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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06016569




Registration number
NCT06016569
Ethics application status
Date submitted
22/08/2023
Date registered
29/08/2023

Titles & IDs
Public title
Study of Early Cancer Biomarkers in Breath Condensate in Population of Individuals with High-Risk of Lung Cancer Undergoing LDCT Screening.
Scientific title
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.
Secondary ID [1] 0 0
60096
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Diagnosis / Prognosis - Exhaled breath condensate sampling
Diagnosis / Prognosis - Blood sampling
Treatment: Surgery - LDCT
Diagnosis / Prognosis - Vital signs
Diagnosis / Prognosis - Spirometry

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.


Diagnosis / Prognosis: Exhaled breath condensate sampling
Patient will breath for approx. 10 minutes to a breath condenser. The exhaled breath sample will be condensed and freezed.

Diagnosis / Prognosis: Blood sampling
A venous blood sample will be taken for further biomarker analysis.

Treatment: Surgery: LDCT
LDCT scan will be performed.

Diagnosis / Prognosis: Vital signs
Blood pressure, weight, height, pulse, oxygen saturation will be measured.

Diagnosis / Prognosis: Spirometry
Spirometry will be performed.
Intervention code [1] 0 0
Diagnosis / Prognosis
Intervention code [2] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Validation of the multiplex protein signature in exhaled air
Timepoint [1] 0 0
5 years
Primary outcome [2] 0 0
Validation of the multiplex protein signature in exhaled breath for differential diagnostics of lung nodules
Timepoint [2] 0 0
5 years
Primary outcome [3] 0 0
Assessment of the effectiveness of the screening program
Timepoint [3] 0 0
5 years
Secondary outcome [1] 0 0
Total time of diagnosis of the nodule
Timepoint [1] 0 0
5 years
Secondary outcome [2] 0 0
Comparison of costs of screening procedures
Timepoint [2] 0 0
5 years
Secondary outcome [3] 0 0
Assessment of success of the anti-smoking intervention
Timepoint [3] 0 0
5 years

Eligibility
Key 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.
Minimum age
55 Years
Maximum age
74 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2030
Actual
Sample size
Target
3200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Czechia
State/province [1] 0 0
Brno
Country [2] 0 0
Czechia
State/province [2] 0 0
Olomouc
Country [3] 0 0
Czechia
State/province [3] 0 0
Praha

Funding & Sponsors
Primary sponsor type
Other
Name
The Institute of Molecular and Translational Medicine, Czech Republic
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Cancer Research Foundation CR
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Marian Hajduch, MD, PhD.
Address 0 0
IMTM, Palacky University in Olomouc, Faculty of Medicine and Dentistry
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Marian Hajduch, MD, PhD.
Address 0 0
Country 0 0
Phone 0 0
+420 585632083
Fax 0 0
Email 0 0
marian.hajduch@upol.cz
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06016569