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

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Cancer Screening
• Intervention / Treatment: Device: Smoking cessation mobile application; Behavioral: Written material for smoking cessation

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Oulu, Finland
    • Oulu University Hospital
  • Vaasa, Finland
    • Vaasa Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smoking cessation application	Device: Smoking cessation mobile application; Mobile application for smoking cessation.
Active Comparator: Written smoking cessation information	Behavioral: Written material for smoking cessation; Written material for smoking cessation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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.	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.	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.	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.	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.	At 2 years
Costs related to CT screening including additional investigations	The cumulative cost of diagnostic investigations per study subject.	At 2 years

Collaborators and Investigators

• Sponsor: Oulu University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: November 18, 2022
• First Submitted That Met QC Criteria: November 18, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 22, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: EETTKM 21/2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: National legislation does not make it possible to share clinical data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No