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Trial Title:
Implementation of Lung Cancer Screening in the First Line Zone of ZORA (Flanders), Using a Low Dose CT-scan
NCT ID:
NCT06293833
Condition:
Lung Cancer, Nonsmall Cell
Lung Cancer
Smoking Cessation
Lung Cancer, Small Cell
Conditions: Official terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Conditions: Keywords:
Lung Cancer Screening
Lung Cancer
Smoking Cessation
Study type:
Interventional
Study phase:
N/A
Overall status:
Enrolling by invitation
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Low-dose CT scan
Description:
Participants get an annual low-dose CT scan in UZA
Arm group label:
High-risk (ex-) smokers
Intervention type:
Behavioral
Intervention name:
Smoking Cessation
Description:
Smoking cessation campagnes
Arm group label:
High-risk (ex-) smokers
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.
Criteria for 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
Gender:
All
Minimum age:
55 Years
Maximum age:
74 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
UZA
Address:
City:
Edegem
Zip:
2650
Country:
Belgium
Start date:
September 1, 2024
Completion date:
January 1, 2026
Lead sponsor:
Agency:
University Hospital, Antwerp
Agency class:
Other
Collaborator:
Agency:
Universiteit Antwerpen
Agency class:
Other
Collaborator:
Agency:
Belgian Cancer Registry
Agency class:
Other
Source:
University Hospital, Antwerp
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06293833
