Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06537804
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-01
Brief Title:
Project Lung Cancer Screening in Southern Denmark
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Project Lung Cancer Screening in Southern Denmark
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 eg 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 projects 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 eg 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 projects 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None