Early Detection of Lung Cancer in Czech High-risk Asymptomatic Individuals

• Conditions: Lung Cancer
• Interventions: Other: Response to pulmonary finding (nodule, mass)

• Registration Number: NCT04627350
• Lead Sponsor: Charles University, Czech Republic

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-01
• Study First Submitted: 2020-08-27
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-07
• Last Update Submitted: 2020-11-07
• Study First Posted: 2020-11-13
• Last Update Posted: 2020-11-13
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3200

Inclusion Criteria

• Age 55-74 years
• Smoking: >= 30 pack-years, smoker or ex-smoker <15 years
• Performance status (0-1) - can climb at least one floor without any difficulty or pause

Exclusion Criteria

• Body weight above 140 kg
• Malignant disease within the last 10 years (except non-melanoma skin cancer).
• Chest CT less than one year ago
• Clinical signs suspicious of lung cancer (weight loss, new cough, hemoptysis)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LDCT	Response to pulmonary finding (nodule, mass)	Single arm - all patients undergo low-dose CT (LDCT) examination of lungs

Primary Outcome Measures

Name	Time	Method
The number of cancers detected at stage I	2023	The proportion of cancers diagnosed at a resectable stage (stage I) vs. non-resectable stage (II-IV) will be compared to the stage distribution in an unscreened population

Secondary Outcome Measures

Name	Time	Method
The cost per diagnosis at a resectable stage	2023	The cost per diagnosis at a resectable stage will encompass the cost of low-dose CT (LDCT), follow-up LDCT, verification (PET/CT, tissue sampling, bronchoscopy).

Trial Locations

Locations (1)

General University Hospital in Prague; 🇨🇿 Prague, Czechia