<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/NCT03774758</url>
  </required_header>
  <id_info>
    <org_study_id>17-22915</org_study_id>
    <secondary_id>176517</secondary_id>
    <nct_id>NCT03774758</nct_id>
  </id_info>
  <brief_title>Biomarkers for Risk Stratification in Lung Cancer</brief_title>
  <official_title>Circulating Tumor DNA for Risk Stratification in Lung Cancer Screening</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Northern California Institute of Research and Education</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Guardant Health, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</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>
      This is a prospective observational study that will follow patients who undergo lung cancer&#xD;
      screening at the San Francisco VA Medical Center, University of California, San Francisco&#xD;
      (UCSF) Medical Center, and the San Francisco General Hospital. The proposed study will&#xD;
      comprise of two primary populations to determine the ctDNA assay performance in a variety of&#xD;
      clinical settings.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study objectives and statistical approaches to achieve those objectives are determined at the&#xD;
      level of the populations described below:&#xD;
&#xD;
      Population 1: Sensitivity and Specificity Thresholding.&#xD;
&#xD;
      In this phase, the technical feasibility of the intended use case will be assessed in the&#xD;
      intended use population relative to known cancer status as established by standard clinical&#xD;
      methods. ctDNA samples from enrolled patients will be assessed in each of the following&#xD;
      cohorts:&#xD;
&#xD;
      Cohort 1A: High-risk patients negative for lung cancer by CT screening and clinical&#xD;
      follow-up.&#xD;
&#xD;
      Cohort 1B: Patients with lung nodules ≥6 mm by CT but negative for lung cancer by extended (3&#xD;
      years) CT screening follow-up.&#xD;
&#xD;
      Cohort 1C: Patients with lung cancer (histologically proven or by consensus tumor board&#xD;
      opinion of ≥90% probability of cancer) prior to definitive therapy.&#xD;
&#xD;
      Population 2: Clinical Intended Use Performance. In this phase, the clinical performance of&#xD;
      the ctDNA assay will be evaluated in patients with high clinical suspicion for lung cancer.&#xD;
      ctDNA will be compared to the clinical diagnosis made according to the standard of care (e.g.&#xD;
      biopsy, CT surveillance, etc.). ctDNA samples from enrolled patients will be assessed in each&#xD;
      of the following cohorts:&#xD;
&#xD;
      Cohort 2A: High-risk patients newly positive (Lung imaging Reporting And Data System&#xD;
      (Lung-RADS) &gt;=3) by CT screening.&#xD;
&#xD;
      Cohort 2B: Patients with &gt;= 6 mm lung nodules suspicious for lung cancer by treating&#xD;
      physician judgment.&#xD;
&#xD;
      Cohort 2C: Patients with a personal history of lung cancer after completion of curative&#xD;
      intent treatment but without evidence of recurrence.&#xD;
&#xD;
      Specific Aim 1: To estimate the ctDNA assay sensitivity and specificity requirements in the&#xD;
      specific clinical use populations using patients with known non-small cell lung cancer&#xD;
      status.&#xD;
&#xD;
      Specific Aim 2: To prospectively estimate the ctDNA assay clinical performance in the&#xD;
      clinical application of interest.&#xD;
&#xD;
      ENDPOINTS&#xD;
&#xD;
      Primary Endpoints&#xD;
&#xD;
      Specific Aim 1: Estimation of the ctDNA assay's clinical sensitivity and specificity in&#xD;
      patients with lung cancer as proven by histology or tumor board consensus opinion* and in&#xD;
      patients with lung nodule ≥6 mm but without cancer as proven by extended CT screening&#xD;
      follow-up**.&#xD;
&#xD;
      *Patients may be treated with curative-intent Stereotactic Body Radiotherapy (SBRT) without&#xD;
      tissue confirmation IF pretest probability for lung cancer by tumor board consensus opinion&#xD;
      is ≥90% and the biopsy risk is high.&#xD;
&#xD;
      **Extended CT screening follow-up defined by documentation of ≥3 years of radiographic&#xD;
      stability and consensus clinical opinion.&#xD;
&#xD;
      Specific Aim 2: Estimation of the ctDNA assay's clinical predictive value relative to&#xD;
      standard of care diagnostic work-up in suspicious nodule adjudication in both the high-risk&#xD;
      and general populations (the clinical applications of interest).&#xD;
&#xD;
      Secondary Endpoints&#xD;
&#xD;
        -  Correlation of the ctDNA assay performance with Lung-RADS radiographic criteria&#xD;
&#xD;
        -  Correlation of Lung-RADS with disease truth defined by clinical follow up as the&#xD;
           definite gold standard&#xD;
&#xD;
