Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2025-12-26 @ 3:57 AM
Study NCT ID:
NCT01052818
Status:
UNKNOWN
Last Update Posted:
2010-01-20
First Post:
2010-01-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Therapeutic and Prognostic Impact of Circulating Tumor Cells in Peripheral Blood in Patients With Non Small-cell Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009360', 'term': 'Neoplastic Cells, Circulating'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Peripheral blood samples are collected were the cell pellet are collected from centrifugation, lysed by TRIzol method to get RNA. The RNA is retrotranscribed to cDNA in order to quantify cytokeratin (CK) 19, 18 and carcinoembrionic antigen which are markers of epithelial cells presumambly coming form the tumor.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'lastUpdateSubmitDate': '2010-01-18', 'studyFirstSubmitDate': '2010-01-18', 'studyFirstSubmitQcDate': '2010-01-18', 'lastUpdatePostDateStruct': {'date': '2010-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate, progression-free survival and over-all survival', 'timeFrame': '4 years'}], 'secondaryOutcomes': [{'measure': 'Quantification of CTCs', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Non small-cell lung cancer', 'Circulating tumor cells', 'Carcinoembryonic antigen', 'Cytokeratin'], 'conditions': ['Circulating Tumor Cells']}, 'referencesModule': {'references': [{'pmid': '24934364', 'type': 'DERIVED', 'citation': 'Arrieta O, Pineda B, Muniz-Hernandez S, Flores D, Ordonez G, Borbolla-Escoboza JR, Orta D. Molecular detection and prognostic value of epithelial markers mRNA expression in peripheral blood of advanced non-small cell lung cancer patients. Cancer Biomark. 2014;14(4):215-23. doi: 10.3233/CBM-140394.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the association between the number of circulating tumor cells and response to treatment in non small-cell lung cancer patients', 'detailedDescription': 'In spite of technological advantages in diagnosis and treatment, lung cancer remains one of the most deadly malignant neoplasias. Moreover, there are no markers for monitoring response to treatment. The objective of the study is to associate the number of circulating tumor cells (CTC) before and after treatment and correlate it with tumor response rate, progression-free survival and overall survival.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Advanced non small-cell lung cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histopathologic diagnosis of non small-cell lung cancer\n* Clinical stage IV\n* ECOG functional status 0 or 1\n* No renal function alteration (GFR \\>50%)\n* No hepatic function alteration (ALT and AST less than 2 times its normal value)\n* Leucocytes more than 2,000/mcl\n* Hemoglobin more than 10mg/dL\n* Platelets more than 100,000/mcl\n\nExclusion Criteria:\n\nNon-advanced disease'}, 'identificationModule': {'nctId': 'NCT01052818', 'briefTitle': 'Therapeutic and Prognostic Impact of Circulating Tumor Cells in Peripheral Blood in Patients With Non Small-cell Lung Cancer', 'organization': {'class': 'OTHER_GOV', 'fullName': 'National Institute of Cancerología'}, 'orgStudyIdInfo': {'id': 'INCAN/OfCA204/SO151/CB451/09'}, 'secondaryIdInfos': [{'id': '87453', 'type': 'OTHER', 'domain': 'National Counsil of Science and Technology'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Stage IV NSCLC', 'description': 'Stage IV non small-cell lung cancer patients will be recruited for this protocol'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14080', 'city': 'Mexico City', 'state': 'Mexico City', 'status': 'RECRUITING', 'country': 'Mexico', 'contacts': [{'name': 'Oscar Arrieta, MD', 'role': 'CONTACT', 'email': 'ogar@servidor.unam.mx', 'phone': '(0155)56280400', 'phoneExt': '832'}, {'name': 'Oscar Arrieta, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Institute of Cancerologia', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'centralContacts': [{'name': 'Oscar Arrieta, MD', 'role': 'CONTACT', 'email': 'ogar@servidor.unam.mx', 'phone': '(0155)56280400', 'phoneExt': '832'}], 'overallOfficials': [{'name': 'Oscar Arrieta, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Counsil of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute of Cancerología', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'Oscar Arrieta Rodriguez', 'oldOrganization': 'CONACyT'}}}}