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

Lung Cancer Clinical Trial

— ZORALCS  

Official title:

Feasibility Study of Lung Cancer Screening in the Flemish Region, the ZORALCS Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06293833
• Other study ID #: 003315
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 1, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: September 2023
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 700
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Cancer
• Lung Cancer, Nonsmall Cell
• Lung Cancer, Small Cell
• Lung Neoplasms
• Small Cell Lung Carcinoma
• Smoking Cessation

Intervention

Radiation:
• Low-dose CT scan
Participants get an annual low-dose CT scan in UZA

Behavioral:
• Smoking Cessation
Smoking cessation campagnes

Locations

Country	Name	City	State
Belgium	UZA	Edegem	Antwerp

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Belgian Cancer Registry, Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	2 years
Secondary	Responders	Number of candidates responding to the invitation - measured by descriptive statistics (discrete data)	2 years
Secondary	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)	2 years
Secondary	Impact of smoking cessation intervention	Number of smoking participants having attended a smoking cessation intervention. Measured by descriptive statistics (discrete data)	2 years
Secondary	Success of smoking cessation intervention	Number of smoking participants having quit smoking 1 year after enrollment. Measured by descriptive statistics (discrete data)	2 years
Secondary	Evaluation of shared decision making tool	Evaluation of shared decision making tool by a questionnaire	2 years