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.

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Diagnostic test: Exhaled breath condensate sampling; Diagnostic test: Blood sampling; Procedure: LDCT; Diagnostic test: Vital signs; Diagnostic test: Spirometry

Detailed Description

The project aims to validate newly identified biomarkers of lung cancer in breath condensate for the diagnosis and triage of lung nodules (malignant versus benign), further set the mechanisms of the functioning of the lung cancer screening center, validate the quality indicators of LDCT screening for the Czech Republic and stratify the cohort of individuals so that optimized output of screening activities. Patients aged 55-74 years with a heavy smoking load (more than 20, preferably more than 30 pack/years) will be divided into risk groups according to biomarkers in exhaled air, clinical/anamnesis data and the degree of obstructive ventilation disorder according to spirometry and subsequently there will be effective stratification of the risk of lung carcinoma. The group with the highest risk of developing lung cancer will then be diagnosed with early lung cancer using ultra-low-dose computed tomography of the chest. This will lead to early diagnosis and subsequently to a reduction in the mortality rate of the monitored active group compared to the historical cohort. The primary outcome will be the validation of the multiplex protein signature in exhaled air, 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% with the entire group of examinees. The secondary outcome will then be the total time of diagnosis of a solitary pulmonary nodule in positively screened patients for whom only observation is not a sufficient procedure. Another secondary outcome will be the costs of screening procedures for individual groups and the percentage of success of the anti-smoking intervention for the enrolled individuals. The number of newly captured interstitial lung processes will also be evaluated. Patients will be evaluated for 5 years at annual visits or earlier based on their LDCT result.

• Study Type: Interventional
• Enrollment (Estimated): 3200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marian Hajduch, MD, PhD.; Phone Number: +420585632083; Email: marian.hajduch@upol.cz
• Study Contact Backup: Name: Michaela Bendova, MSc.; Phone Number: +420585632050; Email: michaela.bendova@upol.cz

Study Locations

• Czechia
  • Brno, Czechia, 65653
    • Recruiting
    • Masaryk Memorial Cancer Institute
    • Contact: Pavel Turcani, MD, PhD.; Phone Number: +420543136409; Email: pavel.turcani@mou.cz
    • Contact: Martina Lojova, MSc., PhD.; Phone Number: +420543136132; Email: martina.lojova@mou.cz
  • Olomouc, Czechia, 77900
    • Not yet recruiting
    • University Hospital
    • Contact: Petr Jakubec, MD, PhD.; Phone Number: +420588445918; Email: petr.jakubec@fnol.cz
    • Contact: Miroslav Herman, prof.MD PhD.; Phone Number: +420588443495; Email: miroslav.herman@fnol.cz
  • Praha, Czechia, 12808
    • Not yet recruiting
    • General University Hospital in Prague
    • Contact: Jiri Votruba, MD, Ph.D.; Phone Number: +420 224 969 355; Email: jiri.votruba@vfn.cz
    • Contact: Lenka Navratova, MD; Phone Number: +420224969352; Email: lenka.navratova@vfn.cz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Consent to participate in a clinical trial.
2. A clients within an age of 55-74 years.

3. Current smoker or ex-smoker who has smoked at least 20 pack-years, provided that:

   1. priority will be given to clients who have smoked at least 30 pack-years.
   2. preference will be given to a former smoker who has not smoked for less than 15 years.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

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.; Other Names: Low Dose Computer Tomography; Diagnostic test: Vital signs; Blood pressure, weight, height, pulse, oxygen saturation will be measured.; Diagnostic test: Spirometry; Spirometry will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total time of diagnosis of the nodule	The total time of diagnosis of a solitary pulmonary nodule in positively screened patients for whom only observation is not a sufficient procedure.	5 years
Comparison of costs of screening procedures	Comparison of the costs of the screening procedures for exhaled breath condensate sample and LDCT procedure. This will be asssessed based on the individula patient data: total screening costs per patient from Healthcare registry in Czech Republic.	5 years
Assessment of success of the anti-smoking intervention	Percentage success of the anti-smoking intervention in the examined probands.	5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of newly captured interstitial lung processes	The number of newly captured interstitial lung processes will also be evaluated.	5 years

Collaborators and Investigators

• Sponsor: The Institute of Molecular and Translational Medicine, Czech Republic
• Collaborators: Cancer Research Foundation CR
• Investigators: Study Director: Marian Hajduch, MD, PhD., IMTM, Palacky University in Olomouc, Faculty of Medicine and Dentistry

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 1, 2030

Study Registration Dates

• First Submitted: August 22, 2023
• First Submitted That Met QC Criteria: August 28, 2023
• First Posted (Actual): August 29, 2023

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 28, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Biomarker; Lung Cancer; Screening; Early Cancer Detection; Breath Condensate
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 60096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No