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Trial Title:
LDCT-SC-FI Low-dose CT Screening for Lung Cancer
NCT ID:
NCT05630950
Condition:
Lung Cancer Screening
Conditions: Official terms:
Lung Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Smoking cessation mobile application
Description:
Mobile application for smoking cessation.
Arm group label:
Smoking cessation application
Intervention type:
Behavioral
Intervention name:
Written material for smoking cessation
Description:
Written material for smoking cessation
Arm group label:
Written smoking cessation information
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).
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
50 Years
Maximum age:
74 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Oulu University Hospital
Address:
City:
Oulu
Country:
Finland
Facility:
Name:
Vaasa Central Hospital
Address:
City:
Vaasa
Country:
Finland
Start date:
November 18, 2022
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Oulu University Hospital
Agency class:
Other
Source:
Oulu University Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05630950
