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

Charles University, Czech Republic

Status: Unknown

Conditions: Lung Cancer

Treatments: Other: Response to pulmonary finding (nodule, mass)

Study type: Observational

Funder types: Other

Identifiers

NCT04627350

R01 (Other Grant/Funding Number)

Details and patient eligibility

About

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)

Enrollment: 3,200 estimated patients

Sex: All

Ages: 55 to 74 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

3,200 participants in 1 patient group

LDCT

Description:

Single arm - all patients undergo low-dose CT (LDCT) examination of lungs

Treatment:

Other: Response to pulmonary finding (nodule, mass)