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/NCT05987189</url>
    </required_header>
    <id_info>
      <org_study_id>Boston II</org_study_id>
      <nct_id>NCT05987189</nct_id>
    </id_info>
    <brief_title>Diagnostic Performance of Small RNA Blood Test in Patients Undergoing Follow-up Imaging After Positive Low Dose CT Screening for Cancer of the Lung</brief_title>
    <official_title>Diagnostic Performance of Small RNA Blood Test in Patients Undergoing Follow-up Imaging After Positive Low Dose CT Screening for Cancer of the Lung &quot;Early Detection of Lung Cancer Based on Small RNA Signatures - Boston II&quot;</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hummingbird Diagnostics</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hummingbird Diagnostics</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>
        2,000 individuals, aged 50-80 who have received a lung-RADS category 3 or 4 result on a LDCT&#xD;
        screening study and who are scheduled for follow-up diagnostic imaging study, biopsy,&#xD;
        clinical consultation or surgical appointment at one of the participating hospitals.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study is a prospective, longitudinal, observational study to evaluate the performance of&#xD;
        a novel diagnostic test for early-stage lung cancer.&#xD;
  &#xD;
        Study duration: Expected patient enrollment to be completed within 12 months after study&#xD;
        initiation. Patients will be followed for a minimum of 12 months from the date of enrollment.&#xD;
        The study duration is approximately 2 years.&#xD;
  &#xD;
        Participant duration: The day of blood collection. Participants will follow their regular&#xD;
        standard of care schedule as recommended by existing guidelines; no extra visits are planned.&#xD;
        Follow up data will be obtained from the electronic medical record within at least 12 months&#xD;
        of follow-up period.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">October 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Primary Objective</measure>
      <time_frame>1 year</time_frame>
      <description>The study is a prospective, longitudinal, observational study to evaluate the performance of a novel diagnostic test for early-stage lung cancer. The primary endpoint is to detect the presence or absence of lung cancer, as determined by all follow-up imaging, and pathological data obtained throughout the duration of the study.</description>
    </primary_outcome>
    <enrollment type="Anticipated">2000</enrollment>
    <condition>Lung Cancer</condition>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>miLungDx</intervention_name>
      <description>At study enrollment a blood sample will be drawn prior to any invasive diagnostic study or treatment. On this blood sample a novel lung cancer test relying on small RNA signatures will be performed and evaluated.</description>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        *Blood sample (2x2,5 ml blood in PAXgene® tubes, 1x10 ml Streck® RNA Complete BCT CE blood,&#xD;
        1x10 ml Streck® Cell-free DNA BCT CE blood)&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Individuals, aged 50-80 who have received a lung-RADS category 3 or 4 result on a LDCT&#xD;
          screening study and who are scheduled for follow-up diagnostic imaging study, biopsy,&#xD;
          clinical consultation or surgical appointment at one of the participating hospitals.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult male and female patients, aged 50 to 80 years&#xD;
  &#xD;
            -  Received a lung RADS category 3 or 4 finding on a LDCT screening exam (first or&#xD;
               subsequent) and are referred to undergo further diagnostic procedures for the&#xD;
               detection of lung cancer&#xD;
  &#xD;
            -  Has undergone LD-CT screening exam within last 90 days and allows for blood sampling&#xD;
               within this period&#xD;
  &#xD;
            -  Subject may not have undergone any invasive diagnostic procedure in relation to the&#xD;
               suspicious nodule&#xD;
  &#xD;
            -  Able and willing to provide informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Prior history of diagnosed lung cancer&#xD;
  &#xD;
            -  History of gastrointestinal, hematological, breast, thyroid, and genitourinary cancer&#xD;
               within the past 10 years&#xD;
  &#xD;
            -  Active infectious diseases, such blood borne viral diseases (e.g. AIDS, hepatitis)&#xD;
  &#xD;
            -  Immunosuppressive medication&#xD;
  &#xD;
            -  Deemed not able to participate in the study by the investigator&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jose Ramirez, BS</last_name>
      <phone>06022910792</phone>
      <email>jose.ramirez@allucent.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>April 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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/NCT05987189
  org study id: Boston II
  nct id: NCT05987189
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  2,000 individuals, aged 50-80 who have received a lung-RADS category 3 or 4 result on a LDCT
        screening study and who are scheduled for follow-up diagnostic imaging study, biopsy,
        clinical consultation or surgical appointment at one of the participating hospitals.
  The study is a prospective, longitudinal, observational study to evaluate the performance of
        a novel diagnostic test for early-stage lung cancer.
  
        Study duration: Expected patient enrollment to be completed within 12 months after study
        initiation. Patients will be followed for a minimum of 12 months from the date of enrollment.
        The study duration is approximately 2 years.
  
        Participant duration: The day of blood collection. Participants will follow their regular
        standard of care schedule as recommended by existing guidelines; no extra visits are planned.
        Follow up data will be obtained from the electronic medical record within at least 12 months
        of follow-up period.
  observational model: Case-Only
  time perspective: Prospective
  measure: Primary Objective
  time frame: 1 year
  description: The study is a prospective, longitudinal, observational study to evaluate the performance of a novel diagnostic test for early-stage lung cancer. The primary endpoint is to detect the presence or absence of lung cancer, as determined by all follow-up imaging, and pathological data obtained throughout the duration of the study.
  intervention type: Diagnostic Test
  intervention name: miLungDx
  description: At study enrollment a blood sample will be drawn prior to any invasive diagnostic study or treatment. On this blood sample a novel lung cancer test relying on small RNA signatures will be performed and evaluated.
  *Blood sample (2x2,5 ml blood in PAXgene® tubes, 1x10 ml Streck® RNA Complete BCT CE blood,
        1x10 ml Streck® Cell-free DNA BCT CE blood)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 50 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Jose Ramirez, BS
  phone: 06022910792
  email: jose.ramirez@allucent.com
  responsible party type: Sponsor
  mesh term: Lung Neoplasms
  sharing ipd: No