We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Non-interventional Study (NIS) Registry for the Epidemiological and Scientific Evaluation of Epidermal Growth Factor Receptor (EGFR) Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) (Stage IIIB/IV Non-small Cell Lung Cancer). (REASON)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01153399
First Posted: June 30, 2010
Last Update Posted: November 20, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
June 25, 2010
June 30, 2010
November 20, 2015
October 2010
December 2014   (Final data collection date for primary outcome measure)
  • Epidemiological data on EGFR mutation status (M+, M-) in a population of predominantly Caucasian ethnicity [ Time Frame: Up to 2,5 years ]
  • Clinico-pathological characteristics according to mutation status [ Time Frame: Up to 2,5 years ]
  • Epidemiological data on EGFR mutation status (M+, M-) in a population of predominantly Caucasian ethnicity [ Time Frame: End of recruitment (estimated timeframe : 2.5 years) ]
  • Clinico-pathological characteristics according to mutation status [ Time Frame: End of recruitment (estimated timeframe : 2.5 years) ]
Complete list of historical versions of study NCT01153399 on ClinicalTrials.gov Archive Site
  • Pharmacoeconomic data (resource use) associated with the diagnosis and treatment of EGFR M+ patients [ Time Frame: Up to 3,5 years ]
  • Real-life data on 1st-line treatment decisions in EGFR M+ and M-/Mx(mutation status not evaluable) patients [ Time Frame: Up to 2,5 years ]
  • Clinical outcome data under real life clinical practice in all EGFR M+ patients up to disease progression (PFS, OS, DCR) [ Time Frame: Up to 3,5 years ]
  • Pharmacoeconomic data (resource use) associated with the diagnosis and treatment of EGFR M+ patients [ Time Frame: 1 year after LSI (estimated timeframe : 3.5 years) ]
  • Real-life data on 1st-line treatment decisions in EGFR M+ and M-/Mx patients [ Time Frame: End of recruitment (estimated timeframe : 2.5 years) ]
  • Clinical outcome data under real life clinical practice in all EGFR M+ patients up to disease progression (PFS, OS, DCR) [ Time Frame: 1 year after LSI (estimated timeframe : 3.5 years) ]
Not Provided
Not Provided
 
A Non-interventional Study (NIS) Registry for the Epidemiological and Scientific Evaluation of Epidermal Growth Factor Receptor (EGFR) Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic Non Small Cell Lung Cancer (NSCLC) (Stage IIIB/IV Non-small Cell Lung Cancer).
An NIS Registry for the Epidemiological and Scientific Evaluation of EGFR Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic NSCLC (Stage IIIB/IV Non-small Cell Lung Cancer)-REASON STUDY.
The primary objective of the study is to collect epidemiological data on EGFR mutation status [M+(mutation positive), M-(mutation negative)] in a population of predominantly Caucasian ethnicity, and to correlate EGFR mutation status with clinico-pathological characteristics (e.g. smoking status, sex, histology, etc). In particular, the study will aim to determine the frequency of EGFR M+ lung cancers in patients with clinico-pathological characteristics that are not commonly associated with EGFR mutation positivity (i.e., smokers, men, and non-adenocarcinoma).
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
Patients with Non Small Cell Lung Cancer
Non Small Cell Lung Cancer
Not Provided
1
Patients with Non Small Cell Lung Cancer, visiting hospital oncology clinics
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
589
December 2014
December 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Signed written informed consent.
  2. Female or male aged 18 years or above.
  3. Histologically confirmed locally advanced or metastatic NSCLC (stage IIIB/IV).
  4. Patients receiving 1st-line treatment for IIIB/IV NSCLC.
  5. Patients with known EGFR mutation status (i.e. patients must be either EGFR M+, EGFR M- or EGFR Mx).
  6. Tumour not amenable to curative surgery or radiotherapy.

Exclusion Criteria:

1. Mixed histology of small cell and non-small cell lung cancer.

Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
Greece
 
 
NCT01153399
NIS-OGR-DUM-2010/1
No
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: Panagiotis Pontikis AstraZeneca
AstraZeneca
November 2015