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/NCT05976932</url>
    </required_header>
    <id_info>
      <org_study_id>2210263-1</org_study_id>
      <nct_id>NCT05976932</nct_id>
    </id_info>
    <brief_title>Circulating Tumor DNA Monitoring in Platinum-resistant Ovarian Cancer</brief_title>
    <official_title>The Utility of Circulating Tumor DNA in Monitoring the Response to Pegylated Liposomal Doxorubicin in Platinum-resistant Ovarian Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Fudan University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Fudan 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>
        This observational study is conducted to assess the utility of circulating tumor DNA in&#xD;
        monitoring the response to pegylated liposomal doxorubicin in platinum-resistant ovarian&#xD;
        cancer，and evaluate the consistency of circulating tumor DNA with imaging and CA125 in&#xD;
        platinum-resistant ovarian cancer.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The goal of this study is to assess the utility of circulating tumor DNA in monitoring the&#xD;
        response to pegylated liposomal doxorubicin in platinum-resistant ovarian cancer.This is a&#xD;
        single-arm, single-center prospective clinical study.&#xD;
  &#xD;
        After enrollment, patients will receive standard treatment (pegylated liposomal&#xD;
        doxorubicin)and follow-up strategy. Peripheral blood samples will be collected from all&#xD;
        patients before treatment and 3 weeks after the first cycle of treatment，If necessary,&#xD;
        Peripheral blood samples also be collected after 2 cycles of treatment.Peripheral blood ctDNA&#xD;
        will be tested for genetic variation based on next-generation sequencing (NGS).&#xD;
  &#xD;
        Finally, this study will to evaluate the consistency of circulating tumor DNA with imaging&#xD;
        and CA125 in platinum-resistant ovarian cancer.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">October 2024</completion_date>
    <primary_completion_date type="Anticipated">April 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 consistency of circulating tumor DNA with CT scan</measure>
      <time_frame>at the beginning of Cycle 1 and 3 weeks after Cycle 1. If necessary, also including 3 weeks after Cycle 2（each cycle is 28 days）</time_frame>
      <description>measuring the mutations of TP53，reporting the changes from baseline to 3 weeks after the first cycle, contrasting with CT scan changes，calculating Kappa value，and conducting a intrarater reliability</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Ovarian Cancer</condition>
    <arm_group>
      <arm_group_label>treatment group</arm_group_label>
      <description>After enrollment, patients will receive standard treatment (pegylated liposomal doxorubicin) and follow-up strategy. Peripheral blood samples will be collected from all patients before treatment and 3 weeks after the first cycle of treatment，If necessary, Peripheral blood samples also be collected after 2 cycles of treatment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>pegylated liposomal doxorubicin</intervention_name>
      <description>All eligible subjects will receive the standard chemotherapy of pegylated liposomal doxorubicin monotherapy.</description>
      <arm_group_label>treatment group</arm_group_label>
      <other_name>PLD</other_name>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        peripheral blood&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          platinum-resistant ovarian cancer&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Female, over 18 years of age;&#xD;
  &#xD;
            2. Patients with histopathological diagnosis of high-grade serous epithelial ovarian&#xD;
               cancer;&#xD;
  &#xD;
            3. pathological report:phenotype of p53 mutation；or previous genetic tests of tumor&#xD;
               tissue indicated TP53 gene mutations;&#xD;
  &#xD;
            4. ECOG≤ 2;&#xD;
  &#xD;
            5. Expected survival time ≥3 months;&#xD;
  &#xD;
            6. The subjects were able to understand the study process and voluntarily joined the&#xD;
               study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Pregnant and lactating patients;&#xD;
  &#xD;
            2. Patients with severe or uncontrolled infections;&#xD;
  &#xD;
            3. Patients who are allergic or intolerant to the investigational drug;&#xD;
  &#xD;
            4. Patients who are enrolled in or within a month of another clinical trial.&#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>Hao Wen, MD</last_name>
      <phone>+86-021-64175590 ext 81000</phone>
      <email>wenhao@shca.org.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Xiaohua Wu, MD</last_name>
      <phone>+86-021-64175590 ext 81000</phone>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Fudan University</investigator_affiliation>
      <investigator_full_name>Xiaohua Wu</investigator_full_name>
      <investigator_title>Director,Clinical Professor</investigator_title>
    </responsible_party>
    <keyword>ctDNA</keyword>
    <keyword>pegylated liposomal doxorubicin</keyword>
    <keyword>ovarian cancer</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>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Doxorubicin</mesh_term>
      <mesh_term>Liposomal doxorubicin</mesh_term>
    </intervention_browse>
    <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/NCT05976932
  org study id: 2210263-1
  nct id: NCT05976932
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This observational study is conducted to assess the utility of circulating tumor DNA in
        monitoring the response to pegylated liposomal doxorubicin in platinum-resistant ovarian
        cancer，and evaluate the consistency of circulating tumor DNA with imaging and CA125 in
        platinum-resistant ovarian cancer.
  The goal of this study is to assess the utility of circulating tumor DNA in monitoring the
        response to pegylated liposomal doxorubicin in platinum-resistant ovarian cancer.This is a
        single-arm, single-center prospective clinical study.
  
        After enrollment, patients will receive standard treatment (pegylated liposomal
        doxorubicin)and follow-up strategy. Peripheral blood samples will be collected from all
        patients before treatment and 3 weeks after the first cycle of treatment，If necessary,
        Peripheral blood samples also be collected after 2 cycles of treatment.Peripheral blood ctDNA
        will be tested for genetic variation based on next-generation sequencing (NGS).
  
        Finally, this study will to evaluate the consistency of circulating tumor DNA with imaging
        and CA125 in platinum-resistant ovarian cancer.
  observational model: Cohort
  time perspective: Prospective
  measure: the consistency of circulating tumor DNA with CT scan
  time frame: at the beginning of Cycle 1 and 3 weeks after Cycle 1. If necessary, also including 3 weeks after Cycle 2（each cycle is 28 days）
  description: measuring the mutations of TP53，reporting the changes from baseline to 3 weeks after the first cycle, contrasting with CT scan changes，calculating Kappa value，and conducting a intrarater reliability
  arm group label: treatment group
  description: After enrollment, patients will receive standard treatment (pegylated liposomal doxorubicin) and follow-up strategy. Peripheral blood samples will be collected from all patients before treatment and 3 weeks after the first cycle of treatment，If necessary, Peripheral blood samples also be collected after 2 cycles of treatment.
  intervention type: Drug
  intervention name: pegylated liposomal doxorubicin
  description: All eligible subjects will receive the standard chemotherapy of pegylated liposomal doxorubicin monotherapy.
  arm group label: treatment group
  other name: PLD
  peripheral blood
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Hao Wen, MD
  phone: +86-021-64175590 ext 81000
  email: wenhao@shca.org.cn
  last name: Xiaohua Wu, MD
  phone: +86-021-64175590 ext 81000
  responsible party type: Principal Investigator
  investigator affiliation: Fudan University
  investigator full name: Xiaohua Wu
  investigator title: Director,Clinical Professor
  mesh term: Ovarian Neoplasms
  mesh term: Carcinoma, Ovarian Epithelial
  mesh term: Doxorubicin
  mesh term: Liposomal doxorubicin
  sharing ipd: No