Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-01-05 @ 6:13 PM
Study NCT ID:
NCT02725892
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2016-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
National Lung Cancer Registry in Men and Women Based on Diagnosis in Algeria
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 897}, 'targetDuration': '72 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-02', 'studyFirstSubmitDate': '2016-03-11', 'studyFirstSubmitQcDate': '2016-03-29', 'lastUpdatePostDateStruct': {'date': '2022-03-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of lung cancer', 'timeFrame': '12 months of recruitment period', 'description': 'incidence of lung cancer, all types, stages and ages combined, in men and women newly diagnosed with lung cancer in Algeria over 12 months of recruitment period'}], 'secondaryOutcomes': [{'measure': 'incidence of newly diagnosed lung cancer', 'timeFrame': '12 month period', 'description': '1\\) To characterise the incidence of newly diagnosed lung cancer in Algeria in a 12 month period according to patient and disease characteristics (Wilaya, sex, age, lung cancer type, stage disease and smoking status).'}, {'measure': 'survival', 'timeFrame': 'at 12, 24, 36, 48 and 60 months of follow-up.'}, {'measure': 'quality of life -EORTC QLQ-C30', 'timeFrame': 'baseline, 3, 6 and 12 months follow-up.', 'description': 'To evaluate the quality of life of patients diagnosed with lung cancer in Algeria according to EORTC QLQ-C30 )'}, {'measure': 'Quality Of Life-EORTC QLQ- LC13', 'timeFrame': 'baseline, 3, 6 and 12 months follow-up.', 'description': 'To evaluate the quality of life of patients diagnosed with lung cancer in Algeria according to EORTC QLQ- LC13'}]}, 'conditionsModule': {'keywords': ['lung cancer epidemiology algeria registry'], 'conditions': ['Oncology & Epidemiology & Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D133FR00108&attachmentIdentifier=a710a0bc-7aec-4b11-9b83-219006bd9317&fileName=D133FR00108_Synopsis_Redacted.pdf&versionIdentifier=', 'label': 'Redacted CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'National, prospective, multicentric, non-interventional registry-based study, conducted among oncologists, pulmonologists in community and university hospitals, from the public sector in Algeria.\n\nThe study will collect information on the characteristics, and lung carcinomas patterns of patients whose lung cancer diagnosis was confirmed by a pathologist during the study period.', 'detailedDescription': "The study consists of:\n\n* All patients meeting inclusion/exclusion criteria presenting to their oncologists/pulmonologists for a routine visit during recruitment period will be sequentially asked to participate to the study.\n* The patients who do not consent will only be reported as new case of lung cancer for the incidence study.\n\nThe patients who consent to participate to the study will perform four in-hospital visits (Inclusion visit, visit at 3, 6 and 12 months). In addition to the 4 visits, a phone contact with the patients every 6 months at years 2,3, 4 and 5 will be done by the investigator or one of his/her authorised representative or the CRO or during a routine visit to the investigator, to check the patient's survival status.\n\nTHE STUDY DURATION 72 MONTHS"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'each sanitary region defined by the Ministry of health, the investigational centres will propose to all patients whom met illegibility criteria to participate to the study.\n\nWhenever possible, comprehensive lists of hospitals will be used as a data source in the site selection process. Lists will be obtained either from national authorities, local scientific societies or professional associations, depending on the local availability of this type of information. All efforts will be made to approach and select sites/physicians for the present study if they can provide a representative sample.\n\nThe formal sample size will be calculated among the representatives hospitals sites overall the country.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men or women diagnosed with lung cancer all types and stages confirmed over 12 months of recruitment period by a pathologist\n\n * Aged at least18 years at diagnosis\n * Patients who provide their informed consent form\n\nExclusion Criteria:\n\n* Patients who did not provide the informed consent form\n* Patients with a mental or psychological disorder according to their treating clinicians'}, 'identificationModule': {'nctId': 'NCT02725892', 'acronym': 'LuCaReAl', 'briefTitle': 'National Lung Cancer Registry in Men and Women Based on Diagnosis in Algeria', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'LuCaReAl: Lung Cancer Registry in Algeria.', 'orgStudyIdInfo': {'id': 'D133FR00108'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'lungcancer patients', 'description': 'Men or women diagnosed with lung cancer all types and stages confirmed over 12 months of recruitment period by a pathologist', 'interventionNames': ['Other: NIS observational stud']}], 'interventions': [{'name': 'NIS observational stud', 'type': 'OTHER', 'description': 'NIS observational study : Epidemiologic registry', 'armGroupLabels': ['lungcancer patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '16000', 'city': 'Algiers', 'country': 'Algeria', 'facility': 'Research Site', 'geoPoint': {'lat': 36.73225, 'lon': 3.08746}}, {'zip': '25000', 'city': 'Constantine', 'country': 'Algeria', 'facility': 'Research Site', 'geoPoint': {'lat': 36.365, 'lon': 6.61472}}, {'zip': '31000', 'city': 'Oran', 'country': 'Algeria', 'facility': 'Research Site', 'geoPoint': {'lat': 35.69906, 'lon': -0.63588}}], 'overallOfficials': [{'name': 'Kamel Bouzid', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CPMC'}, {'name': 'Habib Douagui, respiratory Diseases', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beni messous'}]}, 'ipdSharingStatementModule': {'url': 'https://astrazenecagroup-dt.pharmacm.com/DT/Home', 'timeFrame': 'AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.\n\nAll request will be evaluated as per the AZ disclosure commitment:\n\nhttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}