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/NCT06001099</url>
    </required_header>
    <id_info>
      <org_study_id>RSCD2021002</org_study_id>
      <nct_id>NCT06001099</nct_id>
    </id_info>
    <brief_title>PERformance of Multi-Cancer Early-detectIon Based on Various Biomarkers in fEmale Cancers, PERCEIVEII</brief_title>
    <official_title>Gynecological Malignancies Earlystage Detection by Multi-omics Based Liquid Biopsy in Peripheral Blood: a Prospective, Extended Validation Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fudan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Guangzhou Burning Rock Dx Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Fudan University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is a prospective study aimed to validate the performance of combined multi-omitcs&#xD;
        assays for early detection of gynecologic cancers. Biomarkers of cfDNA methylation, ctDNA&#xD;
        mutation and blood miRNA markers will be evaluated. The study will enroll approximately 2935&#xD;
        female participants, including participants with gynecologic cancers patients and healthy&#xD;
        participants.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 22, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</primary_completion_date>
    <study_type>Observational</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>
    <primary_outcome>
      <measure>To validate the sensitivity, specificity and accuracy of tissue traceability of an early detection model based on combined cfDNA methylation and serum tumor markers in patients with gynecological malignancies</measure>
      <time_frame>24 months</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>To verify the sensitivity, specificity and tissue traceability accuracy of cfDNA methylation as an early detection model for gynecological malignancies.</measure>
      <time_frame>24months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>To verify the sensitivity and specificity of serum tumor markers alone as an early detection model for gynecological malignant tumors</measure>
      <time_frame>24months</time_frame>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">2935</enrollment>
    <condition>Gynecologic Cancer</condition>
    <arm_group>
      <arm_group_label>Cancer arm</arm_group_label>
      <description>Participants with new diagnosis of gynecologic cancers, from whom blood samples will be collected</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Healthy arm</arm_group_label>
      <description>Participants without a known cancer or certain benign disease, from whom blood samples will be collected</description>
    </arm_group>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Plasma, white blood cells&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Eligible participants will be recruited from the participating medical center and assigned&#xD;
          into two arms, including participants with new diagnosis of gynecologic malignancies and&#xD;
          healthy controls&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria for Cancer Arm Participants:&#xD;
  &#xD;
            -  Age 18 years or older&#xD;
  &#xD;
            -  Able to provide a written informed consent&#xD;
  &#xD;
            -  Confirmed diagnosis or highly suspicious cases of gynecologic malignancies within 42&#xD;
               days prior to blood collection&#xD;
  &#xD;
            -  No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood&#xD;
               draw&#xD;
  &#xD;
          Exclusion Criteria for Cancer Arm Participants:&#xD;
  &#xD;
            -  Pregnancy or lactating women&#xD;
  &#xD;
            -  Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow&#xD;
               transplant or stem cell transplant&#xD;
  &#xD;
            -  Recipients of blood transfusion within 7 days prior to study blood draw&#xD;
  &#xD;
            -  Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to&#xD;
               diseases other than cancer.&#xD;
  &#xD;
            -  previous history of malignant tumor;&#xD;
  &#xD;
            -  precancerous lesions or benign diseases confirmed by biopsy or surgical specimen;&#xD;
  &#xD;
            -  unknown or insufficient to determine the nature of the lesion by histopathological&#xD;
               reports;&#xD;
  &#xD;
          Inclusion Criteria for healthy control Arm Participants:&#xD;
  &#xD;
            -  Able to provide a written informed consent.&#xD;
  &#xD;
            -  Able to provide sufficient and qualified blood samples for study tests.&#xD;
  &#xD;
            -  No cancer related symptoms within 30 days prior to study screening.&#xD;
  &#xD;
            -  Cancer history with curative treatment completed over 3 years without recurrence prior&#xD;
