Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-02-24 @ 2:46 AM
Study NCT ID:
NCT03328559
Status:
COMPLETED
Last Update Posted:
2021-08-23
First Post:
2017-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kinetics of Circulating Tumoral Cells in Bronchial Primitive Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}], 'ancestors': [{'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2021-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-20', 'studyFirstSubmitDate': '2017-10-23', 'studyFirstSubmitQcDate': '2017-10-30', 'lastUpdatePostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'numeration of CTC (circulant tumoral cell)', 'timeFrame': 'Day 1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bronchial Cancer']}, 'descriptionModule': {'briefSummary': "The pronostic value of Circulating Tumoral Cells(CTC) 's dosage by the method ISET® (tumoral cell isolation by size) in patients with bronchial cancer was previously demonstrated.\n\nHowever, no kinetic study was ever realized to study the value of the CTC as predictive indicator of answer to the therapy. This project plans to study patients in an early stage and patients at advance stage locally moved forward or metastatic of the disease by evaluation of the presence and the number of CTC before every cure. This collaborative and original study should allow to refine the diagnoses of answer and to plan the possible relapses what would allow a premature institution of the treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with non-small cell lung cancer\n* accepting participation\n\nExclusion Criteria:\n\n* refusing participation'}, 'identificationModule': {'nctId': 'NCT03328559', 'briefTitle': 'Kinetics of Circulating Tumoral Cells in Bronchial Primitive Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Fondation Hôpital Saint-Joseph'}, 'officialTitle': 'Kinetics of Circulating Tumoral Cells in Bronchial Primitive Cancer', 'orgStudyIdInfo': {'id': 'CTC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'early stage bronchial cancer', 'description': 'Early stage which can benefit from a surgical resection. A taking will be made in preoperative then in every consultation of follow-up after the intervention', 'interventionNames': ['Diagnostic Test: ISET® - Isolation by Size of Tumor cells']}, {'type': 'OTHER', 'label': 'advanced stage bronchial cancer', 'description': 'Patients locally moved forward or at a metastatic stage handled by chemotherapy', 'interventionNames': ['Diagnostic Test: ISET® - Isolation by Size of Tumor cells']}], 'interventions': [{'name': 'ISET® - Isolation by Size of Tumor cells', 'type': 'DIAGNOSTIC_TEST', 'description': 'early stage bronchial cancer patient will have a blood collection', 'armGroupLabels': ['early stage bronchial cancer']}, {'name': 'ISET® - Isolation by Size of Tumor cells', 'type': 'DIAGNOSTIC_TEST', 'description': 'advanced stage bronchial cancer patient will have a blood collection', 'armGroupLabels': ['advanced stage bronchial cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'Groupe Hospitalier Paris Saint Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Jean P Tredaniel, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondation Hôpital Saint-Joseph'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondation Hôpital Saint-Joseph', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}