RecruitingNot ApplicableNCT06016569

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

Prospective Validation Study of Early Cancer Biomarkers in Breath Condensate of Individuals With High-Risk of Lung Cancer Undergoing Low-Dose Computer Tomography Based Screening.


Sponsor

The Institute of Molecular and Translational Medicine, Czech Republic

Enrollment

3,200 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 55 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This trial tests whether exhaled breath condensate (a sample from your breath) can help detect early signs of lung cancer in high-risk smokers already getting CT scan screenings. You may be eligible if... - You are between 55 and 74 years old - You are a current smoker or have smoked at least 20 pack-years (with priority for those with 30+ pack-years) - If you are a former smoker, you quit less than 15 years ago You may NOT be eligible if... - You have previously been diagnosed with lung cancer - You have another cancer being actively treated with palliative care only - You have advanced dementia - You have COPD or another lung inflammatory disease currently in a flare-up Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTExhaled breath condensate sampling

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

DIAGNOSTIC_TESTBlood sampling

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

PROCEDURELDCT

LDCT scan will be performed.

DIAGNOSTIC_TESTVital signs

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

DIAGNOSTIC_TESTSpirometry

Spirometry will be performed.


Locations(3)

Masaryk Memorial Cancer Institute

Brno, Czechia

University Hospital

Olomouc, Czechia

General University Hospital in Prague

Prague, Czechia

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NCT06016569


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