Trial Title:
Study of Early Cancer Biomarkers in Breath Condensate in Population of Individuals with High-Risk of Lung Cancer Undergoing LDCT Screening.
NCT ID:
NCT06016569
Condition:
Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Conditions: Keywords:
Lung Cancer
Breath Condensate
Biomarker
Screening
Early Cancer Detection
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Exhaled breath condensate sampling
Description:
Patient will breath for approx. 10 minutes to a breath condenser. The exhaled breath
sample will be condensed and freezed.
Arm group label:
LDCT and collection of breath condensate and blood sample
Intervention type:
Diagnostic Test
Intervention name:
Blood sampling
Description:
A venous blood sample will be taken for further biomarker analysis.
Arm group label:
LDCT and collection of breath condensate and blood sample
Intervention type:
Procedure
Intervention name:
LDCT
Description:
LDCT scan will be performed.
Arm group label:
LDCT and collection of breath condensate and blood sample
Other name:
Low Dose Computer Tomography
Intervention type:
Diagnostic Test
Intervention name:
Vital signs
Description:
Blood pressure, weight, height, pulse, oxygen saturation will be measured.
Arm group label:
LDCT and collection of breath condensate and blood sample
Intervention type:
Diagnostic Test
Intervention name:
Spirometry
Description:
Spirometry will be performed.
Arm group label:
LDCT and collection of breath condensate and blood sample
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.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
55 Years
Maximum age:
74 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Masaryk Memorial Cancer Institute
Address:
City:
Brno
Zip:
65653
Country:
Czechia
Status:
Recruiting
Contact:
Last name:
Pavel Turcani, MD, PhD.
Phone:
+420543136409
Email:
pavel.turcani@mou.cz
Contact backup:
Last name:
Martina Lojova, MSc., PhD.
Phone:
+420543136132
Email:
martina.lojova@mou.cz
Facility:
Name:
University Hospital
Address:
City:
Olomouc
Zip:
77900
Country:
Czechia
Status:
Not yet recruiting
Contact:
Last name:
Petr Jakubec, MD, PhD.
Phone:
+420588445918
Email:
petr.jakubec@fnol.cz
Contact backup:
Last name:
Miroslav Herman, prof.MD PhD.
Phone:
+420588443495
Email:
miroslav.herman@fnol.cz
Facility:
Name:
General University Hospital in Prague
Address:
City:
Praha
Zip:
12808
Country:
Czechia
Status:
Not yet recruiting
Contact:
Last name:
Jiri Votruba, MD, Ph.D.
Phone:
+420 224 969 355
Email:
jiri.votruba@vfn.cz
Contact backup:
Last name:
Lenka Navratova, MD
Phone:
+420224969352
Email:
lenka.navratova@vfn.cz
Start date:
June 1, 2023
Completion date:
December 2030
Lead sponsor:
Agency:
The Institute of Molecular and Translational Medicine, Czech Republic
Agency class:
Other
Collaborator:
Agency:
Cancer Research Foundation CR
Agency class:
Other
Source:
The Institute of Molecular and Translational Medicine, Czech Republic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06016569
