Lung Cancer
Conditions
Keywords
lung cancer, low dose CT
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)
Interventions
OTHERResponse to pulmonary finding (nodule, mass)
Follow-up low-dose CT, PET-CT, tissue sampling (transparietal biopsy, bronchoscopy, resection), contrast-enhanced CT of the thorax
Sponsors
General University Hospital, Prague
Charles University, Czech Republic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
55 Years to 74 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of secondary examinations | 2023 | The number, cost, and complications of secondary examinations generated by screening LDCT. |
| Number of secondary findings | 2023 | The number and types of secondary findings and their clinical relevance (potentially important vs. unimportant findings) will be reported. |
Countries
Czechia
Contacts
Primary ContactLukas Lambert, M.D.
Outcome results
None listed