1)
Esteban E, Majem M, Martinez Aguillo M, Martinez Banaclocha N, Domine M, Gomez Aldaravi L, Juan O, Cajal R, Gonzalez Arenas MC, Provencio M. Prevalence of EGFR mutations in newly diagnosed locally advanced or metastatic non-small cell lung cancer Spanish patients and its association with histological subtypes and clinical features: The Spanish REASON study. Cancer Epidemiol. 2015 Jun;39(3):291-7. doi: 10.1016/j.canep.2015.02.003. Epub 2015 Mar 9.
PMID: 25766256DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Carmen Gonzalez Arenas
Medical Department. Mediclin-AstraZeneca. Spain
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 1, 2010
First Posted
March 5, 2010
Study Start
March 1, 2010
Primary Completion
August 1, 2010
Study Completion
February 1, 2011
Last Updated
March 16, 2011
Record last verified: 2011-03