Ignite Creation Date:
2025-12-24 @ 11:46 PM
Ignite Modification Date:
2025-12-29 @ 10:10 PM
Study NCT ID:
NCT07015151
Status:
RECRUITING
Last Update Posted:
2025-09-09
First Post:
2025-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mobile Lung Cancer Screening
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013147', 'term': 'Spirometry'}], 'ancestors': [{'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'The following types of biospecimens will be retained for ancillary analyses:\n\n* Exhaled breath condensate\n* Blood samples\n\nThese specimens will be collected at baseline and at the end of the intervention phase, then stored for subsequent analysis in the context of the Bio-ILYAD study (biobank).'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 4312}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2025-06-03', 'studyFirstSubmitQcDate': '2025-06-03', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Creation of CT image database', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': 'Establishment of a thoracic imaging repository for AI model training and teaching purposes.'}], 'primaryOutcomes': [{'measure': 'Proportion of socially deprived participants included in the mobile screening group', 'timeFrame': 'Baseline (Day 0)', 'description': 'The percentage of participants with an EPICES score ≥ 4 (indicating social vulnerability) in the mobile screening arm, compared to the non-mobile arm.'}], 'secondaryOutcomes': [{'measure': 'Participation by socio-demographic profile', 'timeFrame': 'Inclusion', 'description': "Comparison of participants' characteristics between the two modalities (smoking status, age, sex, socio-professional category, income level, education, perceived ethnic identity, geographic isolation, presence of a general practitioner)."}, {'measure': 'Mobile feasibility', 'timeFrame': 'Throughout inclusion period', 'description': 'Feasibility of the mobile screening pathway, assessed by the attendance rate (proportion of invited participants who attend the mobile unit) and the completion rate (proportion of those attendees who complete the full screening process). Both will be reported separately as percentages.\n\nUnit of Measure: Percentage of participants (%)'}, {'measure': 'Feasibility of task-shifting to nurses', 'timeFrame': 'Throughout inclusion period', 'description': 'Rate of recourse to a physician and participant satisfaction in each modality.'}, {'measure': 'Adherence to intermediate CT scans', 'timeFrame': 'Month 1, Month 3, Month 6 if clinically indicated', 'description': 'Proportion of participants who undergo intermediate follow-up CTs when required.'}, {'measure': 'Adherence to 12-month CT scan', 'timeFrame': 'At Month 12', 'description': 'Proportion of participants who complete the scheduled CT scan at one year.'}, {'measure': 'Adherence to tobacco cessation consultations', 'timeFrame': 'Over 12 months', 'description': 'Proportion of active smokers who attend the initial and, if applicable, follow-up cessation visits.'}, {'measure': 'Smoking cessation success', 'timeFrame': 'At 12 months', 'description': 'Self-reported complete tobacco cessation at 12 months.'}, {'measure': 'Rate of positive screening', 'timeFrame': 'Up to 3 months post-initial CT', 'description': 'Proportion of participants with positive CT findings and subsequent medical workup.'}, {'measure': 'Lung cancer incidence', 'timeFrame': 'Over 12 months', 'description': 'Number and percentage of participants diagnosed with lung cancer during the 12-month follow-up.'}, {'measure': 'COPD detection relevance', 'timeFrame': 'Baseline and 12 months', 'description': 'Rate of new COPD diagnoses and associated therapeutic modifications; respiratory morbidity and mortality over 12 months.'}, {'measure': 'Cardiovascular risk detection relevance', 'timeFrame': 'Baseline and 12 months', 'description': 'Rate of high-risk participants identified, therapeutic implications, cardiovascular events over follow-up.'}, {'measure': 'Creation of biobank (Bio-ILYAD)', 'timeFrame': 'At inclusion', 'description': 'Proportion of participants consenting to blood and exhaled air sample collection for future biomarker research.'}, {'measure': 'Lung cancer staging', 'timeFrame': 'Within 12 months', 'description': 'Distribution of lung cancer cases by stage at diagnosis (I-IV), as recorded in clinical reports. Number of participants per stage'}, {'measure': 'Histological type of diagnosed lung cancers', 'timeFrame': 'Within 12 month', 'description': 'Categorization of diagnosed lung cancers by histological type (e.g., adenocarcinoma, squamous cell carcinoma, small cell). Number of participants per histological category'}, {'measure': 'Initial treatment of diagnosed lung cancers', 'timeFrame': 'Within 3 months of diagnosis', 'description': 'Description and frequency of initial treatment modalities (e.g., surgery, radiotherapy, systemic therapy). Number of participants per treatment type'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prevention', 'Lung cancer', 'screening', 'tobacco'], 'conditions': ['Lung Cancer Prevention']}, 'descriptionModule': {'briefSummary': 'Lung cancer screening using low-dose CT (LDCT) has been shown to reduce mortality in high-risk populations. In 2022, the French National Cancer Institute (INCa) issued guidelines recommending screening for individuals aged 50-74 with a history of heavy smoking, including current smokers or those who quit less than 15 years ago. A national pilot program (IMPULSION) will be launched in 2025.\n\nLung cancer incidence is strongly correlated with socioeconomic status, yet underserved populations remain difficult to engage in screening programs. Mobile health units using a "reach-out" strategy have demonstrated effectiveness in other countries (UK, Brazil, USA). In France, this approach has been used for breast cancer screening via mobile mammography units.