Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-29 @ 2:23 AM
Study NCT ID:
NCT04627350
Status:
UNKNOWN
Last Update Posted:
2020-11-13
First Post:
2020-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Detection of Lung Cancer in Czech High-risk Asymptomatic Individuals
Sponsor:
Charles University, Czech Republic
Organization:
Study Overview
Official Title:
Early Detection of Lung Cancer in Czech High-risk Asymptomatic Individuals
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
RECRUITING
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:
ELEGANCE
Brief Summary:
The aim of this study is to evaluate and optimize entry criteria for the proposed programme for early detection of lung cancer in the Czech Republic.
An estimated 3200 high-risk (age 55-74 years, \>30 pack-years) asymptomatic individuals will undergo baseline low-dose chest CT (LDCT) and a follow-up LDCT at 1 year. Patients with poor performance status (PS) 2-4, history of malignancy in the past 10 years, chest CT in the past 1 year, bodyweight \>140kg will not be included.
The patients will fill out a questionnaire with basic data, including smoking history (pack-years), history of previous malignancy, CT imaging of the thorax, and will undergo spirometry.
Outcomes of the study include:
* optimization of entry criteria, optimization of timing of a follow-up LDCT and management of the patients, proposal of quality assurance indicators
* influence of screening on the stage of lung cancer at the time of the diagnosis and life-years lost
* cost-effectiveness of the screening program
* evaluation of the diagnostic yield for secondary findings (pulmonary fibrosis, cardiovascular risk)
An estimated 3200 high-risk (age 55-74 years, \>30 pack-years) asymptomatic individuals will undergo baseline low-dose chest CT (LDCT) and a follow-up LDCT at 1 year. Patients with poor performance status (PS) 2-4, history of malignancy in the past 10 years, chest CT in the past 1 year, bodyweight \>140kg will not be included.
The patients will fill out a questionnaire with basic data, including smoking history (pack-years), history of previous malignancy, CT imaging of the thorax, and will undergo spirometry.
Outcomes of the study include:
* optimization of entry criteria, optimization of timing of a follow-up LDCT and management of the patients, proposal of quality assurance indicators
* influence of screening on the stage of lung cancer at the time of the diagnosis and life-years lost
* cost-effectiveness of the screening program
* evaluation of the diagnostic yield for secondary findings (pulmonary fibrosis, cardiovascular risk)
Detailed Description:
None
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?: