Clinical trial NCT00222404: Pharmacogenomic Study Realized on "Non-small Cell Lung Carcinoma"
Official title: Pharmacogenomic Study Realized Within the Framework of the Common Care to "Non-small Cell Lung Carcinoma" at Any Stages Treated by Chemotherapy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Carcinoma, Non-Small-Cell Lung
Pharmacogenomic
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2005-09-22
Enrollment: 556
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient older than 18 suffering from Non-Small-Cell Lung Carcinoma

* Patient treated by chemotherapy with platinum salt
* Every stage TNM classification
* No previous chemotherapy
* One measurable lesion out of nervous central system at least

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 patient's 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.

Eligibility criteria: Inclusion Criteria:

* Patient older than 18 suffering from Non-Small-Cell Lung Carcinoma
* Patient treated by chemotherapy with platinum salt
* Every stage TNM classification
* No previous chemotherapy
* One measurable lesion out of nervous central system at least
* Performance status from 0 to 2 on ECOG scale
* Life expectancy \> 12 weeks

Exclusion Criteria:

* Previous or Concomitant carcinoma over 5 last years
* Concomitant radiotherapy
* Cardiac disease

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital of Grenoble
Study officials:
affiliation: INSERM U578
name: Chritian Brambilla, Pr.
role: STUDY_DIRECTOR
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