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Pathomolecular Analysis of Rare EGFR Mutations in Advanced NSCLC

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.
 
ClinicalTrials.gov Identifier: NCT01215474
Recruitment Status : Completed
First Posted : October 6, 2010
Last Update Posted : June 16, 2011
Sponsor:
Collaborators:
AstraZeneca
Charite University, Berlin, Germany
Information provided by:
Provitro GmbH

Study Description
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Brief Summary:
While current mutational analyses comprise exons 19 and 21 in which the majority of EGFR-mutations occur, this study aims at investigating the relevance of exon 18 and 20 mutations. Therefore, the investigators analyse 500 routine tumor samples with respect to the above mentioned exons and correlate the results to the clinical outcome. This approach will enable us to potentially identify patients that might in the future benefit from targeted therapy (EGFR-inhibition).

Condition or disease
Mutations in Exons 18 to 21

Study Design
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Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Groups and Cohorts
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Group/Cohort
NSCLC Stadium III-IV


Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who were biopsied and/or received surgery for NSCLC diagnostics
Criteria

Inclusion Criteria:

  • NSCLC Stadium III-IV

Exclusion Criteria:

  • no NSCLC or different stadium
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01215474


Locations
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Germany
Institute of Pathology, Charité University Medicine Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Provitro GmbH
AstraZeneca
Charite University, Berlin, Germany
More Information
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ClinicalTrials.gov Identifier: NCT01215474    
Other Study ID Numbers: AZ-NSCLC 18+
First Posted: October 6, 2010    Key Record Dates
Last Update Posted: June 16, 2011
Last Verified: October 2010