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Active, not recruitingNCT05630950Updated Aug 24, 2025

LDCT-SC-FI Low-dose CT Screening for Lung Cancer

An interventional study of Smoking cessation mobile application and Written material for smoking cessation in Lung Cancer Screening, sponsored by Oulu University Hospital. Active, not recruiting at 2 sites in Finland. Open to participants aged 50 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-24.

Sponsored by Oulu University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
50 Years to 74 Years
Sex
All
01

Study 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. 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).

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Conditions studied

  • Lung Cancer Screening
03

In context

Lead sponsor

Oulu University Hospital is the lead sponsor of 39 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Smoking cessation application

    Device: Smoking cessation mobile application

  • Active comparator
    Written smoking cessation information

    Behavioral: Written material for smoking cessation

Interventions

  • DeviceSmoking cessation mobile application

    Mobile application for smoking cessation.

  • BehavioralWritten material for smoking cessation

    Written material for smoking cessation

06

What researchers measure

Primary outcomes

  1. Number of active smokers at 3 months

    The percentage of subjects who are actively smoking at 3 months after inclusion between the study arms

    Time frame: 3 months

Secondary outcomes

  1. 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

    Time frame: 3 months

  2. 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

    Time frame: 6 months

  3. 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.

    Time frame: 3 months

  4. 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.

    Time frame: 6 months

  5. 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.

    Time frame: 3 months

  6. 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.

    Time frame: 6 months

  7. 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.

    Time frame: At 2 years

  8. Costs related to CT screening including additional investigations

    The cumulative cost of diagnostic investigations per study subject.

    Time frame: At 2 years

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Study locations

2 sites
  • Oulu University Hospital
    Oulu, Finland
  • Vaasa Central Hospital
    Vaasa, Finland
08

References and documents

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 ↗

Individual participant data

Plan to share: No — National legislation does not make it possible to share clinical data.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05630950
Lead sponsor
Oulu University Hospital
Responsible party
Jussi Koivunen (MD PhD, Oulu University Hospital) — Principal investigator
First posted
Nov 30, 2022
Start date
Nov 18, 2022
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Aug 24, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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