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)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01081496
First received: March 1, 2010
Last updated: March 15, 2011
Last verified: March 2011
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Purpose
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).
| Condition |
|---|
|
Non Small Cell Lung Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | 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) |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- 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). [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 [ Designated as safety issue: No ]
- To describe different EGFR mutation methods used in Spain and testing turn around time associated [ Designated as safety issue: No ]
- 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) [ Designated as safety issue: No ]
| Estimated Enrollment: | 1000 |
| Study Start Date: | March 2010 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
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
To be recruited by Oncologist
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01081496
Locations
| Spain | |
| Research Site | |
| Santiago de Compostela, A Coruna, Spain | |
| Research Site | |
| Elche, Alicante, Spain | |
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| Oviedo, Asturias, Spain | |
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| Pamplona, Navarra, Spain | |
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| Vigo, Pontevedra, Spain | |
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| Reus, Tarragona, Spain | |
| Research Site | |
| Albacete, Spain | |
| Research Site | |
| Alicante, Spain | |
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| Barcelona, Spain | |
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| Caceres, Spain | |
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| Cordoba, Spain | |
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| Girona, Spain | |
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| Granada, Spain | |
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| Jaen, Spain | |
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| Lugo, Spain | |
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| Madrid, Spain | |
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| Malaga, Spain | |
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| Murcia, Spain | |
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| Pontevedra, Spain | |
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| Salamanca, Spain | |
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| Santander, Spain | |
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| Sevilla, Spain | |
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| Valencia, Spain | |
| Research Site | |
| Zaragoza, Spain | |
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Carmen Gonzalez Arenas | Medical Department. Mediclin-AstraZeneca. Spain |
More Information
No publications provided
| Responsible Party: | MC MD, AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT01081496 History of Changes |
| Other Study ID Numbers: | NIS-OES-DUM-2009/1 |
| Study First Received: | March 1, 2010 |
| Last Updated: | March 15, 2011 |
| Health Authority: | Spain: Ethics Committee Spain: Spanish Agency of Medicines |
Keywords provided by AstraZeneca:
|
EGFR mutation, Non-small cell lung carcinoma, Spain Evaluate the prevalence of EGFR mutation status in patients with newly diagnosed locally advanced or metastatic 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