xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06016569</url>
    </required_header>
    <id_info>
      <org_study_id>60096</org_study_id>
      <nct_id>NCT06016569</nct_id>
    </id_info>
    <brief_title>Study of Early Cancer Biomarkers in Breath Condensate in Population of Individuals With High-Risk of Lung Cancer Undergoing LDCT Screening.</brief_title>
    <official_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.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The Institute of Molecular and Translational Medicine, Czech Republic</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Cancer Research Foundation CR</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>The Institute of Molecular and Translational Medicine, Czech Republic</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The trial will evaluate if the newly identified biomarkers of lung cancer in exhaled breath&#xD;
        condensate are as a diagnostic tool comparable to the low-dose computer tomography (LDCT)&#xD;
        implemented in lung cancer screening recently. Due to the possibility to collect breath&#xD;
        condensate at any medical workplace and due to the relatively low financial cost of&#xD;
        examination of the collected breath condensate could improve early diagnosis of lung cancer,&#xD;
        differential diagnostics of lung nodules and thereby reduce both the unnecessary&#xD;
        interventions and deaths from this type of cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The project aims to validate newly identified biomarkers of lung cancer in breath condensate&#xD;
        for the diagnosis and triage of lung nodules (malignant versus benign), further set the&#xD;
        mechanisms of the functioning of the lung cancer screening center, validate the quality&#xD;
        indicators of LDCT screening for the Czech Republic and stratify the cohort of individuals so&#xD;
        that optimized output of screening activities. Patients aged 55-74 years with a heavy smoking&#xD;
        load (more than 20, preferably more than 30 pack/years) will be divided into risk groups&#xD;
        according to biomarkers in exhaled air, clinical/anamnesis data and the degree of obstructive&#xD;
        ventilation disorder according to spirometry and subsequently there will be effective&#xD;
        stratification of the risk of lung carcinoma. The group with the highest risk of developing&#xD;
        lung cancer will then be diagnosed with early lung cancer using ultra-low-dose computed&#xD;
        tomography of the chest. This will lead to early diagnosis and subsequently to a reduction in&#xD;
        the mortality rate of the monitored active group compared to the historical cohort. The&#xD;
        primary outcome will be the validation of the multiplex protein signature in exhaled air, the&#xD;
        effectiveness of the screening procedure to reduce lung cancer mortality and overall&#xD;
        mortality in the group with FEV1 (forced expiratory volume at 1 second) pre-bronchodilation&#xD;
        60-75% with the entire group of examinees. The secondary outcome will then be the total time&#xD;
        of diagnosis of a solitary pulmonary nodule in positively screened patients for whom only&#xD;
        observation is not a sufficient procedure. Another secondary outcome will be the costs of&#xD;
        screening procedures for individual groups and the percentage of success of the anti-smoking&#xD;
        intervention for the enrolled individuals. The number of newly captured interstitial lung&#xD;
        processes will also be evaluated. Patients will be evaluated for 5 years at annual visits or&#xD;
        earlier based on their LDCT result.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 1, 2023</start_date>
    <completion_date type="Anticipated">December 2030</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2029</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Screening</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Validation of the multiplex protein signature in exhaled air</measure>
      <time_frame>5 years</time_frame>
      <description>Validation of the multiplex protein signature in exhaled breath condensate based on the comparison with the LDCT.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Validation of the multiplex protein signature in exhaled breath for differential diagnostics of lung nodules</measure>
      <time_frame>5 years</time_frame>
      <description>Validation of the multiplex protein signature in exhaled breath for differential diagnostics of lung nodules</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of the effectiveness of the screening program</measure>
      <time_frame>5 years</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Total time of diagnosis of the nodule</measure>
      <time_frame>5 years</time_frame>
      <description>The total time of diagnosis of a solitary pulmonary nodule in positively screened patients for whom only observation is not a sufficient procedure.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Comparison of costs of screening procedures</measure>
      <time_frame>5 years</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Assessment of success of the anti-smoking intervention</measure>
      <time_frame>5 years</time_frame>
      <description>Percentage success of the anti-smoking intervention in the examined probands.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Number of newly captured interstitial lung processes</measure>
      <time_frame>5 years</time_frame>
      <description>The number of newly captured interstitial lung processes will also be evaluated.</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">3200</enrollment>
    <condition>Lung Cancer</condition>
    <arm_group>
      <arm_group_label>LDCT and collection of breath condensate and blood sample</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Exhaled breath condensate sampling</intervention_name>
      <description>Patient will breath for approx. 10 minutes to a breath condenser. The exhaled breath sample will be condensed and freezed.</description>
      <arm_group_label>LDCT and collection of breath condensate and blood sample</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Blood sampling</intervention_name>
      <description>A venous blood sample will be taken for further biomarker analysis.</description>
      <arm_group_label>LDCT and collection of breath condensate and blood sample</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>LDCT</intervention_name>
      <description>LDCT scan will be performed.</description>
