Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-28 @ 10:59 AM
Study NCT ID:
NCT05630950
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-08-24
First Post:
2022-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LDCT-SC-FI Low-dose CT Screening for Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-11-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-22', 'studyFirstSubmitDate': '2022-11-18', 'studyFirstSubmitQcDate': '2022-11-18', 'lastUpdatePostDateStruct': {'date': '2025-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of active smokers at 3 months', 'timeFrame': '3 months', 'description': 'The percentage of subjects who are actively smoking at 3 months after inclusion between the study arms'}], 'secondaryOutcomes': [{'measure': 'Number of subjects who have reduced the amount of smoked cigrattes/d at 3 months', 'timeFrame': '3 months', 'description': 'The percentage of subjects who have reduced the amount of smoked cigrattes/d at 3 months after inclusion compared to between the study arms'}, {'measure': 'Number of subjects who have reduced the amount of smoked cigrattes/d at 6 months', 'timeFrame': '6 months', 'description': 'The percentage of subjects who have reduced the amount of smoked cigrattes/d at 6 months after inclusion compared to baseline between the study arms'}, {'measure': 'The reduction in number of smoked cigarettes/d at 3 months', 'timeFrame': '3 months', 'description': 'Magnitude of reduction in number of cigarettes consumed/d at 3 month after inclusion compared to baseline between the study arms.'}, {'measure': 'The reduction in number of smoked cigarettes/d at 6 months', 'timeFrame': '6 months', 'description': 'Magnitude of reduction in number of cigarettes consumed/d at 6 month after inclusion compared to baseline between the study arms.'}, {'measure': 'The percentage of reduction in number of smoked cigarettes/d at 3 months', 'timeFrame': '3 months', 'description': 'Percentage of reduction in number of cigarettes consumed/d at 3 month after inclusion compared to baseline between the study arms.'}, {'measure': 'The percentage of reduction in number of smoked cigarettes/d at 6 months', 'timeFrame': '6 months', 'description': 'Percentage of reduction in number of cigarettes consumed/d at 6 month after inclusion compared to baseline between the study arms.'}, {'measure': 'Sensitivity of CT screening in the whole cohort', 'timeFrame': 'At 2 years', 'description': 'The amount of true positive CT scans for lung cancer compared to false negative CT scans for lung cancer.'}, {'measure': 'Costs related to CT screening including additional investigations', 'timeFrame': 'At 2 years', 'description': 'The cumulative cost of diagnostic investigations per study subject.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer Screening']}, 'referencesModule': {'references': [{'pmid': '39070744', 'type': 'DERIVED', 'citation': 'Iivanainen S, Kurtti A, Wichmann V, Andersen H, Jekunen A, Kaarteenaho R, Vasankari T, Koivunen JP. Smartphone application versus written material for smoking reduction and cessation in individuals undergoing low-dose computed tomography (LDCT) screening for lung cancer: a phase II open-label randomised controlled trial. Lancet Reg Health Eur. 2024 May 25;42:100946. doi: 10.1016/j.lanepe.2024.100946. eCollection 2024 Jul.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized phase II trial investigating different smoking cessation methods in study subjects undergoing lung cancer screening with low-dose CT (LDCT). The study also evaluates feasibility and outcomes of LDCT screening and potential biomarkers and AI-based evaluation on CT-scans. The study subjects fulfilling I/E-criteria are randomized in 1:1 fashion to yearly LDCT for two rounds with standard smoking cessation (control) or same LDCT approach combined to mobile application based smoking cessation (intervention).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to provide written informed consent\n* Age between 50-74\n* Smoked ≥ 15 cigarettes/day for ≥ 25 years or smoked ≥ 10 cigarettes/day for ≥ 30 years and are active smokers (smoking during the last two weeks)\n* Access to a smartphone (iPhone or Android)\n\nExclusion Criteria:\n\n* A moderate or bad self-reported health; e.g. unable to climb two flights of stairs\n* Body weight ≥ 140 kilogram\n* Current or past melanoma, lung, renal or breast cancer\n* A chest CT examination less than one year before inclusion\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial\n* Subject is unwilling or unable to comply with treatment and trial instructions\n* Any condition that study investigators consider an impediment to safe trial participation'}, 'identificationModule': {'nctId': 'NCT05630950', 'briefTitle': 'LDCT-SC-FI Low-dose CT Screening for Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Oulu University Hospital'}, 'officialTitle': 'Low-dose CT Screening for Lung Cancer Combined to Different Smoking Cessation Methods in Finland', 'orgStudyIdInfo': {'id': 'EETTKM 21/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Smoking cessation application', 'interventionNames': ['Device: Smoking cessation mobile application']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Written smoking cessation information', 'interventionNames': ['Behavioral: Written material for smoking cessation']}], 'interventions': [{'name': 'Smoking cessation mobile application', 'type': 'DEVICE', 'description': 'Mobile application for smoking cessation.', 'armGroupLabels': ['Smoking cessation application']}, {'name': 'Written material for smoking cessation', 'type': 'BEHAVIORAL', 'description': 'Written material for smoking cessation', 'armGroupLabels': ['Written smoking cessation information']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Oulu', 'country': 'Finland', 'facility': 'Oulu University Hospital', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'city': 'Vaasa', 'country': 'Finland', 'facility': 'Vaasa Central Hospital', 'geoPoint': {'lat': 63.096, 'lon': 21.61577}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'National legislation does not make it possible to share clinical data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oulu University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Jussi Koivunen', 'investigatorAffiliation': 'Oulu University Hospital'}}}}