Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-31 @ 2:59 PM
Study NCT ID:
NCT06293833
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-05
First Post:
2024-02-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementation of Lung Cancer Screening in the First Line Zone of ZORA (Flanders), Using a Low Dose CT-scan
Sponsor:
University Hospital, Antwerp
Organization:
Study Overview
Official Title:
Feasibility Study of Lung Cancer Screening in the Flemish Region, the ZORALCS Study
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ZORALCS
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: