Mutations in the Epidermal Growth Factor Receptor(EGFR) Gene in Non-Small Cell Lung Carcinoma (NSCLC) and the Relation to Response of Treatment With Erlotinib
NCT ID: NCT00815971
Last Updated: 2008-12-31
Study Results
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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UNKNOWN
300 participants
OBSERVATIONAL
2008-05-31
2011-05-31
Brief Summary
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The importance of these mutations is controversial, because the data are based on small studies with highly selected patients.
In this project the investigators want to study the types and frequencies of EGFR mutations in both untreated and treated patients in a systematic manner and relate this to survival.
The thorough registration of patient data in DK enables us to create a strong The investigators expect this knowledge to be of greatest importance for future rational use of drugs targeting the EGF receptors.
Detailed Description
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1. To establish a method for identifying the mutations in the EGFR gene in small clinical samples from lung cancer patients.
2. In a retrospective study(n=500) relate survival to the frequency and types of mutations in the EGFR gene in a Danish population of patients with advanced, inoperable non small cell lung cancer (NSCLC) diagnosed prior to the introduction of treatment directed towards EGFR.
3. In a prospective study (n=300), to identify the mutations in the EGFR gene in patients treated with erlotinib, a tyrosine kinase inhibitor targeting the EGFR. Presence of mutations will be related to the expression of other parts of the EGF system, to mutations in the gene coding for K-RAS and to treatment response.
Conditions
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Keywords
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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NSCLC
Patients with non-small cell lung cancer carcinoma treated with erlotinib
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Aarhus
OTHER
The Ministry of Science, Technology and Innovation, Denmark
OTHER_GOV
Hoffmann-La Roche
INDUSTRY
Aarhus University Hospital
OTHER
Responsible Party
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Aarhus University Hospital
Principal Investigators
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Peter Meldgaard, PhD MD
Role: PRINCIPAL_INVESTIGATOR
Aarhus University Hospital
Locations
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department of oncology, University Hospital of Aarhus, Nørrebrogade 44
8000 Aarhus, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Britta Weber, MD
Role: primary
Peter meldgaard, PhD MD
Role: backup
References
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Sorensen BS, Wu L, Wei W, Tsai J, Weber B, Nexo E, Meldgaard P. Monitoring of epidermal growth factor receptor tyrosine kinase inhibitor-sensitizing and resistance mutations in the plasma DNA of patients with advanced non-small cell lung cancer during treatment with erlotinib. Cancer. 2014 Dec 15;120(24):3896-901. doi: 10.1002/cncr.28964. Epub 2014 Aug 7.
Weber B, Meldgaard P, Hager H, Wu L, Wei W, Tsai J, Khalil A, Nexo E, Sorensen BS. Detection of EGFR mutations in plasma and biopsies from non-small cell lung cancer patients by allele-specific PCR assays. BMC Cancer. 2014 Apr 28;14:294. doi: 10.1186/1471-2407-14-294.
Other Identifiers
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M-20080012 (ethics committee)
Identifier Type: -
Identifier Source: org_study_id