Lung Cancer ScreeningNCT05630950
LDCT-SC-FI Low-dose CT Screening for Lung Cancer
A study testing Smoking cessation mobile application and Written material for smoking cessation in people with Lung Cancer Screening, run by Oulu University Hospital at 2 sites in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer Screening
- What is being tested?
- Smoking cessation mobile application and Written material for smoking cessation
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesFinland
- Study dates
- 18 Nov 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to provide written informed consent
- Age between 50-74
- 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)
- Access to a smartphone (iPhone or Android)
Who cannot join
- A moderate or bad self-reported health; e.g. unable to climb two flights of stairs
- Body weight ≥ 140 kilogram
- Current or past melanoma, lung, renal or breast cancer
- A chest CT examination less than one year before inclusion
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
- Subject is unwilling or unable to comply with treatment and trial instructions
- Any condition that study investigators consider an impediment to safe trial participation
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Low-dose CT Screening for Lung Cancer Combined to Different Smoking Cessation Methods in Finland
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).
- Conditions
- Lung Cancer Screening
- Being tested
- Smoking cessation mobile application, Written material for smoking cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking cessation mobile applicationDevice
Mobile application for smoking cessation.
Written material for smoking cessationBehavioural
Written material for smoking cessation
| Study group | Role | What they receive |
|---|---|---|
| Smoking cessation application | Experimental | Not described Receives: Device: Smoking cessation mobile application |
| Written smoking cessation information | Active comparator | Not described Receives: Behavioral: Written material for smoking cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of active smokers at 3 months
The percentage of subjects who are actively smoking at 3 months after inclusion between the study arms
Measured: 3 months
Secondary outcomes (8)
Number of subjects who have reduced the amount of smoked cigrattes/d at 3 months
The percentage of subjects who have reduced the amount of smoked cigrattes/d at 3 months after inclusion compared to between the study arms
Measured: 3 months
Number of subjects who have reduced the amount of smoked cigrattes/d at 6 months
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
Measured: 6 months
The reduction in number of smoked cigarettes/d at 3 months
Magnitude of reduction in number of cigarettes consumed/d at 3 month after inclusion compared to baseline between the study arms.
Measured: 3 months
The reduction in number of smoked cigarettes/d at 6 months
Magnitude of reduction in number of cigarettes consumed/d at 6 month after inclusion compared to baseline between the study arms.
Measured: 6 months
The percentage of reduction in number of smoked cigarettes/d at 3 months
Percentage of reduction in number of cigarettes consumed/d at 3 month after inclusion compared to baseline between the study arms.
Measured: 3 months
The percentage of reduction in number of smoked cigarettes/d at 6 months
Percentage of reduction in number of cigarettes consumed/d at 6 month after inclusion compared to baseline between the study arms.
Measured: 6 months
Sensitivity of CT screening in the whole cohort
The amount of true positive CT scans for lung cancer compared to false negative CT scans for lung cancer.
Measured: At 2 years
Costs related to CT screening including additional investigations
The cumulative cost of diagnostic investigations per study subject.
Measured: At 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start18 Nov 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oulu University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jussi Koivunen, Oulu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630950
- Sponsor's protocol ID
- EETTKM 21/2022
- Status last verified
- Aug 2025
- First submitted
- 18 Nov 2022
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: National legislation does not make it possible to share clinical data.
Publications
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.
PubMed 39070744
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose CT Screening for Lung Cancer Combined to Different Smoking Cessation Methods in Finland
- ClinicalTrials.gov ID
- NCT05630950
- Acronym / sponsor ID
- EETTKM 21/2022
- Conditions
- Lung Cancer Screening
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Oulu University HospitalUniversity, hospital or other
- Study start
- 18 Nov 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smoking cessation application | Experimental | Device: Smoking cessation mobile application |
| Written smoking cessation information | Active comparator | Behavioral: Written material for smoking cessation |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Able to provide written informed consent
- Age between 50-74
- 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)
- Access to a smartphone (iPhone or Android)
Key exclusion criteria (7 listed)
- A moderate or bad self-reported health; e.g. unable to climb two flights of stairs
- Body weight ≥ 140 kilogram
- Current or past melanoma, lung, renal or breast cancer
- A chest CT examination less than one year before inclusion
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking cessation mobile applicationMobile application for smoking cessation. | Device | Smoking cessation application |
| Written material for smoking cessationWritten material for smoking cessation | Behavioural | Written smoking cessation information |
Primary outcome
Number of active smokers at 3 months
Time frame: 3 months
The percentage of subjects who are actively smoking at 3 months after inclusion between the study arms
8 secondary outcomes
Number of subjects who have reduced the amount of smoked cigrattes/d at 3 months
Time frame: 3 months
Number of subjects who have reduced the amount of smoked cigrattes/d at 6 months
Time frame: 6 months
The reduction in number of smoked cigarettes/d at 3 months
Time frame: 3 months
The reduction in number of smoked cigarettes/d at 6 months
Time frame: 6 months
The percentage of reduction in number of smoked cigarettes/d at 3 months
Time frame: 3 months
The percentage of reduction in number of smoked cigarettes/d at 6 months
Time frame: 6 months
Sensitivity of CT screening in the whole cohort
Time frame: At 2 years
Costs related to CT screening including additional investigations
Time frame: At 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Derived from this study: PubMed 39070744Iivanainen 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.
- Individual participant dataSharing planned: No. National legislation does not make it possible to share clinical data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smoking cessation mobile application and Written material for smoking cessation in people with Lung Cancer Screening, run by Oulu University Hospital at 2 sites in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of active smokers at 3 months (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05630950, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.