Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2025-12-25 @ 6:59 PM
Study NCT ID:
NCT00222404
Status:
COMPLETED
Last Update Posted:
2010-11-05
First Post:
2005-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacogenomic Study Realized on "Non-small Cell Lung Carcinoma"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 556}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-04', 'studyFirstSubmitDate': '2005-09-14', 'studyFirstSubmitQcDate': '2005-09-16', 'lastUpdatePostDateStruct': {'date': '2010-11-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-22', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Carcinoma, Non-Small-Cell Lung', 'Pharmacogenomic'], 'conditions': ['Carcinoma, Non-Small-Cell Lung']}, 'referencesModule': {'references': [{'pmid': '12118244', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10071301', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '11380469', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '12142171', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12973732', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26493785', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '25527907', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '25323247', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nIn 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.\n\nThe 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.\n\nBiological samples will be collected before and during patient care to correlate clinical evolution (response and tolerance) with:\n\n* circulating cell polymorphism profile\n* proteomic profile\n* genetic and epigenetic modifications of genes involved in DNA repair, drugs metabolism, apoptosis cell regulation mechanisms, and cell mobility and adhesion mechanisms.\n\nThe main judgment criteria will be response to chemotherapy correlated with patient's biological profile.\n\nSecond judgment criteria will be overall survival and hematology toxicity which will be evaluated each new cycle of chemotherapy.\n\nThe 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.\n\nThis will contribute to setting of a multicentric resources bank, to define targets for new drugs and to develop oligoarrays allowing adapted chemotherapies.\n\nTwo previous studies (1800 and 500 patients respectively) have already been carried out, data and samples are available.\n\nFor this study, 600 patients will be included over 3 years."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient older than 18 suffering from Non-Small-Cell Lung Carcinoma\n\n* Patient treated by chemotherapy with platinum salt\n* Every stage TNM classification\n* No previous chemotherapy\n* One measurable lesion out of nervous central system at least', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient older than 18 suffering from Non-Small-Cell Lung Carcinoma\n* Patient treated by chemotherapy with platinum salt\n* Every stage TNM classification\n* No previous chemotherapy\n* One measurable lesion out of nervous central system at least\n* Performance status from 0 to 2 on ECOG scale\n* Life expectancy \\> 12 weeks\n\nExclusion Criteria:\n\n* Previous or Concomitant carcinoma over 5 last years\n* Concomitant radiotherapy\n* Cardiac disease'}, 'identificationModule': {'nctId': 'NCT00222404', 'acronym': 'Pharmacogenos', 'briefTitle': 'Pharmacogenomic Study Realized on "Non-small Cell Lung Carcinoma"', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Pharmacogenomic Study Realized Within the Framework of the Common Care to "Non-small Cell Lung Carcinoma" at Any Stages Treated by Chemotherapy.', 'orgStudyIdInfo': {'id': 'DCIC 04 40'}}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Grenoble', 'country': 'France', 'facility': 'University Hospital of Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}], 'overallOfficials': [{'name': 'Chritian Brambilla, Pr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'INSERM U578'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'University Hospital of Grenoble', 'oldOrganization': 'DRC'}}}}