Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 20 of 1574 for:    EGFR

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:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01081496
First received: March 1, 2010
Last updated: March 15, 2011
Last verified: March 2011
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Research Site
Oviedo, Asturias, Spain
Research Site
Pamplona, Navarra, Spain
Research Site
Vigo, Pontevedra, Spain
Research Site
Reus, Tarragona, Spain
Research Site
Albacete, Spain
Research Site
Alicante, Spain
Research Site
Barcelona, Spain
Research Site
Caceres, Spain
Research Site
Cordoba, Spain
Research Site
Girona, Spain
Research Site
Granada, Spain
Research Site
Jaen, Spain
Research Site
Lugo, Spain
Research Site
Madrid, Spain
Research Site
Malaga, Spain
Research Site
Murcia, Spain
Research Site
Pontevedra, Spain
Research Site
Salamanca, Spain
Research Site
Santander, Spain
Research Site
Sevilla, Spain
Research Site
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
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2014