Ignite Creation Date:
2024-05-05 @ 9:07 PM
Last Modification Date:
2024-10-26 @ 9:59 AM
Study NCT ID:
NCT00815971
Status:
UNKNOWN
Last Update Posted:
2008-12-31
First Post:
2008-12-30
Brief Title:
Mutations in the Epidermal Growth Factor ReceptorEGFR Gene in Non-Small Cell Lung Carcinoma NSCLC and the Relation to Response of Treatment With Erlotinib
Sponsor:
Aarhus University Hospital
Organization:
Aarhus University Hospital
Study Overview
Official Title:
Mutations in the Epidermal Growth Factor ReceptorEGFR Gene in Non-Small Cell Lung Carcinoma NSCLC and the Relation to Response of Treatment With Erlotinib
Status:
UNKNOWN
Status Verified Date:
2008-12
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 studyn500 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 n300 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
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 studyn500 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 n300 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None