Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-02-22 @ 4:13 PM
Study NCT ID:
NCT01658332
Status:
TERMINATED
Last Update Posted:
2015-07-30
First Post:
2012-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Circulating Tumor Cells in Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D009360', 'term': 'Neoplastic Cells, Circulating'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial 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'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 59}}, 'statusModule': {'whyStopped': 'unavailability of the investigator due to an overloaded planning', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-29', 'studyFirstSubmitDate': '2012-06-16', 'studyFirstSubmitQcDate': '2012-08-06', 'lastUpdatePostDateStruct': {'date': '2015-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification of circulating tumor cells in locally advanced, and metastatic non-small cell lung cancer.', 'timeFrame': '18 months', 'description': 'Circulating tumor cells will be search with the Veridex method, and a value per 7.5 f blood will be recorded.'}], 'secondaryOutcomes': [{'measure': 'Identification of a cellular profile according to clinical factors (sex,histology, …).', 'timeFrame': '18 months', 'description': 'epidemiological,and clinical characteristics of patients with advanced lung cancer'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['lung cancer', 'circulating tumor cells', 'prospective', 'monocentrique trial'], 'conditions': ['Stage IIIB Non Small Cell Lung Cancer', 'Stage IV Non-small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'TITLE : Circulating tumor cells identification in advanced stage non-small cell lung cancer (CIRCUBRONCH)\n\nBACKGROUND : Circulating tumor cells identification is a new field of research in oncology, and some studies have been conducted with success on breast and prostate cancer. Nearly 80% of lung cancers are diagnosed in an advanced stage (IIIB, and IV). Circulating tumor cells identification and monitoring these cells after treatment could help the clinicians to detect relapse or be a prognostic factor.\n\nPRIMARY OBJECTIVE : Circulating tumor cells identification, and monitoring in advanced stage lung cancers (IIIB and IV).\n\nSECONDARY OBJECTIVES : Predictive value of the monitoring of circulating tumor cells on the therapeutic response. Prognostic value of identification of circulating tumor cells at the time of diagnosis.\n\nSTUDY DESIGN : This study is a prospective, monocentrique trial analyzing the identification of circulating tumor cells in stage IIIB, and IV non-small cell lung cancers.\n\nDuration of the inclusions: 54 months.\n\nDuration of the study: 66 months.\n\nPROCEDURES : Detection of circulating tumor cells with CellSearch system (Veridex), and a cut-off of 5 cells/7,5 ml of blood.\n\nSAMPLE SIZE : 200 patients\n\nSTATISTICAL ANALYSIS : Detection of circulating tumor cells is predicted in 20% of stage IIIB, and IV non-small cell lung cancers included in this study. The cut-off is 5 circulating tumor cells per 7,5 ml of blood.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Advanced stage NSCLC (stages IIIB, and IV) with measurable or evaluable disease at diagnosis.\n* Age ≥ 18 years.\n* Measurable or evaluable disease according to RECIST criteria.\n* Ability to sign informed consent.\n\nExclusion Criteria:\n\n* Prior cancers within 5 years, except for non-melanoma skin cancers, and in situ cervical cancers.\n* Prior chemotherapy, radiation or surgery for lung cancer.\n* Inability to comply with study and/or follow-up procedures.'}, 'identificationModule': {'nctId': 'NCT01658332', 'acronym': 'CIRCUBRONCH', 'briefTitle': 'Circulating Tumor Cells in Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Circulating Tumor Cells Identification in Advanced Stage Non-small Cell Lung Cancer', 'orgStudyIdInfo': {'id': '2012-A00135-38'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'specific procedure', 'description': 'Circulating tumor cells will be search with the Veridex method at inclusion and after the third chimiotherapy', 'interventionNames': ['Other: blood samples']}], 'interventions': [{'name': 'blood samples', 'type': 'OTHER', 'description': '3 tubes (15 ml)', 'armGroupLabels': ['specific procedure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54511', 'city': 'Nancy', 'country': 'France', 'facility': 'Christelle Clement-Duchene', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}], 'overallOfficials': [{'name': 'Christelle CLEMENT-DUCHENE, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU NANCY'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}