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Trial Title:
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
Condition:
Non-Small Cell Lung Cancer
Conditions: Official terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Conditions: Keywords:
EGFR mutations
EGFR inhibitor
erlotinib
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Summary:
Recently it has been suggested that specific mutations in the EGFR gene in lung cancer
patients is associated with response to a novel drug targeting the EGF system. Recent
research also indicates that there is a possible association to the degree of
aggressiveness of the disease.
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:
Aim:
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.
Criteria for eligibility:
Study pop:
Patients with non-small cell lung cancer who will start treatment with erlotinib
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Patients who are starting treatment with erlotinib and who has who has signed the
informed consent.
Exclusion Criteria:
- None
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
department of oncology, University Hospital of Aarhus, Nørrebrogade 44
Address:
City:
8000 Aarhus
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Britta Weber, MD
Phone:
+4589493333
Email:
doctorweber@stofanet.dk
Contact backup:
Last name:
Peter meldgaard, PhD MD
Phone:
+4589493333
Email:
peter.meldgaard@dadlnet.dk
Investigator:
Last name:
Peter meldgaard, PhD MD
Email:
Principal Investigator
Start date:
May 2008
Completion date:
May 2011
Lead sponsor:
Agency:
Aarhus University Hospital
Agency class:
Other
Collaborator:
Agency:
University of Aarhus
Agency class:
Other
Collaborator:
Agency:
The Ministry of Science, Technology and Innovation, Denmark
Agency class:
Other
Collaborator:
Agency:
Hoffmann-La Roche
Agency class:
Industry
Source:
Aarhus University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00815971