      <arm_group_label>LDCT and collection of breath condensate and blood sample</arm_group_label>
      <other_name>Low Dose Computer Tomography</other_name>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Vital signs</intervention_name>
      <description>Blood pressure, weight, height, pulse, oxygen saturation will be measured.</description>
      <arm_group_label>LDCT and collection of breath condensate and blood sample</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Spirometry</intervention_name>
      <description>Spirometry will be performed.</description>
      <arm_group_label>LDCT and collection of breath condensate and blood sample</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Consent to participate in a clinical trial.&#xD;
  &#xD;
            2. A clients within an age of 55-74 years.&#xD;
  &#xD;
            3. Current smoker or ex-smoker who has smoked at least 20 pack-years, provided that:&#xD;
  &#xD;
                 1. priority will be given to clients who have smoked at least 30 pack-years.&#xD;
  &#xD;
                 2. preference will be given to a former smoker who has not smoked for less than 15&#xD;
                    years.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Previous diagnosis of lung cancer.&#xD;
  &#xD;
            2. Progressing malignant tumor on symptomatic treatment.&#xD;
  &#xD;
            3. Advanced dementia&#xD;
  &#xD;
            4. Chronic obstructive pulmonary disease or other inflammatory disease in the phase of&#xD;
               acute exacerbation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>55 Years</minimum_age>
      <maximum_age>74 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Marian Hajduch, MD, PhD.</last_name>
      <role>Study Director</role>
      <affiliation>IMTM, Palacky University in Olomouc, Faculty of Medicine and Dentistry</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Marian Hajduch, MD, PhD.</last_name>
      <phone>+420585632083</phone>
      <email>marian.hajduch@upol.cz</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Michaela Bendova, MSc.</last_name>
      <phone>+420585632050</phone>
      <email>michaela.bendova@upol.cz</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Masaryk Memorial Cancer Institute</name>
        <address>
          <city>Brno</city>
          <zip>65653</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Pavel Turcani, MD, PhD.</last_name>
        <phone>+420543136409</phone>
        <email>pavel.turcani@mou.cz</email>
      </contact>
      <contact_backup>
        <last_name>Martina Lojova, MSc., PhD.</last_name>
        <phone>+420543136132</phone>
        <email>martina.lojova@mou.cz</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>University Hospital</name>
        <address>
          <city>Olomouc</city>
          <zip>77900</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Petr Jakubec, MD, PhD.</last_name>
        <phone>+420588445918</phone>
        <email>petr.jakubec@fnol.cz</email>
      </contact>
      <contact_backup>
        <last_name>Miroslav Herman, prof.MD PhD.</last_name>
        <phone>+420588443495</phone>
        <email>miroslav.herman@fnol.cz</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>General University Hospital in Prague</name>
        <address>
          <city>Praha</city>
          <zip>12808</zip>
          <country>Czechia</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Jiri Votruba, MD, Ph.D.</last_name>
        <phone>+420 224 969 355</phone>
        <email>jiri.votruba@vfn.cz</email>
      </contact>
      <contact_backup>
        <last_name>Lenka Navratova, MD</last_name>
        <phone>+420224969352</phone>
        <email>lenka.navratova@vfn.cz</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Czechia</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 29, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 29, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Lung Cancer</keyword>
    <keyword>Breath Condensate</keyword>
    <keyword>Biomarker</keyword>
    <keyword>Screening</keyword>
    <keyword>Early Cancer Detection</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06016569
  org study id: 60096
  nct id: NCT06016569
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Screening
  masking: None (Open Label)
  measure: Validation of the multiplex protein signature in exhaled air
  time frame: 5 years
  description: Validation of the multiplex protein signature in exhaled breath condensate based on the comparison with the LDCT.
  measure: Validation of the multiplex protein signature in exhaled breath for differential diagnostics of lung nodules
  time frame: 5 years
  description: Validation of the multiplex protein signature in exhaled breath for differential diagnostics of lung nodules
  measure: Assessment of the effectiveness of the screening program
  time frame: 5 years
  description: 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.
  measure: Total time of diagnosis of the nodule
  time frame: 5 years
  description: The total time of diagnosis of a solitary pulmonary nodule in positively screened patients for whom only observation is not a sufficient procedure.
  measure: Comparison of costs of screening procedures
  time frame: 5 years
  description: 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.
  measure: Assessment of success of the anti-smoking intervention
  time frame: 5 years
  description: Percentage success of the anti-smoking intervention in the examined probands.
  measure: Number of newly captured interstitial lung processes
  time frame: 5 years
  description: The number of newly captured interstitial lung processes will also be evaluated.
  arm group label: LDCT and collection of breath condensate and blood sample
  arm group type: Experimental
  description: 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.
  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
  criteria: 
  gender: All
  minimum age: 55 Years
  maximum age: 74 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Marian Hajduch, MD, PhD.
  role: Study Director
  affiliation: IMTM, Palacky University in Olomouc, Faculty of Medicine and Dentistry
  last name: Marian Hajduch, MD, PhD.
  phone: +420585632083
  email: marian.hajduch@upol.cz
  last name: Michaela Bendova, MSc.
  phone: +420585632050
  email: michaela.bendova@upol.cz
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  facility: 
  status: Not yet recruiting
  contact: 
  contact backup: 
  facility: 
  status: Not yet recruiting
  contact: 
  contact backup: 
  country: Czechia
  responsible party type: Sponsor
  mesh term: Lung Neoplasms
  sharing ipd: No