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

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

Interventions

DIAGNOSTIC_TEST

Exhaled breath condensate sampling

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

DIAGNOSTIC_TEST

Blood sampling

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

PROCEDURE

LDCT

LDCT scan will be performed.

DIAGNOSTIC_TEST

Vital signs

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

DIAGNOSTIC_TEST

Spirometry

Spirometry will be performed.

Sponsors & Collaborators

• Cancer Research Foundation CR

  collaborator UNKNOWN

• The Institute of Molecular and Translational Medicine, Czech Republic

  lead OTHER

Principal Investigators

• Marian Hajduch, MD, PhD. · IMTM, Palacky University in Olomouc, Faculty of Medicine and Dentistry

Study Design

Allocation

NA

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

55 Years

Max Age

74 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-06-01

Primary Completion

2029-12-31

Completion

2030-12-31

Countries

• Czechia

Study Locations