Early Detection of Lung Cancer in Czech High-risk Asymptomatic Individuals
NCT ID: NCT04627350
Last Updated: 2020-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
3200 participants
OBSERVATIONAL
2020-08-01
2023-12-31
Brief Summary
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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
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Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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LDCT
Single arm - all patients undergo low-dose CT (LDCT) examination of lungs
Response to pulmonary finding (nodule, mass)
Follow-up low-dose CT, PET-CT, tissue sampling (transparietal biopsy, bronchoscopy, resection), contrast-enhanced CT of the thorax
Interventions
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Response to pulmonary finding (nodule, mass)
Follow-up low-dose CT, PET-CT, tissue sampling (transparietal biopsy, bronchoscopy, resection), contrast-enhanced CT of the thorax
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
55 Years
74 Years
ALL
Yes
Sponsors
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General University Hospital, Prague
OTHER
Charles University, Czech Republic
OTHER
Responsible Party
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Lukas Lambert
Associated professor
Principal Investigators
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Lukas Lambert, M.D.
Role: PRINCIPAL_INVESTIGATOR
General University Hospital, Prague
Locations
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General University Hospital in Prague
Prague, , Czechia
Countries
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Central Contacts
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Facility Contacts
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Lukas Lambert
Role: primary
Other Identifiers
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R01
Identifier Type: -
Identifier Source: org_study_id