      Exploratory Endpoints&#xD;
&#xD;
        -  Correlation of plasma and tissue genotyping results&#xD;
&#xD;
        -  Correlation of the ctDNA assay with orthogonal reference technologies (e.g. ddPCR)&#xD;
&#xD;
        -  Correlation of the ctDNA assay performance with histologic sub-type and clinical course&#xD;
           (e.g. aggressive vs. indolent disease)&#xD;
&#xD;
        -  Correlation of the ctDNA assay performance with clinical lung cancer risk factors&#xD;
&#xD;
        -  Correlation of the ctDNA assay results pre-and post-resection&#xD;
&#xD;
        -  Correlation of follow-up the ctDNA assay results and kinetics vs. clinical recurrence&#xD;
           post-resection or radiotherapy&#xD;
&#xD;
        -  Estimation of theoretical biopsy avoidance rate in clinical use population.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 17, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Sensitivity and specificity of ct-DNA LUNAR Assay</measure>
    <time_frame>Extended CT screening follow-up defined by documentation of ≥3 years of radiographic stability and/or consensus clinical opinion by tumor board.</time_frame>
    <description>Estimation of the ctDNA assay's clinical sensitivity and specificity in patients with lung cancer as proven by histology or tumor board consensus opinion* and in patients with lung nodule ≥6 mm but without cancer as proven by extended CT screening follow-up**.&#xD;
*Patients may be treated with curative-intent Stereotactic Body Radiotherapy (SBRT) without tissue confirmation IF pretest probability for lung cancer by tumor board consensus opinion is ≥90% and the biopsy risk is high.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Prospective negative predictive value of ct-DNA LUNAR assay</measure>
    <time_frame>Extended CT screening follow-up defined by documentation of ≥3 years of radiographic stability and/or consensus clinical opinion by tumor board.</time_frame>
    <description>Estimation of the ctDNA assay's clinical predictive value relative to standard of care diagnostic work-up in suspicious nodule adjudication in both the high-risk and general populations (the clinical applications of interest).</description>
  </primary_outcome>
  <number_of_groups>6</number_of_groups>
  <enrollment type="Anticipated">590</enrollment>
  <condition>Nodule Solitary Pulmonary</condition>
  <condition>Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Cohort 1A: Benign nodule on screening CT</arm_group_label>
    <description>High-risk patients eligible for lung cancer screening but with negative radiographic findings on CT screening (Lung RADS ≤2).&#xD;
≥30 pack-year history of cigarette smoking&#xD;
≥55 years of age&#xD;
Current smoker or quit within the past 15 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 1B: Incidental benign nodule</arm_group_label>
    <description>Patients with lung nodules ≥ 6 mm on routine (non-lung cancer screening) CT evaluation deemed suspicious for malignancy by initial physician judgment but not malignant by ≥2 years of radiographic stability and consensus clinical opinion.&#xD;
1- Age ≥40 years.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort IC: Presumed lung cancer</arm_group_label>
    <description>Patients with lung cancer (histologically proven or presumed by consensus opinion of tumor board); prior to definitive therapy.&#xD;
1- Age ≥40 years.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2A: Suspicious nodule</arm_group_label>
    <description>High-risk patients with newly diagnosed suspicious nodule of Lung RADS ≥3 on CT screening.&#xD;
≥30 pack-year history of cigarette smoking&#xD;
≥55 years of age&#xD;
Current smoker or quit within the past 15 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2B: Suspicious incidental nodule</arm_group_label>
    <description>Patients with newly diagnosed incidentally-found lung nodules ≥ 6 mm on routine CT evaluation deemed suspicious for malignancy by physician judgment.&#xD;
1- Age ≥40 years.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2C: Post-treatment lung cancer</arm_group_label>
    <description>Patients with previously treated lung cancer (histologically proven or by consensus opinion); status-post completion of definitive therapy (resection +/- chemotherapy or SBRT with curative intent) within the previous year with no current evidence of disease.&#xD;
1- Age ≥40 years.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Guardant Health ct-DNA LUNAR assay</intervention_name>
    <description>Guardant Health is focused on conquering cancer by using its breakthrough blood-based assays, vast data sets, and advanced analytics. In 2016, it announced Project LUNAR, an effort to apply Guardant Health's technology platform to early detection, recurrence monitoring, and assessing minimal residual disease.</description>
