Clinical trial · Observational
Early Detection of Lung Cancer in Czech High-risk Asymptomatic Individuals
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Response to pulmonary finding (nodule, mass) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- LDCT
- description
- Single arm - all patients undergo low-dose CT (LDCT) examination of lungs
- interventionNames
- Other: Response to pulmonary finding (nodule, mass)
Primary outcomes (1)
- measure
- The number of cancers detected at stage I
- timeFrame
- 2023
- description
- 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 outcomes (1)
- measure
- The cost per diagnosis at a resectable stage
- timeFrame
- 2023
- description
- 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).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 74 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available