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

NCT04627350 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 3200

Last updated 2020-11-13

No results posted yet for this study

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)

Conditions

Interventions

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

Sponsors & Collaborators

  • General University Hospital, Prague

    collaborator OTHER

  • Charles University, Czech Republic

    lead OTHER

Principal Investigators

  • Lukas Lambert, M.D. · General University Hospital, Prague

Eligibility

Min Age
55 Years
Max Age
74 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-01
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Czechia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04627350 on ClinicalTrials.gov