Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2026-01-04 @ 7:21 AM
Study NCT ID:
NCT06537804
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-15
First Post:
2024-07-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Project Lung Cancer Screening in Southern Denmark
Sponsor:
Odense University Hospital
Organization:
Study Overview
Official Title:
Project Lung Cancer Screening in Southern Denmark
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-04
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:
PLUS
Brief Summary:
One thousand randomly selected voluntary citizens aged 60-74 years old, who are heavy current or former smokers with an increased risk of developing lung cancer may be included in the project. The participants will be identified through an initial questionnaire survey concerning smoking history and general health. Project participants are offered a low-dose CT (LDCT) scan annually for three consecutive years. In relation to the first scan, a lung function test will also be performed. The screening process will be evaluated for possible national implementation of a lung cancer screening program in Denmark.
Detailed Description:
This pilot study is a prospective interventional feasibility study. The primary goal is to evaluate the impact on healthcare organization, administration of resources and costs, and thereby assessing the feasibility of implementing systematic screening for lung cancer among people at high risk in Denmark (current or former heavy smokers). The pilot study will be performed on Funen in the Region of Southern Denmark and will run over three years (2024-2026). One thousand randomly selected participants aged 60-74 years old, who meet the screening criteria, will receive annual LDCT scans for three consecutive years.
Data will be collected continuously throughout the study period. The analysis method will focus on descriptive statistics to display questionnaire response and participation rates, and assess the impact of screening on healthcare organization and resources. Furthermore, the result including direct and indirect effects of the screening process (e.g. number of positive findings, false positive results, and follow-up rates). The analyses will also include healthcare economics including resource consumption as well as qualitative assessments to describe potential differences between the screening population versus a corresponding control group of heavy smokers. Finally, the radiologists' assessments of the project's LDCT scans are compared to the assessment of an artificially intelligent algorithm to explore the opportunities of supporting a future national screening program.
Data will be collected continuously throughout the study period. The analysis method will focus on descriptive statistics to display questionnaire response and participation rates, and assess the impact of screening on healthcare organization and resources. Furthermore, the result including direct and indirect effects of the screening process (e.g. number of positive findings, false positive results, and follow-up rates). The analyses will also include healthcare economics including resource consumption as well as qualitative assessments to describe potential differences between the screening population versus a corresponding control group of heavy smokers. Finally, the radiologists' assessments of the project's LDCT scans are compared to the assessment of an artificially intelligent algorithm to explore the opportunities of supporting a future national screening program.
Study Oversight
Has Oversight DMC:
False
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?: