Study of Early Cancer Biomarkers in Breath Condensate in Population of Individuals With High-Risk of Lung Cancer Undergoing LDCT Screening.

NCT06016569 | Recruiting DMC

• 1 other identifier: 60096
• Study Type: interventional
• Target: 3,200
• Locations: 1 country
• Sites: 3

Brief Summary

The trial will evaluate if the newly identified biomarkers of lung cancer in exhaled breath condensate are as a diagnostic tool comparable to the low-dose computer tomography (LDCT) implemented in lung cancer screening recently. Due to the possibility to collect breath condensate at any medical workplace and due to the relatively low financial cost of examination of the collected breath condensate could improve early diagnosis of lung cancer, differential diagnostics of lung nodules and thereby reduce both the unnecessary interventions and deaths from this type of cancer.

Conditions

Lung Cancer

Keywords

Lung Cancer; Breath Condensate; Biomarker; Screening; Early Cancer Detection

Outcome Measures

Primary Outcomes (3)

• Validation of the multiplex protein signature in exhaled air

  Validation of the multiplex protein signature in exhaled breath condensate based on the comparison with the LDCT.

  5 years

• Validation of the multiplex protein signature in exhaled breath for differential diagnostics of lung nodules

  Validation of the multiplex protein signature in exhaled breath for differential diagnostics of lung nodules

  5 years

• Assessment of the effectiveness of the screening program

  Assesment of the effectiveness of the screening procedure to reduce lung cancer mortality and overall mortality in the group with FEV1 (forced expiratory volume at 1 second) pre-bronchodilation 60-75% compared with the entire group of examinees.

  5 years

Secondary Outcomes (3)

• Total time of diagnosis of the nodule

  5 years

• Comparison of costs of screening procedures

  5 years

• Assessment of success of the anti-smoking intervention

  5 years

Other Outcomes (1)

• Number of newly captured interstitial lung processes

  5 years

Study Arms (1)

LDCT and collection of breath condensate and blood sample

EXPERIMENTAL

Each participant of the study will provide exhaled breath condensate sample and blood sample for further laboratory analyses. Each participant will have LDCT (low dose computer tomography) performed. A pulmonologist examines the patient for any concomitant diseases and performs spirometry. Vital signs will be measured.

Diagnostic Test: Exhaled breath condensate sampling; Diagnostic Test: Blood sampling; Procedure: LDCT; Diagnostic Test: Vital signs; Diagnostic Test: Spirometry

Interventions

LDCT PROCEDURE

LDCT scan will be performed.

Also known as: Low Dose Computer Tomography

LDCT and collection of breath condensate and blood sample

Exhaled breath condensate sampling DIAGNOSTIC_TEST

Patient will breath for approx. 10 minutes to a breath condenser. The exhaled breath sample will be condensed and freezed.

LDCT and collection of breath condensate and blood sample

Blood sampling DIAGNOSTIC_TEST

A venous blood sample will be taken for further biomarker analysis.

LDCT and collection of breath condensate and blood sample

Vital signs DIAGNOSTIC_TEST

Blood pressure, weight, height, pulse, oxygen saturation will be measured.

LDCT and collection of breath condensate and blood sample

Spirometry DIAGNOSTIC_TEST

Spirometry will be performed.

LDCT and collection of breath condensate and blood sample

Eligibility Criteria

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

You may qualify if:

• Consent to participate in a clinical trial.
• A clients within an age of 55-74 years.
• Current smoker or ex-smoker who has smoked at least 20 pack-years, provided that:
• priority will be given to clients who have smoked at least 30 pack-years.
• preference will be given to a former smoker who has not smoked for less than 15 years.

You may not qualify if:

• Previous diagnosis of lung cancer.
• Progressing malignant tumor on symptomatic treatment.
• Advanced dementia
• Chronic obstructive pulmonary disease or other inflammatory disease in the phase of acute exacerbation.

Sponsors & Collaborators

• Cancer Research Foundation CR: collaborator
• The Institute of Molecular and Translational Medicine, Czech Republic: lead

Study Sites (3)

Masaryk Memorial Cancer Institute

Brno, 65653, Czechia

RECRUITING

University Hospital

Olomouc, 77900, Czechia

NOT YET RECRUITING

General University Hospital in Prague

Prague, 12808, Czechia

NOT YET RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Blood Specimen Collection; Vital Signs; Spirometry

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Physical Examination; Respiratory Function Tests; Diagnostic Techniques, Respiratory System

Study Officials

• Marian Hajduch, MD, PhD.

  IMTM, Palacky University in Olomouc, Faculty of Medicine and Dentistry

  STUDY DIRECTOR

Central Study Contacts

Marian Hajduch, MD, PhD.

CONTACT

+420 585632083; marian.hajduch@upol.cz

Michaela Bendova, MSc.

CONTACT

+420585632050; michaela.bendova@upol.cz

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2023
• First Posted: August 29, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (3)