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

NCT05630950 | Active Not Recruiting DMC

• 1 other identifier: EETTKM 21/2022
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Lung Cancer Screening

Outcome Measures

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

  3 months

Secondary Outcomes (8)

• Number of subjects who have reduced the amount of smoked cigrattes/d at 3 months

  3 months

• Number of subjects who have reduced the amount of smoked cigrattes/d at 6 months

  6 months

• The reduction in number of smoked cigarettes/d at 3 months

  3 months

• The reduction in number of smoked cigarettes/d at 6 months

  6 months

• The percentage of reduction in number of smoked cigarettes/d at 3 months

  3 months

Study Arms (2)

Smoking cessation application

EXPERIMENTAL

Device: Smoking cessation mobile application

Written smoking cessation information

ACTIVE COMPARATOR

Behavioral: Written material for smoking cessation

Interventions

Smoking cessation mobile application DEVICE

Mobile application for smoking cessation.

Smoking cessation application

Written material for smoking cessation BEHAVIORAL

Written material for smoking cessation

Written smoking cessation information

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Oulu University Hospital: lead

Study Sites (2)

Oulu University Hospital

Oulu, Finland

Location

Vaasa Central Hospital

Vaasa, Finland

Location

Related Publications (1)

• 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.

  PMID: 39070744 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: November 30, 2022
• Study Start: November 18, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 24, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2)