<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/NCT04462185</url>
  </required_header>
  <id_info>
    <org_study_id>AnchorDx LC023</org_study_id>
    <nct_id>NCT04462185</nct_id>
  </id_info>
  <brief_title>A Prospective Cohort Study of Chinese Patients With Pulmonary Nodules: Prediction of Lung Cancer Using Noninvasive Biomarkers</brief_title>
  <official_title>A Prospective Cohort Study of Chinese Patients With Pulmonary Nodules: Prediction of Lung Cancer Using Noninvasive Biomarkers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AnchorDx Medical Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The First Affiliated Hospital of Guangzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tongji Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Qilu Hospital of Shandong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>West China Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Beijing Chao Yang Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Johnson &amp; Johnson (China) Investment Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>AnchorDx Medical Co., Ltd.</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>
      The broad goals of this study is to identify changes in genomic landscape during transition&#xD;
      from stage 0 to stage 1 lung cancer.&#xD;
&#xD;
      This study intends to determine whether diagnostic biomarkers measured in minimally invasive&#xD;
      biospecimens are able to correlate molecular, clinical and imaging features to distinguish&#xD;
      malignant from benign pulmonary nodules. The diagnostic markers once validated can be used as&#xD;
      broad screening tools for lung cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The four-year study aims to recruit 3000 patients (1500 GGO and 1500 solid / semi solid&#xD;
      nodules) in the study based on qualifying for a lung cancer screening CT or by routine CT&#xD;
      chest with the observation of a lung nodule between 5-30mm diameter. These patients will be&#xD;
      followed for 2~3 years and be managed according to institutional standard of care. This may&#xD;
      involve the Chinese Thoracic Society guideline or Fleischner criteria (either 2013 or 2017&#xD;
      guidelines). The clinical data, CT imaging and biospecimens will be collected during each&#xD;
      visit. Once a patient undergoes surgery, tissue samples (FFPE) from surgery will also be&#xD;
      collected.&#xD;
&#xD;
      The gold standard for lung cancer diagnosis will be the results of bronchoscopic biopsy of&#xD;
      lung or lymph nodes, percutaneous biopsy of lung or other organ sites, surgical biopsy or&#xD;
      resection, or a minimum follow-up of 2 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">June 2024</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>The changes in genomic landscape related to progression from Stage 0 to Stage I lung cancer that could be utilized for early lung cancer diagnosis and intervention.</measure>
    <time_frame>3 Years</time_frame>
    <description>The transcriptome of benign versus malignant by using RNA sequencing. The cfDNA in blood samples collected from patients with pulmonary nodules.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The biomarker changes in nasal epithelium and matching blood and tissue samples so as to validate molecular tests using nasal epithelium to predict lung cancer.</measure>
    <time_frame>3 Years</time_frame>
    <description>The biomarker change in nasal epithelium to predict lung cancer.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The individual or combinations of clinical, molecular, and imaging features can reliably identify individuals with indeterminate lung nodules 5-30 mm who have lung cancer</measure>
    <time_frame>3 Years</time_frame>
    <description>The individual or combination of clinical, molecular, and imaging features can reliably identify individuals who have lung cancer</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Pulmonary Nodules</condition>
  <arm_group>
    <arm_group_label>Prospective Cohort</arm_group_label>
    <description>This is a prospectively enrolling cohort study and 3000 patients (1500 GGO and 1500 solid / semi solid nodules) with radiologic diagnosis of indeterminate pulmonary nodule (5-30 mm) will be recruited. All participants will be followed up with chest CT or low-dose computed tomography (LDCT) scans for 2-3 years, and take the diagnostic test, a genomic and transcriptomic landscape analysis, at each visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>A genomic and transcriptomic landscape analysis</intervention_name>
    <description>A genomic and transcriptomic landscape analysis will be developed to identify and characterize the transcriptome of benign versus malignant by using RNA sequencing, and to profile cfDNA in blood samples collected from patients with pulmonary nodules.</description>
    <arm_group_label>Prospective Cohort</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood; Nasal epithelium; Biopsy / surgical specimen&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with pulmonary nodules diagnosed by chest CT or low-dose computed tomography&#xD;
        (LDCT) scans between 5-30 mm diameter&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 Years and older, both male and female&#xD;
&#xD;
          -  Willing and able to provide a written informed consent&#xD;
&#xD;
          -  Radiologic diagnosis of solid indeterminate pulmonary nodule (5-30 mm) OR semi-solid&#xD;
             (mixed density) nodule with solid component of at least 5mm OR non-solid nodule&#xD;
             (including pGGO); must be of appropriate size at enrollment, but nodule(s) may have&#xD;
             been first identified within 12 months prior. Furthermore, nodule(s) &lt; 5 mm in size&#xD;
             may have been first identified greater than 12 months prior to enrollment though it&#xD;
             must grow into the appropriate size range (5-30 mm) within 12 months prior to&#xD;
             enrollment. If multiple nodules were diagnosed, choose the most representative one&#xD;
             with the longest diameter as the target lesion; if two or more nodules are of the same&#xD;
             largest size, choose the one with the perpendicular longest diameter&#xD;
&#xD;
          -  CT scan completed within 3 months prior to enrollment&#xD;
&#xD;
          -  Agree to tolerate all biospecimen collection as required by protocol&#xD;
&#xD;
          -  Agree to comply with standard of care follow up visits including clinical exams,&#xD;
             diagnostic work-ups, and imaging for 2~3 years from enrollment&#xD;
&#xD;
          -  Agree to fill out Patient Lung History Questionnaire&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History or previous diagnosis of primary lung cancer, metastatic lung cancer, or any&#xD;
             other non-lung cancer within 5 years (exceptions are adequately treated squamous and&#xD;
