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

NCT04627350 | Unknown

• 1 other identifier: R01
• Study Type: observational
• Target: 3,200
• Locations: 1 country
• Sites: 1

Brief 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

Lung Cancer

Keywords

lung cancer; low dose CT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The cost per diagnosis at a resectable stage

  2023

Other Outcomes (2)

• Number of secondary examinations

  2023

• Number of secondary findings

  2023

Study Arms (1)

LDCT

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

Other: Response to pulmonary finding (nodule, mass)

Interventions

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

LDCT

Eligibility Criteria

• Age: 55 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Defined by eligibility criteria

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• General University Hospital, Prague: collaborator

Study Sites (1)

General University Hospital in Prague

Prague, 12808, Czechia

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Fibrillins

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins; Extracellular Matrix Proteins; Scleroproteins

Study Officials

• Lukas Lambert, M.D.

  General University Hospital, Prague

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lukas Lambert, M.D.

CONTACT

+420224962232; lambert.lukas@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated professor

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: November 13, 2020
• Study Start: August 1, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)