Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-02-26 @ 4:31 PM
Study NCT ID:
NCT03976804
Status:
UNKNOWN
Last Update Posted:
2021-08-09
First Post:
2019-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiological Study to Assess the Prevalence of Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-08-12', 'releaseDate': '2025-07-28'}], 'estimatedResultsFirstSubmitDate': '2025-07-28'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D009369', 'term': '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2022-12-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-08-06', 'studyFirstSubmitDate': '2019-06-03', 'studyFirstSubmitQcDate': '2019-06-05', 'lastUpdatePostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of lung cancer', 'timeFrame': '19 months', 'description': 'estimation of the prevalence of lung cancer among patients managed for atherosclerosis-related cardiovascular events associated with tobacco consumption.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer', 'Tobacco'], 'conditions': ['Lung Cancer', 'Tobacco', 'Atherosclerotic Cardiovascular Event']}, 'referencesModule': {'references': [{'pmid': '36572501', 'type': 'DERIVED', 'citation': 'Boulate D, Fidelle M, Caramella C, Issard J, Planche O, Pradere P, Garelik D, Hache O, Lamrani L, Zins M, Beaussier H, Chatellier G, Fadel E, Zitvogel L, Besse B, Mercier O. Epidemiological Study to Assess the Prevalence of Lung Cancer in patients with smoking-associated atherosclerotic cardiovascular diseases: PREVALUNG study protocol. BMJ Open. 2022 Dec 26;12(12):e067191. doi: 10.1136/bmjopen-2022-067191.'}]}, 'descriptionModule': {'briefSummary': 'Lung cancer is the main cause of mortality by cancer in France. The lung cancer stage at time of diagnosis is a major determinant of survival. To date, 75% of lung cancer are diagnosed at an advanced stage with worse survival). Lung cancer screening is based on low dose CT scan which allows to decrease lung cancer related mortality of 20% in patients aged 55-74 years-old with a history of tobacco consumption ≥ 30 PY active of who quite \\< 15 years. These criteria for eligibility for lung cancer screening lead to 1 to 2% of lung cancer diagnosis at the first CT scan. In our experience regarding 1 year of lung cancer surgical resection, only 45% of the patients presented criteria for lung cancer screening. Moreover, the duration of tobacco consumption would provide a better stratification of lung cancer risk compared to only PY. Therefore, other criteria for lung cancer screening eligibility could be proposed. Currently, 9 out of 10 lung cancer is linked with tobacco consumption which is also a major risk factor for atherosclerosis-associated cardiovascular events. Around 40% of patients with a lung cancer have a history of atherosclerosis-associated cardiovascular event, mainly coronary artery diseases and peripheral artery diseases. Main Objective: The objective is to compare the observed rate of lung cancer prevalence in our study to the rate of around 2 % observed in lung cancer screening trials in south Europe (France and Italy).\n\nThe investigators hypothesize that the population of patients with a history of atherosclerotic cardiovascular event associated with tobacco consumption present a higher prevalence of lung cancer compared with the population of patients eligible for lung cancer screening program which is defined by age and history of tobacco consumption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '45 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 45 - 75 years old\n* Patient who has signed an informed written consent\n* Daily smoking for at least 10 years\n* History of cardiovascular disease:\n\nExclusion Criteria:\n\n* History of active cancer \\< 5 years (except in situ cervical carcinoma and basal cell carcinoma of the skin)\n* Lung cancer symptoms (involuntary weight loss \\> 6.8 kg in 1 year, hemoptysis)\n* Treatment or bleeding risk syndrome contraindicating an invasive diagnostic procedure within 3 months.\n* Active pulmonary parenchymal infection\n* Severe cardiac or respiratory insufficiency (resting dyspnea)'}, 'identificationModule': {'nctId': 'NCT03976804', 'acronym': 'PREVALUNG', 'briefTitle': 'Epidemiological Study to Assess the Prevalence of Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Centre Chirurgical Marie Lannelongue'}, 'officialTitle': 'Epidemiological Study to Assess the Prevalence of Lung Cancer in Patients With Smocking-associated Atherosclerotic Cardiovascular Diseases', 'orgStudyIdInfo': {'id': '2019-A00262-55'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'atherosclerotic cardiovascular event associated with tobacco', 'interventionNames': ['Other: low dose CT scan', 'Other: blood sample collection', 'Other: faecal sample collection']}], 'interventions': [{'name': 'low dose CT scan', 'type': 'OTHER', 'description': 'Lung cancer screening will be based on the analysis of a low dose CT scan', 'armGroupLabels': ['atherosclerotic cardiovascular event associated with tobacco']}, {'name': 'blood sample collection', 'type': 'OTHER', 'description': 'establish a phenotyping of immunity, blood inflammation and digestive and tumour microbiota', 'armGroupLabels': ['atherosclerotic cardiovascular event associated with tobacco']}, {'name': 'faecal sample collection', 'type': 'OTHER', 'description': 'establish a phenotyping of immunity, blood inflammation and digestive and tumour microbiota', 'armGroupLabels': ['atherosclerotic cardiovascular event associated with tobacco']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92350', 'city': 'Le Plessis-Robinson', 'country': 'France', 'facility': 'Centre Chirurgical Marie Lannelongue', 'geoPoint': {'lat': 48.78889, 'lon': 2.27078}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Chirurgical Marie Lannelongue', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-07-28', 'type': 'RELEASE'}, {'date': '2025-08-12', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Centre Chirurgical Marie Lannelongue'}}}}