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/NCT06016790</url>
    </required_header>
    <id_info>
      <org_study_id>ZE-OMIX-001</org_study_id>
      <nct_id>NCT06016790</nct_id>
    </id_info>
    <brief_title>Exploring a Breast Cancer Early Screening Model Based on cfDNA</brief_title>
    <official_title>Scientific Research on Exploring a Breast Cancer Early Screening Model Using cfDNA Multi-omics Liquid Biopsy Technology Based on Deep Learning</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>OmixScience Co., Ltd.</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Second Affiliated Hospital, School of Medicine, Zhejiang University</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 goal of this observational study is to use cfDNA multi-omics technology to explore a new&#xD;
        breast cancer early detection model to improve the accuracy of early diagnosis in breast&#xD;
        cancer patients. The main questions it aims to answer are:&#xD;
  &#xD;
          -  Evaluate the sensitivity and specificity of the early detection model for breast cancer&#xD;
             screening&#xD;
  &#xD;
          -  Evaluate participants' TeFei™ score Participants will be collected peripheral venous&#xD;
             blood before surgery or systemic treatment. The blood will then be sent to the&#xD;
             collaboration company for sequencing. The collaboration company will analyze the&#xD;
             sequencing results and build a cfDNA multi-omics signature library. Finally, the&#xD;
             collaboration company will use deep learning algorithms to train and optimize the&#xD;
             feature library.&#xD;
  &#xD;
        Researchers will compare the cancer group with a benign control group to determine the&#xD;
        model's effectiveness in differentiating between them.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 3, 2023</start_date>
    <completion_date type="Anticipated">May 2, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 2, 2024</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>3 Days</target_duration>
    <primary_outcome>
      <measure>Evaluate the sensitivity and specificity of the early detection model for breast cancer screening</measure>
      <time_frame>60 days</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Evaluate participants' TeFei™ score</measure>
      <time_frame>60 days</time_frame>
      <description>This test is based on the expression level of key genes in the cfDNA tumor of the participant's blood sample, and the relative expression level of these genes is calculated to obtain a score. This score is called the TeFei™ Score and usually ranges from 0 to 100, with a higher score indicating a higher tumor burden in the patient.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">480</enrollment>
    <condition>Breast Cancer</condition>
    <condition>Breast Fibroadenoma</condition>
    <condition>Breast Hypoplasia</condition>
    <arm_group>
      <arm_group_label>the cancer group</arm_group_label>
      <description>200 cases of early breast cancer (stage I-IIa breast cancer, and breast carcinoma in situ) and 80 cases of middle and advanced breast cancer (stage IIb, IIc, III, IV)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>the benign control group</arm_group_label>
      <description>200 cases of control group (100 cases of breast hyperplasia, 100 cases of breast fibroma)</description>
    </arm_group>
    <intervention>
      <intervention_type>Genetic</intervention_type>
      <intervention_name>cfDNA sequencing</intervention_name>
      <description>Multi-omics sequencing of cfDNA in peripheral venous blood.</description>
      <arm_group_label>the benign control group</arm_group_label>
      <arm_group_label>the cancer group</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        peripheral venous blood with cfDNA&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Breast cancer patients and patients with benign breast diseases.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients ≥18 years old and ≤70 years old;&#xD;
  &#xD;
            2. Plasma of the participant can be obtained;&#xD;
  &#xD;
            3. Willing to sign the informed consent;&#xD;
  &#xD;
            4. Meet one of the following criteria:&#xD;
  &#xD;
          4.1)Patients diagnosed with invasive breast cancer or carcinoma in situ of the breast for&#xD;
          the first time; 4.2)Patients with breast fibroma or breast adenosis and breast fibrocystic&#xD;
          hyperplasia;&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          In any of the following situations, subjects should not participate in the trial:&#xD;
  &#xD;
            1. Pregnant or lactating;&#xD;
  &#xD;
            2. Unable to obtain the participant's plasma;&#xD;
  &#xD;
            3. Patients with other types of malignant tumors diagnosed by pathology within 5 years&#xD;
               before enrollment;&#xD;
  &#xD;
            4. The patients had suspected imaging (B-ultrasound, CT, etc.) of other malignant tumors&#xD;
               within the past 1 year after enrollment, but no pathological confirmation;&#xD;
  &#xD;
            5. Received any blood product transfusion in the past 30 days;&#xD;
  &#xD;
            6. Participants considered by the investigator to be inappropriate to participate in this&#xD;
               research-type clinical trial.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Chao Ni</last_name>
      <role>Principal Investigator</role>
      <affiliation>Second Affiliated Hospital of Zhejiang University School of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Yanchang Li</last_name>
      <phone>086 18595444144</phone>
      <email>liyanchang@omixscience.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jialiang Fang</last_name>
      <phone>086 13575710428</phone>
      <email>fangjialiang@omixscience.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Second Affiliated Hospital of Zhejiang University School of Medicine</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310009</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Chao Ni</last_name>
        <phone>086 13989463951</phone>
        <email>nicaho428@zju.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <link>
      <url>http://www.freenome.com/largest-clinical-study-validating-a-blood-based-colorectal-screening-test-completes-enrollment</url>
      <description>Freenome, a privately held biotech company, announced the completion of enrollment for PREEMPT CRC, the company's large, prospective study to validate its blood test for colorectal cancer (CRC) screening among average-risk adults.</description>
    </link>
    <results_reference>
      <citation>Mathios D, Johansen JS, Cristiano S, Medina JE, Phallen J, Larsen KR, Bruhm DC, Niknafs N, Ferreira L, Adleff V, Chiao JY, Leal A, Noe M, White JR, Arun AS, Hruban C, Annapragada AV, Jensen SO, Orntoft MW, Madsen AH, Carvalho B, de Wit M, Carey J, Dracopoli NC, Maddala T, Fang KC, Hartman AR, Forde PM, Anagnostou V, Brahmer JR, Fijneman RJA, Nielsen HJ, Meijer GA, Andersen CL, Mellemgaard A, Bojesen SE, Scharpf RB, Velculescu VE. Detection and characterization of lung cancer using cell-free DNA fragmentomes. Nat Commun. 2021 Aug 20;12(1):5060. doi: 10.1038/s41467-021-24994-w.</citation>
      <PMID>34417454</PMID>
    </results_reference>
    <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 30, 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 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Second Affiliated Hospital, School of Medicine, Zhejiang University</investigator_affiliation>
      <investigator_full_name>Ni Chao</investigator_full_name>
      <investigator_title>Associate Chief Physician of Breast Surgery</investigator_title>
    </responsible_party>
    <keyword>cfDNA</keyword>
    <keyword>Deep learning</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Breast Neoplasms</mesh_term>
      <mesh_term>Fibroadenoma</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Because the database is related to the products of the cooperative company, in order to protect the intellectual property rights of the cooperative company, IPD will not be shared.</ipd_description>
    </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/NCT06016790
  org study id: ZE-OMIX-001
  nct id: NCT06016790
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to use cfDNA multi-omics technology to explore a new
        breast cancer early detection model to improve the accuracy of early diagnosis in breast
        cancer patients. The main questions it aims to answer are:
  
