Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00222404
Status:
COMPLETED
Last Update Posted:
2010-11-05
First Post:
2005-09-14
Brief Title:
Pharmacogenomic Study Realized on Non-small Cell Lung Carcinoma
Sponsor:
University Hospital Grenoble
Organization:
University Hospital Grenoble
Study Overview
Official Title:
Pharmacogenomic Study Realized Within the Framework of the Common Care to Non-small Cell Lung Carcinoma at Any Stages Treated by Chemotherapy
Status:
COMPLETED
Status Verified Date:
2010-11
Last Known Status:
None
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:
Pharmacogenos
Brief Summary:
The purpose of this study is to correlate molecular genetic profile with response to chemotherapy in case of primary chemotherapy treatment for non-small cells lung carcinoma
Detailed Description:
Lung carcinoma will be the fifth death cause in the world in 2020 In Europe it causes more deaths than carcinoma of breast colon and prostate combined so it is a public healthcare priority Applying high throughput molecular analysis technologies to pharmacogenomics could improve lung carcinoma care strategies The study hypothesis is that the determination of the genomic and proteomic profiles of non-small cell lung carcinoma patients will allow treatment targeting improving treatment efficacy and tolerance
In order to carry out this study the five thoracic oncology centers of the Rhône-Alpes region will collaborate with several INSERM French national research institute units and new biotechnology companies
The primary objective of this study is to correlate molecular genetic profile with response to chemotherapy in cases of primary chemotherapy treatment for non-small cell lung carcinomas
Biological samples will be collected before and during patient care to correlate clinical evolution response and tolerance with
circulating cell polymorphism profile
proteomic profile
genetic and epigenetic modifications of genes involved in DNA repair drugs metabolism apoptosis cell regulation mechanisms and cell mobility and adhesion mechanisms
The main judgment criteria will be response to chemotherapy correlated with patients biological profile
Second judgment criteria will be overall survival and hematology toxicity which will be evaluated each new cycle of chemotherapy
The second purpose of this study is to validate less invasive methods of sampling using blood expectoration urine fixed biopsies and lungs tapping as a substitute to the current reference frozen tumor which is out of reach in clinical examination
This will contribute to setting of a multicentric resources bank to define targets for new drugs and to develop oligoarrays allowing adapted chemotherapies
Two previous studies 1800 and 500 patients respectively have already been carried out data and samples are available
For this study 600 patients will be included over 3 years
In order to carry out this study the five thoracic oncology centers of the Rhône-Alpes region will collaborate with several INSERM French national research institute units and new biotechnology companies
The primary objective of this study is to correlate molecular genetic profile with response to chemotherapy in cases of primary chemotherapy treatment for non-small cell lung carcinomas
Biological samples will be collected before and during patient care to correlate clinical evolution response and tolerance with
circulating cell polymorphism profile
proteomic profile
genetic and epigenetic modifications of genes involved in DNA repair drugs metabolism apoptosis cell regulation mechanisms and cell mobility and adhesion mechanisms
The main judgment criteria will be response to chemotherapy correlated with patients biological profile
Second judgment criteria will be overall survival and hematology toxicity which will be evaluated each new cycle of chemotherapy
The second purpose of this study is to validate less invasive methods of sampling using blood expectoration urine fixed biopsies and lungs tapping as a substitute to the current reference frozen tumor which is out of reach in clinical examination
This will contribute to setting of a multicentric resources bank to define targets for new drugs and to develop oligoarrays allowing adapted chemotherapies
Two previous studies 1800 and 500 patients respectively have already been carried out data and samples are available
For this study 600 patients will be included over 3 years
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