    <arm_group_label>Cohort 1A: Benign nodule on screening CT</arm_group_label>
    <arm_group_label>Cohort 1B: Incidental benign nodule</arm_group_label>
    <arm_group_label>Cohort 2A: Suspicious nodule</arm_group_label>
    <arm_group_label>Cohort 2B: Suspicious incidental nodule</arm_group_label>
    <arm_group_label>Cohort 2C: Post-treatment lung cancer</arm_group_label>
    <arm_group_label>Cohort IC: Presumed lung cancer</arm_group_label>
    <other_name>Liquid biopsy Using NGS to Assay high-Risk patients</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The goal of this study is to evaluate the ability of cell-free circulating tumor DNA (ctDNA)&#xD;
      using Guardant Health's LUNAR technology to detect early stage in lung cancer as compared to&#xD;
      healthy volunteers and those patients at high risk for lung cancer, but without a lung cancer&#xD;
      diagnosis. ctDNA arises when DNA fragments are released into the bloodstream after cell death&#xD;
      and is distinguished from non-cancerous cell-free DNA (cfDNA) by the presence of somatic&#xD;
      alterations, e.g. mutations, gene amplifications, and fusions. In advanced stage non-small&#xD;
      cell lung cancer (NSCLC), evaluation of ctDNA in plasma can be used detect the presence of&#xD;
      resistance mutations and ultimately guide treatment while obviating the need for tissue&#xD;
      biopsy.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        This is a prospective observational study that will follow patients who undergo lung cancer&#xD;
        screening at the San Francisco VA Medical Center, UCSF Medical Center, and the San&#xD;
        Francisco General Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 40 years&#xD;
&#xD;
          -  Ability to understand and provide written informed consent&#xD;
&#xD;
          -  Willingness to comply with study protocols and provide blood samples.&#xD;
&#xD;
          -  Willingness to complete 3-year clinical follow up&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active non-cutaneous malignancy within the past 5 years as per medical record or&#xD;
             patient report.&#xD;
&#xD;
          -  Exclusion criteria for possible follow-up visit blood draw:&#xD;
&#xD;
          -  Anemia - measured by hematocrit level of less than 30%, measured after the first blood&#xD;
             draw.&#xD;
&#xD;
          -  Malnourishment - determined by BMI less than 19. If subject has BMI greater or equal&#xD;
             to 19, but has a history of malnourishment, study staff will measure albumin level of&#xD;
             subject's blood after initial blood draw. Albumin level must be greater than 2.5 mg&#xD;
             per deciliter, or subject will be excluded.&#xD;
&#xD;
          -  Severe Chronic Obstructive Pulmonary Disease (COPD) - defined by Gold Stage IV.&#xD;
&#xD;
          -  Unstable heart conditions - defined by stable or unstable angina, recent myocardial&#xD;
             infarction (within the last 2 years), active congestive heart failure, ischemic&#xD;
             cardiomyopathy, or history of complications because of previous blood donation.&#xD;
&#xD;
          -  Liver cirrhosis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Mehrdad Arjomandi, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mehrdad Arjomandi, MD</last_name>
    <phone>877-827-3222</phone>
    <email>cancertrials@ucsf.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Zuckerberg San Francisco General Hospital and Trauma Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mehrdad Arjomandi, MD</last_name>
      <phone>877-827-3222</phone>
      <email>cancertrials@ucsf.edu</email>
    </contact>
    <investigator>
      <last_name>Mehrdad Arjomandi, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>San Francisco VA Medical Center</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94121</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mehrdad Arjomandi, M.D.</last_name>
      <phone>877-827-3222</phone>
      <email>cancertrials@ucsf.edu</email>
    </contact>
    <investigator>
      <last_name>Mehrdad Arjomandi, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94122</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mehrdad Arjomandi, MD</last_name>
      <phone>877-827-3222</phone>
      <email>cancertrials@ucsf.edu</email>
    </contact>
    <investigator>
      <last_name>Mehrdad Arjomandi, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>August 1, 2022</last_update_submitted>
  <last_update_submitted_qc>August 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Lung cancer screening</keyword>
  <keyword>Biomarkers of lung cancer</keyword>
  <keyword>Circulating tumor DNA</keyword>
  <keyword>Low dose computed tomography of lung</keyword>
  <keyword>Pulmonary nodule</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>