\n\nThe MobILYAD project aims to compare two screening modalities- a mobile demedicalized unit (CT-equipped van with trained nurses) and a conventional hospital-based unit- to assess the effectiveness of mobile screening in reaching socially disadvantaged populations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults aged 50 to 74 years with a significant history of smoking, currently smoking or former smokers who quit within the past 15 years. The study targets individuals eligible for lung cancer screening per national guidelines, with a focus on those from socially deprived backgrounds. Recruitment will be carried out through a mobile screening unit or a fixed hospital site, depending on geographic location.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria \\* :\n\n* Persons aged over 50 and under 75 (74 years of age or older).\n* Active smokers or former smokers who quit less than 15 years ago.\n* Persons whose consumption is estimated at 20 packs/year or more, down to ≥15 cigarettes/day for a duration of consumption of ≥25 years and up to ≥10 cigarettes/day for ≥30 years, which takes into account the predominance of duration of consumption over quantity consumed in the risk of lung cancer. A pack-year corresponds to the consumption of one pack of 20 manufactured cigarettes per day for one year. A multiplier coefficient will be taken into account depending on the mode of consumption: Rolled cigarettes: 2; Cigarillos: 3; Cigars: 4; Pipes: 2.5; Hookahs: 25.\n* Persons affiliated with social security. - Person having signed their consent to participate in the study after having received full information about it, including the risks associated with participation.\n\n * Exclusion Criteria \\* :\n* Individuals with severe comorbidities contraindicating lung cancer investigations and/or treatment (including surgery or stereotactic radiotherapy);\n* Individuals with impaired general condition (PS 2 and above);\n* Individuals with dyspnea at rest (mMRC4);\n* Individuals with a history of cancer undergoing active surveillance by chest computed tomography (CT or PET scan); personal history of lung cancer (lifetime);\n* Individuals with symptoms suggestive of lung cancer (hemoptysis, unexplained weight loss, recent onset or change in respiratory symptoms, etc.);\n* Individuals refusing to participate in the study\n* Individuals withdrawing their consent.'}, 'identificationModule': {'nctId': 'NCT07015151', 'acronym': 'MobILYAD', 'briefTitle': 'Mobile Lung Cancer Screening', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Lyon Initiative for the Mobile Demedicalized Initiation of Lung Cancer Screening', 'orgStudyIdInfo': {'id': '69HCL22_0467'}, 'secondaryIdInfos': [{'id': '2025-A00673-46', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mobile Screening Group', 'description': 'Participants receiving lung cancer screening via a mobile unit (truck) operated by trained nurses. This includes spirometry, blood pressure measurement, blood cholesterol testing, low-dose CT scan, and optional biospecimen collection.', 'interventionNames': ['Diagnostic Test: Low-dose Chest CT Screening', 'Diagnostic Test: Spirometry', 'Diagnostic Test: Cardiovascular Risk Assessment', 'Behavioral: Smoking Cessation Support', 'Other: Optional Biospecimen Collection (Bio-ILYAD)']}, {'label': 'Non-Mobile Screening Group', 'description': 'Participants receiving the same screening procedures at a fixed hospital-based site (Lyon Sud), with possible involvement of medical or non-medical staff depending on availability.', 'interventionNames': ['Diagnostic Test: Low-dose Chest CT Screening', 'Diagnostic Test: Spirometry', 'Diagnostic Test: Cardiovascular Risk Assessment', 'Behavioral: Smoking Cessation Support', 'Other: Optional Biospecimen Collection (Bio-ILYAD)']}], 'interventions': [{'name': 'Low-dose Chest CT Screening', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants undergo a low-dose chest CT scan to screen for early lung cancer and assess associated conditions (emphysema, coronary calcifications, osteoporosis).', 'armGroupLabels': ['Mobile Screening Group', 'Non-Mobile Screening Group']}, {'name': 'Spirometry', 'type': 'DIAGNOSTIC_TEST', 'description': 'Assessment of lung function through spirometry, with optional plethysmography and diffusion testing to detect COPD and PRISM patterns.', 'armGroupLabels': ['Mobile Screening Group', 'Non-Mobile Screening Group']}, {'name': 'Cardiovascular Risk Assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'Cardiovascular risk is evaluated using SCORE2/SCORE2-OP tools, based on blood pressure and cholesterol levels.', 'armGroupLabels': ['Mobile Screening Group', 'Non-Mobile Screening Group']}, {'name': 'Smoking Cessation Support', 'type': 'BEHAVIORAL', 'description': 'Active smokers receive a structured smoking cessation intervention, including a baseline consultation and up to two follow-up sessions (which may be remote).', 'armGroupLabels': ['Mobile Screening Group', 'Non-Mobile Screening Group']}, {'name': 'Optional Biospecimen Collection (Bio-ILYAD)', 'type': 'OTHER', 'description': 'Optional collection of blood and exhaled breath condensate for future analysis of biomarkers in lung cancer detection.', 'armGroupLabels': ['Mobile Screening Group', 'Non-Mobile Screening Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69310', 'city': 'Pierre-Bénite', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sébastien COURAUD, Pr', 'role': 'CONTACT', 'email': 'sebastien.couraud@chu-lyon.fr', 'phone': '00334 78 86 44 01'}], 'facility': '" Centre de dépistage mobile " - Hôpital Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '69310', 'city': 'Pierre-Bénite', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'COURAUD Sébastien, Pr', 'role': 'CONTACT', 'email': 'sebastien.couraud@chu-lyon.fr', 'phone': '0033 4 78 86 44 01'}], 'facility': 'Service de Pneumologie " Centre de dépistage non mobile " - Hôpital Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}], 'centralContacts': [{'name': 'Sébastien COURAUD, Pr', 'role': 'CONTACT', 'email': 'sebastien.couraud@chu-lyon.fr', 'phone': '04 78 86 44 01', 'phoneExt': '+33'}, {'name': 'Julie DE-BELMONT', 'role': 'CONTACT', 'email': 'Julie.de-bermont@chu-lyon.fr', 'phone': '0478866698', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'A decision on sharing individual participant data has not yet been made. Data sharing will depend on sponsor policy, ethical approval, and compliance with applicable regulations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}