          -  Evaluate the sensitivity and specificity of the early detection model for breast cancer
             screening
  
          -  Evaluate participants' TeFei™ score Participants will be collected peripheral venous
             blood before surgery or systemic treatment. The blood will then be sent to the
             collaboration company for sequencing. The collaboration company will analyze the
             sequencing results and build a cfDNA multi-omics signature library. Finally, the
             collaboration company will use deep learning algorithms to train and optimize the
             feature library.
  
        Researchers will compare the cancer group with a benign control group to determine the
        model's effectiveness in differentiating between them.
  observational model: Case-Control
  time perspective: Prospective
  measure: Evaluate the sensitivity and specificity of the early detection model for breast cancer screening
  time frame: 60 days
  measure: Evaluate participants' TeFei™ score
  time frame: 60 days
  description: This test is based on the expression level of key genes in the cfDNA tumor of the participant's blood sample, and the relative expression level of these genes is calculated to obtain a score. This score is called the TeFei™ Score and usually ranges from 0 to 100, with a higher score indicating a higher tumor burden in the patient.
  arm group label: the cancer group
  description: 200 cases of early breast cancer (stage I-IIa breast cancer, and breast carcinoma in situ) and 80 cases of middle and advanced breast cancer (stage IIb, IIc, III, IV)
  arm group label: the benign control group
  description: 200 cases of control group (100 cases of breast hyperplasia, 100 cases of breast fibroma)
  intervention type: Genetic
  intervention name: cfDNA sequencing
  description: Multi-omics sequencing of cfDNA in peripheral venous blood.
  arm group label: the benign control group
  arm group label: the cancer group
  peripheral venous blood with cfDNA
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Chao Ni
  role: Principal Investigator
  affiliation: Second Affiliated Hospital of Zhejiang University School of Medicine
  last name: Yanchang Li
  phone: 086 18595444144
  email: liyanchang@omixscience.com
  last name: Jialiang Fang
  phone: 086 13575710428
  email: fangjialiang@omixscience.com
  facility: 
  status: Recruiting
  contact: 
  country: China
  url: http://www.freenome.com/largest-clinical-study-validating-a-blood-based-colorectal-screening-test-completes-enrollment
  description: Freenome, a privately held biotech company, announced the completion of enrollment for PREEMPT CRC, the company's large, prospective study to validate its blood test for colorectal cancer (CRC) screening among average-risk adults.
  citation: Mathios D, Johansen JS, Cristiano S, Medina JE, Phallen J, Larsen KR, Bruhm DC, Niknafs N, Ferreira L, Adleff V, Chiao JY, Leal A, Noe M, White JR, Arun AS, Hruban C, Annapragada AV, Jensen SO, Orntoft MW, Madsen AH, Carvalho B, de Wit M, Carey J, Dracopoli NC, Maddala T, Fang KC, Hartman AR, Forde PM, Anagnostou V, Brahmer JR, Fijneman RJA, Nielsen HJ, Meijer GA, Andersen CL, Mellemgaard A, Bojesen SE, Scharpf RB, Velculescu VE. Detection and characterization of lung cancer using cell-free DNA fragmentomes. Nat Commun. 2021 Aug 20;12(1):5060. doi: 10.1038/s41467-021-24994-w.
  PMID: 34417454
  responsible party type: Principal Investigator
  investigator affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
  investigator full name: Ni Chao
  investigator title: Associate Chief Physician of Breast Surgery
  mesh term: Breast Neoplasms
  mesh term: Fibroadenoma
  sharing ipd: No
  ipd description: Because the database is related to the products of the cooperative company, in order to protect the intellectual property rights of the cooperative company, IPD will not be shared.