Lung Cancer, Nonsmall CellZORALCSNCT06293833
Implementation of Lung Cancer Screening in the First Line Zone of ZORA (Flanders), Using a Low Dose CT-scan
A study testing Low-dose CT scan and Smoking Cessation in people with Lung Cancer, Nonsmall Cell and Lung Cancer, run by University Hospital, Antwerp at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 55 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer, Nonsmall Cell, Lung Cancer, Smoking Cessation
- What is being tested?
- Low-dose CT scan and Smoking Cessation
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Sep 2024to 1 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
- Males and females
- 55 -74 years old
- Fitness for any kind of curative therapy for lung cancer
- Absence of prior (lung) cancer in the 5 preceding years (excluding skin basal cell carcinoma and early stage cervical cancer)
- Having a GP or related trusted health care provider
Who cannot join
- participant may not have any symptoms (cough, pain when breathing in...)
- Body weight >140 kg in view of the maximum charge of the CT-scan table
- The (rare) hereditary Li-Fraumeni syndrome which gives the carriers an excess risk of X-ray induced oncogenesis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility Study of Lung Cancer Screening in the Flemish Region, the ZORALCS Study
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.
Read the 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.
- Being tested
- Low-dose CT scan, Smoking Cessation
- Keywords
- Lung Cancer Screening, Lung Cancer, Smoking Cessation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Smoking Cessation, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-dose CT scanRadiation
Participants get an annual low-dose CT scan in UZA
Smoking CessationBehavioural
Smoking cessation campagnes
| Study group | Role | What they receive |
|---|---|---|
| High-risk (ex-) smokers | Experimental | Prevention and early detection of lung cancer 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. Receives: Radiation: Low-dose CT scan; Behavioral: Smoking Cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 years
Secondary outcomes (5)
Responders
Number of candidates responding to the invitation - measured by descriptive statistics (discrete data)
Measured: 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)
Measured: 2 years
Impact of smoking cessation intervention
Number of smoking participants having attended a smoking cessation intervention. Measured by descriptive statistics (discrete data)
Measured: 2 years
Success of smoking cessation intervention
Number of smoking participants having quit smoking 1 year after enrollment. Measured by descriptive statistics (discrete data)
Measured: 2 years
Evaluation of shared decision making tool
Evaluation of shared decision making tool by a questionnaire
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start1 Sep 2024 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer, Nonsmall CellStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen, Belgian Cancer Registry
- Responsible party
- Sponsor
- Investigators
- Annemiek Snoeckx, MD, PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293833
- Sponsor's protocol ID
- 003315
- Acronym
- ZORALCS
- Status last verified
- Sep 2023
- First submitted
- 19 Feb 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Lung Cancer Screening in the Flemish Region, the ZORALCS Study
- ClinicalTrials.gov ID
- NCT06293833
- Acronym / sponsor ID
- ZORALCS / 003315
- Keywords
- Lung Cancer Screening, Lung Cancer, Smoking Cessation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen, Belgian Cancer Registry
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2026 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-risk (ex-) smokers | Experimental | Radiation: Low-dose CT scan, Behavioral: Smoking CessationPrevention and early detection of lung cancer 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. |
Who may qualify
- Ages
- 55 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
- Males and females
- 55 -74 years old
- Fitness for any kind of curative therapy for lung cancer
- Absence of prior (lung) cancer in the 5 preceding years (excluding skin basal cell carcinoma and early stage cervical cancer)
Key exclusion criteria (3 listed)
- participant may not have any symptoms (cough, pain when breathing in...)
- Body weight >140 kg in view of the maximum charge of the CT-scan table
- The (rare) hereditary Li-Fraumeni syndrome which gives the carriers an excess risk of X-ray induced oncogenesis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-dose CT scanParticipants get an annual low-dose CT scan in UZA | Radiation | High-risk (ex-) smokers |
| Smoking CessationSmoking cessation campagnes | Behavioural | High-risk (ex-) smokers |
Primary outcome
Participation rate of eligible high-risk (ex-)smokers in ELZ-ZORA
Time frame: 2 years
Enrollment rate of eligible responders attending at least one LDCT procedure - Measured by descriptive statistics (discrete data)
5 secondary outcomes
Responders
Time frame: 2 years
Number of true and false positive nodules
Time frame: 2 years
Impact of smoking cessation intervention
Time frame: 2 years
Success of smoking cessation intervention
Time frame: 2 years
Evaluation of shared decision making tool
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Annemiek Snoeckx, MD, PhD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-dose CT scan and Smoking Cessation in people with Lung Cancer, Nonsmall Cell and Lung Cancer, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation rate of eligible high-risk (ex-)smokers in ELZ-ZORA (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.