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/NCT03774758
org study id: 17-22915
secondary id: 176517
nct id: NCT03774758
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective observational study that will follow patients who undergo lung cancer
      screening at the San Francisco VA Medical Center, University of California, San Francisco
      (UCSF) Medical Center, and the San Francisco General Hospital. The proposed study will
      comprise of two primary populations to determine the ctDNA assay performance in a variety of
      clinical settings.
Study objectives and statistical approaches to achieve those objectives are determined at the
      level of the populations described below:

      Population 1: Sensitivity and Specificity Thresholding.

      In this phase, the technical feasibility of the intended use case will be assessed in the
      intended use population relative to known cancer status as established by standard clinical
      methods. ctDNA samples from enrolled patients will be assessed in each of the following
      cohorts:

      Cohort 1A: High-risk patients negative for lung cancer by CT screening and clinical
      follow-up.

      Cohort 1B: Patients with lung nodules ≥6 mm by CT but negative for lung cancer by extended (3
      years) CT screening follow-up.

      Cohort 1C: Patients with lung cancer (histologically proven or by consensus tumor board
      opinion of ≥90% probability of cancer) prior to definitive therapy.

      Population 2: Clinical Intended Use Performance. In this phase, the clinical performance of
      the ctDNA assay will be evaluated in patients with high clinical suspicion for lung cancer.
      ctDNA will be compared to the clinical diagnosis made according to the standard of care (e.g.
      biopsy, CT surveillance, etc.). ctDNA samples from enrolled patients will be assessed in each
      of the following cohorts:

      Cohort 2A: High-risk patients newly positive (Lung imaging Reporting And Data System
      (Lung-RADS) >=3) by CT screening.

      Cohort 2B: Patients with >= 6 mm lung nodules suspicious for lung cancer by treating
      physician judgment.

      Cohort 2C: Patients with a personal history of lung cancer after completion of curative
      intent treatment but without evidence of recurrence.

      Specific Aim 1: To estimate the ctDNA assay sensitivity and specificity requirements in the
      specific clinical use populations using patients with known non-small cell lung cancer
      status.

      Specific Aim 2: To prospectively estimate the ctDNA assay clinical performance in the
      clinical application of interest.

      ENDPOINTS

      Primary Endpoints

      Specific Aim 1: Estimation of the ctDNA assay's clinical sensitivity and specificity in
      patients with lung cancer as proven by histology or tumor board consensus opinion* and in
      patients with lung nodule ≥6 mm but without cancer as proven by extended CT screening
      follow-up**.

      *Patients may be treated with curative-intent Stereotactic Body Radiotherapy (SBRT) without
      tissue confirmation IF pretest probability for lung cancer by tumor board consensus opinion
      is ≥90% and the biopsy risk is high.

      **Extended CT screening follow-up defined by documentation of ≥3 years of radiographic
      stability and consensus clinical opinion.

      Specific Aim 2: Estimation of the ctDNA assay's clinical predictive value relative to
      standard of care diagnostic work-up in suspicious nodule adjudication in both the high-risk
      and general populations (the clinical applications of interest).

      Secondary Endpoints

        -  Correlation of the ctDNA assay performance with Lung-RADS radiographic criteria

        -  Correlation of Lung-RADS with disease truth defined by clinical follow up as the
           definite gold standard

      Exploratory Endpoints

        -  Correlation of plasma and tissue genotyping results

        -  Correlation of the ctDNA assay with orthogonal reference technologies (e.g. ddPCR)

        -  Correlation of the ctDNA assay performance with histologic sub-type and clinical course
           (e.g. aggressive vs. indolent disease)

        -  Correlation of the ctDNA assay performance with clinical lung cancer risk factors

        -  Correlation of the ctDNA assay results pre-and post-resection

        -  Correlation of follow-up the ctDNA assay results and kinetics vs. clinical recurrence
           post-resection or radiotherapy

