Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2026-01-24 @ 11:47 PM
Study NCT ID:
NCT02448758
Status:
UNKNOWN
Last Update Posted:
2015-05-19
First Post:
2014-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cohort of Non-small Cell Lung Cancer With Mutation of the Nord Pas de Calais (CB(NPC)²)
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': {'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 785}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-05-15', 'studyFirstSubmitDate': '2014-03-06', 'studyFirstSubmitQcDate': '2015-05-15', 'lastUpdatePostDateStruct': {'date': '2015-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between clinical factors and mutation status', 'timeFrame': 'at baseline', 'description': 'The clinical factors are age, smoking status, occupational and environmental exposure, personal and family background, TNM stage, performance status'}], 'secondaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': '3 years'}, {'measure': 'Overall survival', 'timeFrame': '3 years'}, {'measure': 'Number of patients included in a clinical trial dedicated to a certain type of non-small cell lung cancer with mutation', 'timeFrame': '3 years'}, {'measure': 'Number of cases per mutation type', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mutation'], 'conditions': ['Non-Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'The investigators propose to create a database at the regional level, the principle is to include all patients in whom a mutation was detected from a single platform (Lille). The creation of this regional cohort, smaller than the national cohort of Biomarkers France, will perform a more comprehensive collection of clinical data, and molecular monitoring data of patients included. To increase the completeness of the collection of information, it will not be based on voluntary prescribing clinician but will be largely carried out by CRA dedicated to this activity.', 'detailedDescription': 'This is a prospective and retrospective study of a population of patients with mutated non-small cell lung cancer in the Nord Pas de Calais. Retrospective cohort will involve patients with main molecular abnormalities, identifiable from molecular biology platform CRRC, except EGFR and KRAS treated from September 2011 to February 2013.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Non-small cell lung cancer with mutation of the Nord Pas de Calais', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥ 18 years old\n* Patient with non-small cell lung cancer\n* Detected in the Nord Pas de Calais\n* Monitored in the Nord Pas de Calais\n* Patient must have signed a non-opposition form to the use of medical data\n\nExclusion Criteria:\n\n\\- No identified mutation'}, 'identificationModule': {'nctId': 'NCT02448758', 'acronym': 'CB(NPC)²', 'briefTitle': 'Cohort of Non-small Cell Lung Cancer With Mutation of the Nord Pas de Calais (CB(NPC)²)', 'organization': {'class': 'OTHER', 'fullName': 'Centre Oscar Lambret'}, 'officialTitle': 'Cohort of Non-small Cell Lung Cancer With Mutation of the Nord Pas de Calais', 'orgStudyIdInfo': {'id': 'CB(NPC)²-1209'}}, 'contactsLocationsModule': {'locations': [{'zip': '59020', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Eric Dansin, MD', 'role': 'CONTACT', 'email': 'e-dansin@o-lambret.fr', 'phone': '+33 3 20 29 59 20'}, {'name': 'Eric DANSIN, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '59045', 'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Alexis Cortot, MD,PhD', 'role': 'CONTACT', 'email': 'alexis.cortot@chru-lille.fr', 'phone': '+33 3 20 44 56 12'}, {'name': 'Alexis CORTOT, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'CHRU', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'centralContacts': [{'name': 'Alexis CORTOT, MD, PhD', 'role': 'CONTACT', 'email': 'alexis.cortot@chru-lille.fr', 'phone': '+33 3 20 44 56 12'}, {'name': 'Eric Dansin, MD', 'role': 'CONTACT', 'email': 'e-dansin@o-lambret.fr', 'phone': '+33 3 20 29 59 20'}], 'overallOfficials': [{'name': 'Alexis CORTOT, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'CHRU of Lille'}, {'name': 'Eric Dansin, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Centre Oscar Lambret'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Oscar Lambret', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital, Lille', 'class': 'OTHER'}, {'name': 'Centre de Biologie Pathologie : Plateforme de Biologie Moléculaire de Lille', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}