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/NCT06025045</url>
    </required_header>
    <id_info>
      <org_study_id>SunYatsen202309</org_study_id>
      <nct_id>NCT06025045</nct_id>
    </id_info>
    <brief_title>Dynamic Monitoring of ctDNA Predicts Recurrence of Advanced Ovarian Cancer After Primary Treatments</brief_title>
    <official_title>Dynamic Monitoring of ctDNA Predicts Recurrence of Advanced Ovarian Cancer After Primary Treatments</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Jing Li</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Nanjing Shihejiyin Technology, Inc.</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen 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>
        Patients who receive satisfactory PDS, currently the change in CA125 during chemotherapy can&#xD;
        only be used to evaluate the effectiveness of chemotherapy. This study plans to use ctDNA&#xD;
        dynamic monitoring to detect minimal residual lesions during treatment, to demonstrate the&#xD;
        application value of ctDNA dynamic monitoring in predicting the recurrence of ovarian cancer&#xD;
        after PDS/IDS surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study plans to include ovarian cancer patients who have undergone PDS/IDS surgery. By&#xD;
        analyzing the surgical tissue samples of ovarian cancer patients, we aim to identify risk&#xD;
        factors related to the prognosis and recurrence of ovarian cancer. By monitoring the ctDNA&#xD;
        status after PDS surgery, we analyze the role of ctDNA-MRD in predicting postoperative&#xD;
        recurrence of ovarian cancer. By monitoring the MRD status at the end of the 3rd cycle of&#xD;
        adjuvant chemotherapy and at the end of adjuvant treatment, we analyze the predictive role of&#xD;
        serial cDNA-MRD for the efficacy of adjuvant treatment, providing a basis for determining the&#xD;
        number of cycles of adjuvant treatment after PDS.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2022</start_date>
    <completion_date type="Anticipated">August 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2025</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>2 years DFS rate</measure>
      <time_frame>2 years</time_frame>
      <description>The recurrence rate of patients at two years after surgery</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>DFS</measure>
      <time_frame>2 years</time_frame>
      <description>Disease-free survival</description>
    </secondary_outcome>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Ovarian Cancer Stage IV</condition>
    <condition>Ovarian Cancer Stage III</condition>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Plasma sample； tumor tissue; WBC&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Advanced ovarian cancer patients&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. ≥ 18 years old.&#xD;
  &#xD;
            2. Patients diagnosed with stage IIIC-IVA ovarian cancer through pathological&#xD;
               examination.&#xD;
  &#xD;
            3. The participant has read and fully understands the patient information, and has signed&#xD;
               the informed consent form.&#xD;
  &#xD;
            4. The patient is willing to undergo primary debulking surgery (PDS) or interval&#xD;
               debulking surgery（IDS）. -&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Other tumors have been detected within the last 5 years.&#xD;
  &#xD;
            2. Organ transplant recipients or those who previously had non-autologous (allogeneic)&#xD;
               bone marrow or stem cell transplants.&#xD;
  &#xD;
            3. Patients was deemed unsuitable to participate in this study by other researchers.&#xD;
  &#xD;
            4. Patients who have previously received neoadjuvant chemotherapy or targeted therapy.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Jing Li, Prefessor</last_name>
      <phone>15915893493</phone>
      <email>lijing228@mail.sysu.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>Sun Yat-Sen Memorial Hospital</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jing Li, Professor</last_name>
        <phone>15915893493</phone>
        <email>lijing228@mail.sysu.edu.cn</email>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University</investigator_affiliation>
      <investigator_full_name>Jing Li</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>ctDNA</keyword>
    <keyword>Ovarian cancer</keyword>
    <keyword>PDS</keyword>
    <keyword>IDS</keyword>
    <keyword>adjuvant chemotherapy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ovarian Neoplasms</mesh_term>
      <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
      <mesh_term>Recurrence</mesh_term>
    </condition_browse>
    <!-- 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/NCT06025045
  org study id: SunYatsen202309
  nct id: NCT06025045
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Patients who receive satisfactory PDS, currently the change in CA125 during chemotherapy can
        only be used to evaluate the effectiveness of chemotherapy. This study plans to use ctDNA
        dynamic monitoring to detect minimal residual lesions during treatment, to demonstrate the
        application value of ctDNA dynamic monitoring in predicting the recurrence of ovarian cancer
        after PDS/IDS surgery.
  This study plans to include ovarian cancer patients who have undergone PDS/IDS surgery. By
        analyzing the surgical tissue samples of ovarian cancer patients, we aim to identify risk
        factors related to the prognosis and recurrence of ovarian cancer. By monitoring the ctDNA
        status after PDS surgery, we analyze the role of ctDNA-MRD in predicting postoperative
        recurrence of ovarian cancer. By monitoring the MRD status at the end of the 3rd cycle of
        adjuvant chemotherapy and at the end of adjuvant treatment, we analyze the predictive role of
        serial cDNA-MRD for the efficacy of adjuvant treatment, providing a basis for determining the
        number of cycles of adjuvant treatment after PDS.
  observational model: Case-Only
  time perspective: Retrospective
  measure: 2 years DFS rate
  time frame: 2 years
  description: The recurrence rate of patients at two years after surgery
  measure: DFS
  time frame: 2 years
  description: Disease-free survival
  Plasma sample； tumor tissue; WBC
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jing Li, Prefessor
  phone: 15915893493
  email: lijing228@mail.sysu.edu.cn
  facility: 
  status: Recruiting
  contact: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
  investigator full name: Jing Li
  investigator title: Professor
  mesh term: Ovarian Neoplasms
  mesh term: Carcinoma, Ovarian Epithelial
  mesh term: Recurrence