Lung Cancer Clinical Trial
— ZORALCSOfficial title:
Feasibility Study of Lung Cancer Screening in the Flemish Region, the ZORALCS Study
Verified date | September 2023 |
Source | University Hospital, Antwerp |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Belgium | UZA | Edegem | Antwerp |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Antwerp | Belgian Cancer Registry, Universiteit Antwerpen |
Belgium,
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 |
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