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

Study Overview
=================
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)

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

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Other: Response to pulmonary finding (nodule, mass)


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 74 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LDCT<br>Single arm - all patients undergo low-dose CT (LDCT) examination of lungs | Other: Response to pulmonary finding (nodule, mass)<br>* Follow-up low-dose CT, PET-CT, tissue sampling (transparietal biopsy, bronchoscopy, resection), contrast-enhanced CT of the thorax<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of cancers detected at stage I | 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 | 2023 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The cost per diagnosis at a resectable stage | 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). | 2023 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lung cancer, low dose CT