               to study enrollment.&#xD;
  &#xD;
          Exclusion Criteria for healthy control Arm Participants:&#xD;
  &#xD;
            -  Insufficient qualified blood sample for study test.&#xD;
  &#xD;
            -  During pregnancy or lactation.&#xD;
  &#xD;
            -  Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem&#xD;
               cell transplant.&#xD;
  &#xD;
            -  Recipient of blood transfusion within 30 days prior to study blood draw.&#xD;
  &#xD;
            -  Recipient of anti-infectious therapy within 14 days prior to study blood draw.&#xD;
  &#xD;
            -  Have received or are undergoing curative cancer treatment within three years prior to&#xD;
               study screening.&#xD;
  &#xD;
            -  With autoimmune or other diseases with severe comorbidities.&#xD;
        </textblock>
      </criteria>
      <gender>Female</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>Xiaohua Wu, MD.&amp;PHD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Department of Gynecological Oncology, Fudan University Shanghai Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hao Wen, MD.&amp;PHD</last_name>
      <phone>+86-021-64175590</phone>
      <phone_ext>81007</phone_ext>
      <email>wenhao_fdc@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yuzi Zhang, MD</last_name>
      <phone>+86-021-60293798</phone>
      <email>Z_Zhangyuzi@163.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Fudan university shanghai cancer center, Deparment of gynecologic oncology</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200032</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hao Wen, MD.&amp;PHD</last_name>
        <phone>+86-021-64175590</phone>
        <phone_ext>81007</phone_ext>
        <email>wenhao_fdc@163.com</email>
      </contact>
      <contact_backup>
        <last_name>Yuzi Zhang, M.D</last_name>
        <phone>+86-021-60293798</phone>
        <email>Z_Zhangyuzi@163.com</email>
      </contact_backup>
      <investigator>
        <last_name>Xiaohua Wu, MD.&amp;PHD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 14, 2023</last_update_submitted>
    <last_update_submitted_qc>August 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fudan University</investigator_affiliation>
      <investigator_full_name>Zhong Zheng MD</investigator_full_name>
      <investigator_title>Department of Gynecological Oncology, Fudan University Shanghai Cancer Center</investigator_title>
    </responsible_party>
    <keyword>gynecologic cancer</keyword>
    <keyword>early detection</keyword>
    <keyword>liquid biopsy</keyword>
    <keyword>cell-free DNA</keyword>
    <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/NCT06001099
  org study id: RSCD2021002
  nct id: NCT06001099
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This study is a prospective study aimed to validate the performance of combined multi-omitcs
        assays for early detection of gynecologic cancers. Biomarkers of cfDNA methylation, ctDNA
        mutation and blood miRNA markers will be evaluated. The study will enroll approximately 2935
        female participants, including participants with gynecologic cancers patients and healthy
        participants.
  observational model: Case-Control
  time perspective: Prospective
  measure: To validate the sensitivity, specificity and accuracy of tissue traceability of an early detection model based on combined cfDNA methylation and serum tumor markers in patients with gynecological malignancies
  time frame: 24 months
  measure: To verify the sensitivity, specificity and tissue traceability accuracy of cfDNA methylation as an early detection model for gynecological malignancies.
  time frame: 24months
  measure: To verify the sensitivity and specificity of serum tumor markers alone as an early detection model for gynecological malignant tumors
  time frame: 24months
  arm group label: Cancer arm
  description: Participants with new diagnosis of gynecologic cancers, from whom blood samples will be collected
  arm group label: Healthy arm
  description: Participants without a known cancer or certain benign disease, from whom blood samples will be collected
  Plasma, white blood cells
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Xiaohua Wu, MD.&PHD
  role: Principal Investigator
  affiliation: Department of Gynecological Oncology, Fudan University Shanghai Cancer Center
  last name: Hao Wen, MD.&PHD
  phone: +86-021-64175590
  phone ext: 81007
  email: wenhao_fdc@163.com
  last name: Yuzi Zhang, MD
  phone: +86-021-60293798
  email: Z_Zhangyuzi@163.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Fudan University
  investigator full name: Zhong Zheng MD
  investigator title: Department of Gynecological Oncology, Fudan University Shanghai Cancer Center
  sharing ipd: No