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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-18

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Lung Cancer Screening

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Smoking cessation application

Group Type EXPERIMENTAL

Smoking cessation mobile application

Intervention Type DEVICE

Mobile application for smoking cessation.

Written smoking cessation information

Group Type ACTIVE_COMPARATOR

Written material for smoking cessation

Intervention Type BEHAVIORAL

Written material for smoking cessation

Interventions

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Smoking cessation mobile application

Mobile application for smoking cessation.

Intervention Type DEVICE

Written material for smoking cessation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes