Pharmacogenomic Study Realized on "Non-small Cell Lung Carcinoma" (Pharmacogenos)

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00222404
First received: September 14, 2005
Last updated: November 4, 2010
Last verified: November 2010
  Purpose

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.


Condition
Carcinoma, Non-Small-Cell Lung

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacogenomic Study Realized Within the Framework of the Common Care to "Non-small Cell Lung Carcinoma" at Any Stages Treated by Chemotherapy.

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Enrollment: 556
Study Start Date: July 2005
Study Completion Date: August 2010
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00222404

Locations
France
University Hospital of Grenoble
Grenoble, France, 38000
Sponsors and Collaborators
University Hospital, Grenoble
Ministry of Health, France
Investigators
Study Director: Chritian Brambilla, Pr. INSERM U578
  More Information

Publications:
Responsible Party: University Hospital of Grenoble, DRC
ClinicalTrials.gov Identifier: NCT00222404     History of Changes
Other Study ID Numbers: DCIC 04 40
Study First Received: September 14, 2005
Last Updated: November 4, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by University Hospital, Grenoble:
Carcinoma, Non-Small-Cell Lung
Pharmacogenomic

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 21, 2014