        -  Estimation of theoretical biopsy avoidance rate in clinical use population.
observational model: Cohort
time perspective: Prospective
measure: Sensitivity and specificity of ct-DNA LUNAR Assay
time frame: Extended CT screening follow-up defined by documentation of ≥3 years of radiographic stability and/or consensus clinical opinion by tumor board.
description: Estimation of the ctDNA assay's clinical sensitivity and specificity in patients with lung cancer as proven by histology or tumor board consensus opinion* and in patients with lung nodule ≥6 mm but without cancer as proven by extended CT screening follow-up**.
*Patients may be treated with curative-intent Stereotactic Body Radiotherapy (SBRT) without tissue confirmation IF pretest probability for lung cancer by tumor board consensus opinion is ≥90% and the biopsy risk is high.
measure: Prospective negative predictive value of ct-DNA LUNAR assay
time frame: Extended CT screening follow-up defined by documentation of ≥3 years of radiographic stability and/or consensus clinical opinion by tumor board.
description: Estimation of the ctDNA assay's clinical predictive value relative to standard of care diagnostic work-up in suspicious nodule adjudication in both the high-risk and general populations (the clinical applications of interest).
arm group label: Cohort 1A: Benign nodule on screening CT
description: High-risk patients eligible for lung cancer screening but with negative radiographic findings on CT screening (Lung RADS ≤2).
≥30 pack-year history of cigarette smoking
≥55 years of age
Current smoker or quit within the past 15 years
arm group label: Cohort 1B: Incidental benign nodule
description: Patients with lung nodules ≥ 6 mm on routine (non-lung cancer screening) CT evaluation deemed suspicious for malignancy by initial physician judgment but not malignant by ≥2 years of radiographic stability and consensus clinical opinion.
1- Age ≥40 years.
arm group label: Cohort IC: Presumed lung cancer
description: Patients with lung cancer (histologically proven or presumed by consensus opinion of tumor board); prior to definitive therapy.
1- Age ≥40 years.
arm group label: Cohort 2A: Suspicious nodule
description: High-risk patients with newly diagnosed suspicious nodule of Lung RADS ≥3 on CT screening.
≥30 pack-year history of cigarette smoking
≥55 years of age
Current smoker or quit within the past 15 years
arm group label: Cohort 2B: Suspicious incidental nodule
description: Patients with newly diagnosed incidentally-found lung nodules ≥ 6 mm on routine CT evaluation deemed suspicious for malignancy by physician judgment.
1- Age ≥40 years.
arm group label: Cohort 2C: Post-treatment lung cancer
description: Patients with previously treated lung cancer (histologically proven or by consensus opinion); status-post completion of definitive therapy (resection +/- chemotherapy or SBRT with curative intent) within the previous year with no current evidence of disease.
1- Age ≥40 years.
intervention type: Diagnostic Test
intervention name: Guardant Health ct-DNA LUNAR assay
description: Guardant Health is focused on conquering cancer by using its breakthrough blood-based assays, vast data sets, and advanced analytics. In 2016, it announced Project LUNAR, an effort to apply Guardant Health's technology platform to early detection, recurrence monitoring, and assessing minimal residual disease.
arm group label: Cohort 1A: Benign nodule on screening CT
arm group label: Cohort 1B: Incidental benign nodule
arm group label: Cohort 2A: Suspicious nodule
arm group label: Cohort 2B: Suspicious incidental nodule
arm group label: Cohort 2C: Post-treatment lung cancer
arm group label: Cohort IC: Presumed lung cancer
other name: Liquid biopsy Using NGS to Assay high-Risk patients
The goal of this study is to evaluate the ability of cell-free circulating tumor DNA (ctDNA)
      using Guardant Health's LUNAR technology to detect early stage in lung cancer as compared to
      healthy volunteers and those patients at high risk for lung cancer, but without a lung cancer
      diagnosis. ctDNA arises when DNA fragments are released into the bloodstream after cell death
      and is distinguished from non-cancerous cell-free DNA (cfDNA) by the presence of somatic
      alterations, e.g. mutations, gene amplifications, and fusions. In advanced stage non-small
      cell lung cancer (NSCLC), evaluation of ctDNA in plasma can be used detect the presence of
      resistance mutations and ultimately guide treatment while obviating the need for tissue
      biopsy.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
last name: Mehrdad Arjomandi, M.D.
role: Principal Investigator
affiliation: University of California, San Francisco
last name: Mehrdad Arjomandi, MD
phone: 877-827-3222
email: cancertrials@ucsf.edu
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
sharing ipd: No