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| Name | Class |
|---|---|
| General University Hospital, Prague | OTHER |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDCT | Single arm - all patients undergo low-dose CT (LDCT) examination of lungs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Response to pulmonary finding (nodule, mass) | Other | Follow-up low-dose CT, PET-CT, tissue sampling (transparietal biopsy, bronchoscopy, resection), contrast-enhanced CT of the thorax |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of secondary examinations | The number, cost, and complications of secondary examinations generated by screening LDCT. | 2023 |
| Number of secondary findings | The number and types of secondary findings and their clinical relevance (potentially important vs. unimportant findings) will be reported. |
Inclusion Criteria:
Exclusion Criteria:
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Defined by eligibility criteria
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lukas Lambert, M.D. | Contact | +420224962232 | lambert.lukas@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Lukas Lambert, M.D. | General University Hospital, Prague | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General University Hospital in Prague | Recruiting | Prague | 12808 | Czechia |
There is no plan to share individual participant data.
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000071837 | Fibrillins |
| ID | Term |
|---|---|
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011506 | Proteins |
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| 2023 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D016326 | Extracellular Matrix Proteins |
| D012596 | Scleroproteins |