Lung CancerELEGANCENCT04627350
Early Detection of Lung Cancer in Czech High-risk Asymptomatic Individuals
An observational study of Lung Cancer, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Response to pulmonary finding (nodule, mass)
- How many people
- 3,200 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Aug 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Defined by eligibility criteria
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
General University Hospital in Prague
Prague, 12808
Lukas Lambert, +420 224962232, lambert.lukas@gmail.com
About this study
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.
Read more
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
- Lung Cancer
- Being tested
- Response to pulmonary finding (nodule, mass)
- Keywords
- lung cancer, low dose CT
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| LDCT | Single arm - all patients undergo low-dose CT (LDCT) examination of lungs Receives: Other: Response to pulmonary finding (nodule, mass) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2023
Secondary outcomes (1)
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).
Measured: 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start1 Aug 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Charles University, Czech RepublicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Collaborators
- General University Hospital, Prague
- Responsible party
- Principal investigator, Lukas Lambert, General University Hospital, Prague
- Investigators
- Lukas Lambert, M.D., Principal investigator, General University Hospital, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627350
- Sponsor's protocol ID
- R01
- Acronym
- ELEGANCE
- Status last verified
- Nov 2020
- First submitted
- 27 Aug 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Lung Cancer in Czech High-risk Asymptomatic Individuals
- ClinicalTrials.gov ID
- NCT04627350
- Acronym / sponsor ID
- ELEGANCE / R01
- Conditions
- Lung Cancer
- Keywords
- lung cancer, low dose CT
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,200 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Collaborators
- General University Hospital, Prague
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LDCT | – | Other: Response to pulmonary finding (nodule, mass)Single arm - all patients undergo low-dose CT (LDCT) examination of lungs |
Who may qualify
- Ages
- 55 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Defined by eligibility criteria
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | LDCT |
Primary outcome
The number of cancers detected at stage I
Time frame: 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
1 secondary outcome
The cost per diagnosis at a resectable stage
Time frame: 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Individual participant dataSharing planned: No. There is no plan to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lukas Lambert, M.D. principal investigator
General University Hospital, Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lukas Lambert, M.D. (+420224962232, lambert.lukas@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of cancers detected at stage I (time frame: 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.