             basal cell carcinomas of the skin, carcinoma in situ of the cervix or breast)&#xD;
&#xD;
          -  Any receipt of cytotoxic agents within the past 6 months&#xD;
&#xD;
          -  Any symptoms of lung cancer (unexplained weight loss, recent hemoptysis)&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Underwent invasive biopsy procedures (e.g. bronchoscopies or CT-guided transthoracic&#xD;
             biopsies) before enrollment&#xD;
&#xD;
          -  Receipt of transfusion within 30 days prior to enrollment&#xD;
&#xD;
          -  Fail to understand or provide a written informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nanshan ZHONG, MD</last_name>
    <role>Study Chair</role>
    <affiliation>The First Affiliated Hospital of Guangzhou Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bo WANG</last_name>
    <phone>+86-15920405979</phone>
    <email>bo_wang@anchordx.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Wenhua LIANG, MD</last_name>
    <phone>+86-13710249454</phone>
    <email>liangwh1987@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Respiratory and Critical Care Medicine, Beijing Chaoyang Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Zhaohui TONG, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Department of Respiratory Medicine, West China Hospital of Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Dan LIU, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Guangzhou Medical University</name>
      <address>
        <city>Guangzhou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Wenhua LIANG, MD</last_name>
      <email>liangwh1987@163.com</email>
    </contact>
    <investigator>
      <last_name>Nanshan ZHONG, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Wenhua LIANG, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Department of Respiratory, Qilu Hospital, Shandong University</name>
      <address>
        <city>Jinan</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Wei XIAO, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Department of Pulmonary Medicine, Zhongshan Hospital, Fudan University</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Xin ZHANG, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Department of Respiratory and Critical Care Medicine, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology</name>
      <address>
        <city>Wuhan</city>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Jianping ZHAO, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>July 5, 2020</study_first_submitted>
  <study_first_submitted_qc>July 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>May 23, 2023</last_update_submitted>
  <last_update_submitted_qc>May 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Noninvasive Biomarkers</keyword>
  <keyword>Lung Cancer</keyword>
  <keyword>Computed Tomography (CT)</keyword>
  <keyword>Nasal epithelium</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Multiple Pulmonary Nodules</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/NCT04462185
org study id: AnchorDx LC023
nct id: NCT04462185
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The broad goals of this study is to identify changes in genomic landscape during transition
      from stage 0 to stage 1 lung cancer.

      This study intends to determine whether diagnostic biomarkers measured in minimally invasive
      biospecimens are able to correlate molecular, clinical and imaging features to distinguish
      malignant from benign pulmonary nodules. The diagnostic markers once validated can be used as
      broad screening tools for lung cancer.
The four-year study aims to recruit 3000 patients (1500 GGO and 1500 solid / semi solid
      nodules) in the study based on qualifying for a lung cancer screening CT or by routine CT
      chest with the observation of a lung nodule between 5-30mm diameter. These patients will be
      followed for 2~3 years and be managed according to institutional standard of care. This may
      involve the Chinese Thoracic Society guideline or Fleischner criteria (either 2013 or 2017
      guidelines). The clinical data, CT imaging and biospecimens will be collected during each
      visit. Once a patient undergoes surgery, tissue samples (FFPE) from surgery will also be
      collected.

      The gold standard for lung cancer diagnosis will be the results of bronchoscopic biopsy of
      lung or lymph nodes, percutaneous biopsy of lung or other organ sites, surgical biopsy or
      resection, or a minimum follow-up of 2 years.
observational model: Cohort
time perspective: Prospective
measure: The changes in genomic landscape related to progression from Stage 0 to Stage I lung cancer that could be utilized for early lung cancer diagnosis and intervention.
time frame: 3 Years
description: The transcriptome of benign versus malignant by using RNA sequencing. The cfDNA in blood samples collected from patients with pulmonary nodules.
measure: The biomarker changes in nasal epithelium and matching blood and tissue samples so as to validate molecular tests using nasal epithelium to predict lung cancer.
time frame: 3 Years
description: The biomarker change in nasal epithelium to predict lung cancer.
measure: The individual or combinations of clinical, molecular, and imaging features can reliably identify individuals with indeterminate lung nodules 5-30 mm who have lung cancer
time frame: 3 Years
description: The individual or combination of clinical, molecular, and imaging features can reliably identify individuals who have lung cancer
arm group label: Prospective Cohort
description: This is a prospectively enrolling cohort study and 3000 patients (1500 GGO and 1500 solid / semi solid nodules) with radiologic diagnosis of indeterminate pulmonary nodule (5-30 mm) will be recruited. All participants will be followed up with chest CT or low-dose computed tomography (LDCT) scans for 2-3 years, and take the diagnostic test, a genomic and transcriptomic landscape analysis, at each visit.
intervention type: Diagnostic Test
intervention name: A genomic and transcriptomic landscape analysis
description: A genomic and transcriptomic landscape analysis will be developed to identify and characterize the transcriptome of benign versus malignant by using RNA sequencing, and to profile cfDNA in blood samples collected from patients with pulmonary nodules.
arm group label: Prospective Cohort
Whole blood; Nasal epithelium; Biopsy / surgical specimen
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Nanshan ZHONG, MD
role: Study Chair
affiliation: The First Affiliated Hospital of Guangzhou Medical University
last name: Bo WANG
phone: +86-15920405979
email: bo_wang@anchordx.com
last name: Wenhua LIANG, MD
phone: +86-13710249454
email: liangwh1987@163.com
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Not yet recruiting
investigator: 
country: China
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Multiple Pulmonary Nodules
sharing ipd: No