Early Detection of Lung Cancer in Czech High-risk Asymptomatic Individuals

Lung Cancer Clinical Trial

— ELEGANCE  

Official title:

Early Detection of Lung Cancer in Czech High-risk Asymptomatic Individuals

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04627350
• Other study ID #: R01
• Status: Recruiting
• Start date: August 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2020
• Source: Charles University, Czech Republic
• Contact: Lukas Lambert, M.D.
• Phone: +420224962232
• Email: lambert.lukas[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3200
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 74 Years

Eligibility

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)

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• 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

Locations

Country	Name	City	State
Czechia	General University Hospital in Prague	Prague

Sponsors (2)

Lead Sponsor	Collaborator
Charles University, Czech Republic	General University Hospital, Prague

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of secondary examinations	The number, cost, and complications of secondary examinations generated by screening LDCT.	2023
Other	Number of secondary findings	The number and types of secondary findings and their clinical relevance (potentially important vs. unimportant findings) will be reported.	2023
Primary	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
Secondary	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