Ignite Creation Date:
2025-12-24 @ 6:33 PM
Ignite Modification Date:
2026-02-03 @ 10:19 AM
Study NCT ID:
NCT02075957
Status:
UNKNOWN
Last Update Posted:
2014-03-03
First Post:
2014-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Identification by Microarrays of the Risks of Metastatic Relapse, Toxicity and Resistance to Adjuvant Chemotherapy in Completely Resected Non-small Cell Lung Cancer
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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '* Three blood samples are going to be conserved : one during the week before the operation, one four to eight weeks next to the operation and the last one, at the relapse.\n* Biopsie of non small cell lung cancer will be conserved too.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 192}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-02-27', 'studyFirstSubmitDate': '2014-02-11', 'studyFirstSubmitQcDate': '2014-02-27', 'lastUpdatePostDateStruct': {'date': '2014-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determination of news microarrays profiles of NSCLC relapse risks', 'timeFrame': '6 to 8 weeks after surgery', 'description': 'The news microarrays profiles of NSCLC relapse risks will :\n\n* assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk)\n* assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient\n* assessing the prediction of sites most likely metastatic relapse to guide survey strategy.'}, {'measure': 'Determination of news microarrays profiles of NSCLC relapse risks', 'timeFrame': 'At 1 year', 'description': 'The news microarrays profiles of NSCLC relapse risks will :\n\n* assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk)\n* assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient\n* assessing the prediction of sites most likely metastatic relapse to guide survey strategy.'}, {'measure': 'Determination of news microarrays profiles of NSCLC relapse risks', 'timeFrame': 'At 2 years', 'description': 'The news microarrays profiles of NSCLC relapse risks will :\n\n* assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk)\n* assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient\n* assessing the prediction of sites most likely metastatic relapse to guide survey strategy.'}, {'measure': 'Determination of news microarrays profiles of NSCLC relapse risks', 'timeFrame': 'At 3 years', 'description': 'The news microarrays profiles of NSCLC relapse risks will :\n\n* assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk)\n* assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient\n* assessing the prediction of sites most likely metastatic relapse to guide survey strategy.'}, {'measure': 'Determination of news microarrays profiles of NSCLC relapse risks', 'timeFrame': 'At 4 years', 'description': 'The news microarrays profiles of NSCLC relapse risks will :\n\n* assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk)\n* assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient\n* assessing the prediction of sites most likely metastatic relapse to guide survey strategy.'}, {'measure': 'Determination of news microarrays profiles of NSCLC relapse risks', 'timeFrame': 'At 5 years', 'description': 'The news microarrays profiles of NSCLC relapse risks will :\n\n* assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk)\n* assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient\n* assessing the prediction of sites most likely metastatic relapse to guide survey strategy.'}, {'measure': 'Determination of news microarrays profiles of NSCLC relapse risks', 'timeFrame': 'At 6 years', 'description': 'The news microarrays profiles of NSCLC relapse risks will :\n\n* assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk)\n* assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient\n* assessing the prediction of sites most likely metastatic relapse to guide survey strategy.'}, {'measure': 'Determination of news microarrays profiles of NSCLC relapse risks', 'timeFrame': 'At 7 years', 'description': 'The news microarrays profiles of NSCLC relapse risks will :\n\n* assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk)\n* assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient\n* assessing the prediction of sites most likely metastatic relapse to guide survey strategy.'}, {'measure': 'Determination of news microarrays profiles of NSCLC relapse risks', 'timeFrame': 'At 8 years', 'description': 'The news microarrays profiles of NSCLC relapse risks will :\n\n* assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk)\n* assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient\n* assessing the prediction of sites most likely metastatic relapse to guide survey strategy.'}, {'measure': 'Determination of news microarrays profiles of NSCLC relapse risks', 'timeFrame': 'At 9 years', 'description': 'The news microarrays profiles of NSCLC relapse risks will :\n\n* assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk)\n* assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient\n* assessing the prediction of sites most likely metastatic relapse to guide survey strategy.'}, {'measure': 'Determination of news microarrays profiles of NSCLC relapse risks', 'timeFrame': 'At 10 years', 'description': 'The news microarrays profiles of NSCLC relapse risks will :\n\n* assessing the risk of relapse in patients undergoing resection of NSCLC (by knowing this risk, patients at highest risk of relapse would be treated as a priority, while avoiding treating patients with low risk)\n* assessing the risk of chemo-resistant tumor cells characters to optimize the choice of treatment to offer to the patient\n* assessing the prediction of sites most likely metastatic relapse to guide survey strategy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Non-small cell lung cancer, adjuvant chemo-therapy, DNA chip'], 'conditions': ['Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Description of new transcriptional profiles associated with risk of relapse and identification of specific sites of relapse in non-small cell lung cancer, toxicity and resistance to adjuvant chemotherapy in completely resected non-small cell lung cancer (NSCLC).', 'detailedDescription': '* A first blood sample will be taken during the week before the operation. A second blood sample will be taken 4 to 8 weeks after the operation. And in case of relapse, a third sample will be taken. These samples are going to be stored in the collection of biological resources of Angers.\n* Concerning the biopsy of the resected NSLCL, it will be sent to the collection of biological resources of Angers for conservation directly next to the surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with non small cell lung cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Major subject\n* Subject who received resection with primary non-small cell lung cancer at the University Hospital of Angers and whose tumor samples will be stored in collection of biological resources of University Hospital of Angers\n* A written inform consent.\n\nExclusion Criteria:\n\n* Under 18 year old;\n* Pregnant or nursing women;\n* Deprived of liberty;\n* Age under curatorship or guardianship;\n* Unable to consent person;\n* About not carrying a non-small cell lung cancer.'}, 'identificationModule': {'nctId': 'NCT02075957', 'acronym': 'SITRR', 'briefTitle': 'Identification by Microarrays of the Risks of Metastatic Relapse, Toxicity and Resistance to Adjuvant Chemotherapy in Completely Resected Non-small Cell Lung Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University Hospital, Angers'}, 'officialTitle': 'Identification by Microarrays of the Risks of Metastatic Relapse, Toxicity and Resistance to Adjuvant Chemotherapy in Completely Resected Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '2012-A00827-36'}}, 'contactsLocationsModule': {'locations': [{'zip': '49933', 'city': 'Angers', 'state': 'Maine et Loire', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'José HUREAUX, Doctor', 'role': 'CONTACT', 'email': 'johureaux@chu-angers.fr', 'phone': '2 41 35 36 78', 'phoneExt': '+33'}, {'name': 'Amandine AULNETTE, CRA', 'role': 'CONTACT', 'email': 'amandine.aulnette@chu-angers.fr', 'phone': '2 41 35 80 15', 'phoneExt': '+33'}, {'name': 'José HUREAUX, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Thierry URBAN, Professor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Thierry JEANFAIVRE, Doctor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Nathalie BAIZE, Doctor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Gonzague DE CHABOT, Doctor', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Cécile RIEUX, Doctor', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'UH Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}], 'centralContacts': [{'name': 'José HUREAUX, Doctor', 'role': 'CONTACT', 'email': 'johureaux@chu-angers.fr', 'phone': '241353678', 'phoneExt': '+33'}, {'name': 'Amandine AULNETTE, CRA', 'role': 'CONTACT', 'email': 'amandine.aulnette@chu-angers.fr', 'phone': '241358015', 'phoneExt': '+33'}], 'overallOfficials': [{'name': 'José HUREAUX, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Angers'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Angers', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}