Clinical trial NCT06293833: Implementation of Lung Cancer Screening in the First Line Zone of ZORA (Flanders), Using a Low Dose CT-scan
Official title: Feasibility Study of Lung Cancer Screening in the Flemish Region, the ZORALCS Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Lung Cancer, Nonsmall Cell
Lung Cancer
Smoking Cessation
Lung Cancer, Small Cell
Keywords: Lung Cancer Screening
Lung Cancer
Smoking Cessation
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
name: Belgian Cancer Registry
First posted: 2024-03-05
Enrollment: 700
Sex: ALL
Minimum age (years): 55
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Participation rate of eligible high-risk (ex-)smokers in ELZ-ZORA
timeFrame: 2 years
Secondary outcomes:
measure: Responders
timeFrame: 2 years
measure: Number of true and false positive nodules
timeFrame: 2 years
measure: Impact of smoking cessation intervention
timeFrame: 2 years
measure: Success of smoking cessation intervention
timeFrame: 2 years
measure: Evaluation of shared decision making tool
timeFrame: 2 years
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: UZA
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Annemiek Snoeckx, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: