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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).

NCT ID: NCT01153399

Last Updated: 2015-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

589 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-31

Study Completion Date

2014-12-31

Brief Summary

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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).

Detailed Description

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Conditions

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Non Small Cell Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients with Non Small Cell Lung Cancer, visiting hospital oncology clinics

No interventions assigned to this group

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Panagiotis Pontikis

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Athens, Athens, Greece

Site Status

Research Site

Crete, Crete, Greece

Site Status

Research Site

Ioannina, Ioannina, Greece

Site Status

Research Site

Kavala, Kavala, Greece

Site Status

Research Site

Larissa, Larisa, Greece

Site Status

Research Site

Pátrai, Patra, Greece

Site Status

Research Site

Ptolemaida, Ptolemaida, Greece

Site Status

Research Site

Thessaloniki, Thessaloniki, Greece

Site Status

Research Site

Volos, Volos, Greece

Site Status

Countries

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Greece

Related Links

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http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=998&filename=CSR_Synopsis_NIS-OGR-DUM-2010_1_version_1_0_abstract.pdf

CSR\_Synopsis\_NIS-OGR-DUM-2010\_1.pdf

Other Identifiers

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NIS-OGR-DUM-2010/1

Identifier Type: -

Identifier Source: org_study_id