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

November 7, 2020 updated by: Lukas Lambert, Charles University, Czech Republic

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

3200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Czechia
      • Prague, Czechia, 12808
        • Recruiting
        • General University Hospital in Prague
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Defined by eligibility criteria

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
LDCT
Single arm - all patients undergo low-dose CT (LDCT) examination of lungs
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
2023

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The cost per diagnosis at a resectable stage
Time Frame: 2023
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of secondary examinations
Time Frame: 2023
The number, cost, and complications of secondary examinations generated by screening LDCT.
2023
Number of secondary findings
Time Frame: 2023
The number and types of secondary findings and their clinical relevance (potentially important vs. unimportant findings) will be reported.
2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Collaborators

General University Hospital, Prague

Investigators

  • Principal Investigator: Lukas Lambert, M.D., General University Hospital in Prague

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2020

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

August 27, 2020

First Submitted That Met QC Criteria

November 7, 2020

First Posted (ACTUAL)

November 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 7, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01 (Other Grant/Funding Number: HL079916)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share individual participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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