Spanish REASON: 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)

• Sponsor: AstraZeneca (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01081496
• Collaborator: (none)
• Enrollment: 1,000
• Locations: 24
• Duration (Months): 11.1
• Patients Per Site: 41.7
• Patients Per Site Per Month: 3.8

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Non Small Cell Lung Cancer

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• 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)
• Study Start Date: Mar 1, 2010
• Actual Primary Completion Date: Aug 1, 2010
• Actual Study Completion Date: Feb 1, 2011

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. 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 []

2. To describe different EGFR mutation methods used in Spain and testing turn around time associated []

3. 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

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Research Site	Santiago de Compostela	A Coruna	Spain
2	Research Site	Elche	Alicante	Spain
3	Research Site	Oviedo	Asturias	Spain
4	Research Site	Pamplona	Navarra	Spain
5	Research Site	Vigo	Pontevedra	Spain
6	Research Site	Reus	Tarragona	Spain
7	Research Site	Albacete		Spain
8	Research Site	Alicante		Spain
9	Research Site	Barcelona		Spain
10	Research Site	Caceres		Spain
11	Research Site	Cordoba		Spain
12	Research Site	Girona		Spain
13	Research Site	Granada		Spain
14	Research Site	Jaen		Spain
15	Research Site	Lugo		Spain
16	Research Site	Madrid		Spain
17	Research Site	Malaga		Spain
18	Research Site	Murcia		Spain
19	Research Site	Pontevedra		Spain
20	Research Site	Salamanca		Spain
21	Research Site	Santander		Spain
22	Research Site	Sevilla		Spain
23	Research Site	Valencia		Spain
24	Research Site	Zaragoza		Spain

Sponsors and Collaborators

• AstraZeneca

Investigators

• Study Director: Carmen Gonzalez Arenas, Medical Department. Mediclin-AstraZeneca. Spain

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01081496
• Other Study ID Numbers: NIS-OES-DUM-2009/1
• First Posted: Mar 5, 2010
• Last Update Posted: Mar 16, 2011
• Last Verified: Mar 1, 2011

• Keywords provided by , ,: 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: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Mar 16, 2011