Implementation of Lung Cancer Screening in the First Line Zone of ZORA (Flanders), Using a Low Dose CT-scan

University Hospital, Antwerp700 enrolled

Overview

The goal of this clinical trial is to implement lung cancer screening in a targeted high-risk population of heavy (ex-)smokers in Flanders (Belgium). This implementation study will investigate the participation rate of eligible high risk (ex-)smokers in the First Line Zone South East Region of Antwerp (ZORA) in a LDCT screening program, combined with smoking cessation.

A four year prospective non-randomized feasibility implementation study for lung cancer screening in a targeted high-risk population of heavy (ex-)smokers by low-dose CT, combined with a smoking cessation intervention. It will be coordinated by a consortium of researchers from UZA and UAntwerpen. Lung cancer (LC) remains the leading cause of cancer mortality, worldwide and in Belgium. Prevention and early detection are considered the cornerstones to increase the chances of successful treatment and improved outcomes. There is strong scientific evidence that screening for lung cancer through an annual low-dose CT scan (LDCT) in a high-risk population of (ex-)smokers significantly reduces lung cancer mortality and is cost-effective. This implementation study will investigate the participation rate of eligible high risk (ex-)smokers in the First Line Zone (ELZ) South East Region of Antwerp (ZORA) in a LDCT screening program, combined with smoking cessation. Besides, other indicators of compliance, quality and turn-around-time will be estimated. It will give insights in the feasibility and potential challenges of implementing a LDCT lung cancer screening program in our region. This implementation project is in line with the European Commission Council recommendation of December 2022 to explore the feasibility and effectiveness of LDCT in a high-risk population. Findings from this study will contribute valuable evidence for policymakers and stakeholders. Furthermore, an implementation pilot is a prerequisite for a future high-quality population-based screening program.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Conditions

Lung Cancer, Nonsmall Cell Lung Cancer Smoking Cessation Lung Cancer, Small Cell

Interventions

Low-dose CT scanRADIATION

Participants get an annual low-dose CT scan in UZA

Smoking CessationBEHAVIORAL

Smoking cessation campagnes

Eligibility

Sex: ALLMin age: 55 YearsMax age: 74 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: The target population consists of all adult inhabitants from the following municipalities of the ELZ ZORA: Mortsel (2640), Edegem (2650), Boechout (2530), Kontich (2550), Lint (2547), Hove (2540), and having a (TBA) % risk of developing an incidental lung cancer in the following 6 years (calculated a by risk prediction model) 1. Males and females 2. 55 -74 years old 3. Fitness for any kind of curative therapy for lung cancer 4. Absence of prior (lung) cancer in the 5 preceding years (excluding skin basal cell carcinoma and early stage cervical cancer) 5. Having a GP or related trusted health care provider Exclusion Criteria: 1. participant may not have any symptoms (cough, pain when breathing in...) 2. Body weight \>140 kg in view of the maximum charge of the CT-scan table 3. The (rare) hereditary Li-Fraumeni syndrome which gives the carriers an excess risk of X-ray induced oncogenesis

Locations (1)

UZA

Edegem, Antwerp, Belgium

Outcomes

Primary Outcomes

Participation rate of eligible high-risk (ex-)smokers in ELZ-ZORA

Enrollment rate of eligible responders attending at least one LDCT procedure - Measured by descriptive statistics (discrete data)

Time frame: 2 years

Secondary Outcomes

Responders

Number of candidates responding to the invitation - measured by descriptive statistics (discrete data)

Time frame: 2 years

Number of true and false positive nodules

Number of true and false positive nodules detected irequiring further work-up. Measured by descriptive statistics (discrete data)

Time frame: 2 years

Impact of smoking cessation intervention

Number of smoking participants having attended a smoking cessation intervention. Measured by descriptive statistics (discrete data)

Time frame: 2 years

Success of smoking cessation intervention

Number of smoking participants having quit smoking 1 year after enrollment. Measured by descriptive statistics (discrete data)

Time frame: 2 years

Evaluation of shared decision making tool

Evaluation of shared decision making tool by a questionnaire

Time frame: 2 years

Data from ClinicalTrials.gov

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