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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 is currently recruiting participants.
Verified April 2013 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01153399
First received: June 25, 2010
Last updated: April 12, 2013
Last verified: April 2013
History of Changes
  Purpose

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).


Condition
Non Small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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.

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Epidemiological data on EGFR mutation status (M+, M-) in a population of predominantly Caucasian ethnicity [ Time Frame: Up to 2,5 years ] [ Designated as safety issue: No ]
  • Clinico-pathological characteristics according to mutation status [ Time Frame: Up to 2,5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pharmacoeconomic data (resource use) associated with the diagnosis and treatment of EGFR M+ patients [ Time Frame: Up to 3,5 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 428
Study Start Date: October 2010
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with Non Small Cell Lung Cancer, visiting hospital oncology clinics

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with Non Small Cell Lung Cancer

Criteria

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01153399

Contacts
Contact: AstraZeneca Greece Clinical Study Information 30 2106871500

Locations
Greece
Research Site Recruiting
Athens, Greece
Research Site Recruiting
Crete, Greece
Research Site Not yet recruiting
Ioannina, Greece
Research Site Active, not recruiting
Kavala, Greece
Research Site Recruiting
Larisa, Greece
Research Site Recruiting
Patra, Greece
Research Site Not yet recruiting
Ptolemaida, Greece
Research Site Recruiting
Thessaloniki, Greece
Research Site Recruiting
Volos, Greece
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Panagiotis Pontikis AstraZeneca
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01153399     History of Changes
Other Study ID Numbers: NIS-OGR-DUM-2010/1
Study First Received: June 25, 2010
Last Updated: April 12, 2013
Health Authority: Greece: National Organization of Medicines

Keywords provided by AstraZeneca:
Non Small Cell Lung Cancer
EGFR mutations

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 19, 2013