Pharmacogenomic Study Realized on "Non-small Cell Lung Carcinoma"
NCT ID: NCT00222404
Last Updated: 2010-11-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
556 participants
OBSERVATIONAL
2005-07-31
2010-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Concomitant radiotherapy
* Cardiac disease
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ministry of Health, France
OTHER_GOV
University Hospital, Grenoble
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
DRC
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chritian Brambilla, Pr.
Role: STUDY_DIRECTOR
INSERM U578
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital of Grenoble
Grenoble, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Beer DG, Kardia SL, Huang CC, Giordano TJ, Levin AM, Misek DE, Lin L, Chen G, Gharib TG, Thomas DG, Lizyness ML, Kuick R, Hayasaka S, Taylor JM, Iannettoni MD, Orringer MB, Hanash S. Gene-expression profiles predict survival of patients with lung adenocarcinoma. Nat Med. 2002 Aug;8(8):816-24. doi: 10.1038/nm733. Epub 2002 Jul 15.
Dumontet C, Sikic BI. Mechanisms of action of and resistance to antitubulin agents: microtubule dynamics, drug transport, and cell death. J Clin Oncol. 1999 Mar;17(3):1061-70. doi: 10.1200/JCO.1999.17.3.1061.
Dumontet C, Morschhauser F, Solal-Celigny P, Bouafia F, Bourgeois E, Thieblemont C, Leleu X, Hequet O, Salles G, Coiffier B. Gemcitabine as a single agent in the treatment of relapsed or refractory low-grade non-Hodgkin's lymphoma. Br J Haematol. 2001 Jun;113(3):772-8. doi: 10.1046/j.1365-2141.2001.02795.x.
Galmarini CM, Mackey JR, Dumontet C. Nucleoside analogues and nucleobases in cancer treatment. Lancet Oncol. 2002 Jul;3(7):415-24. doi: 10.1016/s1470-2045(02)00788-x.
Howard BA, Wang MZ, Campa MJ, Corro C, Fitzgerald MC, Patz EF Jr. Identification and validation of a potential lung cancer serum biomarker detected by matrix-assisted laser desorption/ionization-time of flight spectra analysis. Proteomics. 2003 Sep;3(9):1720-4. doi: 10.1002/pmic.200300514.
Tissot C, Toffart AC, Villar S, Souquet PJ, Merle P, Moro-Sibilot D, Perol M, Zavadil J, Brambilla C, Olivier M, Couraud S. Circulating free DNA concentration is an independent prognostic biomarker in lung cancer. Eur Respir J. 2015 Dec;46(6):1773-80. doi: 10.1183/13993003.00676-2015. Epub 2015 Oct 22.
Toffart AC, Moro-Sibilot D, Couraud S, Merle P, Perol M, Girard N, Souquet PJ, Mastroianni B, Ferretti GR, Romand P, Chatellain P, Vesin A, Brambilla E, Brambilla C, Timsit JF. Evaluation of RECIST in chemotherapy-treated lung cancer: the Pharmacogenoscan Study. BMC Cancer. 2014 Dec 20;14:989. doi: 10.1186/1471-2407-14-989.
Toffart AC, Pizarro CA, Schwebel C, Sakhri L, Minet C, Duruisseaux M, Azoulay E, Moro-Sibilot D, Timsit JF. Selection criteria for intensive care unit referral of lung cancer patients: a pilot study. Eur Respir J. 2015 Feb;45(2):491-500. doi: 10.1183/09031936.00118114. Epub 2014 Oct 16.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DCIC 04 40
Identifier Type: -
Identifier Source: org_study_id