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.

Status: Recruiting
Intervention Type: Diagnostic test, Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 55
Maximum Age: 74
Healthy Volunteers: t
View:

• 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.

Contact Information
Primary
Marian Hajduch, MD, PhD.
marian.hajduch@upol.cz
+420 585632083
Backup
Michaela Bendova, MSc.
michaela.bendova@upol.cz
+420585632050
Time Frame
Start Date: 2023-06-01
Estimated Completion Date: 2030-12
Participants
Target number of participants: 3200
Treatments
Experimental: LDCT and collection of breath condensate and blood sample
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.
Related Therapeutic Areas
Sponsors
Leads: The Institute of Molecular and Translational Medicine, Czech Republic
Collaborators: Cancer Research Foundation CR

This content was sourced from clinicaltrials.gov

Similar Clinical Trials