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Retrospective Study in a NSCLC M+ p

NCT ID: NCT01795352

Last Updated: 2013-10-30

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

187 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-10-31

Brief Summary

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This is a national, multicentre, non-interventional, retrospective study to be carried out in the oncology settings of approximately 15-20 Spanish hospitals.

At each participant hospital, all patients recently diagnosed with advanced EGFR mutated NSCLC (both newly or with recurrent disease , without previous treatment for metastatic disease) from April 2010 to December 2011 will be included as study population. Information about the follow-up of the patients during a minimum of 12 months after diagnosis will be collected.

Detailed Description

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Observational retrospective study to describe the management of advanced or metastatic EGFR mutated non-small cell lung cancer patients in Spain

Conditions

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EGFR Mutated Non-small Cell Lung Cancer Patients

Keywords

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EGFR, lung cancer, mutated

Study Design

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Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Histologically or cytologically confirmed newly locally advanced or metastatic NSCLC (stage IIIB/IV)
* Confirmed EGFR mutation by a validated test
* Availability of medical record

Exclusion Criteria

* Participating on a blinded randomized clinical trial at any time during the study period
* Pregnant women (due to they do not reflect daily clinical practice)
Minimum Eligible Age

18 Years

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

Locations

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Research Site

Barcelona, Barcelona, Spain

Site Status

Research Site

Córdoba, Cordoba, Spain

Site Status

Research Site

Donostia / San Sebastian, Donostia, Spain

Site Status

Research Site

Granada, Granada, Spain

Site Status

Research Site

León, Leon, Spain

Site Status

Research Site

Madrid, Madrid, Spain

Site Status

Research Site

Málaga, Malaga, Spain

Site Status

Research Site

Navarra, Navarre, Spain

Site Status

Research Site

Seville, Sevilla, Spain

Site Status

Research Site

Toledo, Toledo, Spain

Site Status

Research Site

Valencia, Valencia, Spain

Site Status

Research Site

Zaragoza, Zaragoza, Spain

Site Status

Countries

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Spain

Other Identifiers

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NIS-OES-XXX-2012/1

Identifier Type: -

Identifier Source: org_study_id