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/NCT05985941</url>
    </required_header>
    <id_info>
      <org_study_id>LY2023-110-A</org_study_id>
      <nct_id>NCT05985941</nct_id>
    </id_info>
    <brief_title>Prospective Multi-omics Observational Study of Gynecological Rare Pathological Tumors</brief_title>
    <official_title>Prospective Multi-omics Observational Study of Gynecological Rare Pathological Tumors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>RenJi Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>RenJi Hospital</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>
        The goal of this observational study is to draw the characteristic maps of genomics,&#xD;
        transcriptome, proteomics, metabolomics, etc. in 600 patients with gynecological rare&#xD;
        pathological types of malignant tumors. Then it is planned to explore the molecular mechanism&#xD;
        and find some new targets for diagnosis and treatment, and design and establish the database&#xD;
        system of the above rare tumors.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">May 2028</completion_date>
    <primary_completion_date type="Anticipated">May 2028</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>Multi-omics feature map</measure>
      <time_frame>August 2023 to May 2028</time_frame>
      <description>Draw the characteristic maps of imaging omics, genomics, transcriptome, proteomics, pathological omics, metabolomics, etc. of patients with gynecological rare pathological types of malignant tumors, and explore the molecular mechanism thus finding some new targets for diagnosis and treatment.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Database system</measure>
      <time_frame>August 2023 to May 2028</time_frame>
      <description>Design and establish the database system of the above gynecological rare pathological types of tumors.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Correlation analysis</measure>
      <time_frame>August 2023 to May 2028</time_frame>
      <description>Integrate the characteristic maps of imaging omics, genomics, transcriptome, proteomics, pathological omics, metabonomics, etc. to study their possible relevance.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">600</enrollment>
    <condition>Rare Gynecological Tumors</condition>
    <condition>Multi-omics Analysis</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with rare gynecological tumors who underwent surgery in three hospitals, including&#xD;
          Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine, Sun Yat-sen&#xD;
          Memorial Hospital affiliated to Sun Yat-sen University and the First Affiliated Hospital of&#xD;
          University of Science and Technology of China, were diagnosed as clear cell carcinoma&#xD;
          (ovary, uterus), neural small-cell carcinoma (ovary, uterus), carcinosarcoma or sarcoma&#xD;
          (ovary, uterus), cervical gastric adenocarcinoma, ovarian germ cell tumor, ovarian sex cord&#xD;
          stromal tumors, trophoblastic tumors, or perivascular epithelioid cell tumors (PECOMA),&#xD;
          among others.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1)Pathological diagnosis: clear cell carcinoma (ovary, uterus), nerve small-cell&#xD;
               carcinoma (ovary, uterus), carcinosarcoma or sarcoma (ovary, uterus), cervical gastric&#xD;
               adenocarcinoma, ovarian germ cell tumor, ovarian sex cord stromal tumor, trophoblastic&#xD;
               tumor, perivascular epithelioid cell tumor (PECOMA) and other rare gynecological&#xD;
               tumors; 2)Received pathological results from tumor surgery; 3)The patient voluntarily&#xD;
               participated in this research project with good compliance and was able to complete&#xD;
               the enrollment according to the experimental requirements; 4)Sign the informed consent&#xD;
               form and consent to the collection and use of their data, and consent to genomics,&#xD;
               transcriptome and other tests.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1)Patients with malignant tumors in other parts of the body; 2)Suffering from&#xD;
               uncontrollable neurological diseases, psychiatric diseases, or psychiatric disorders;&#xD;
               3)Poor compliance and inability to cooperate and describe treatment responders.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Genomics</keyword>
    <keyword>Transcriptome</keyword>
    <keyword>proteomics</keyword>
    <keyword>metabonomics</keyword>
    <keyword>Pathological omics</keyword>
    <keyword>Imaging omics</keyword>
    <!-- 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/NCT05985941
  org study id: LY2023-110-A
  nct id: NCT05985941
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to draw the characteristic maps of genomics,
        transcriptome, proteomics, metabolomics, etc. in 600 patients with gynecological rare
        pathological types of malignant tumors. Then it is planned to explore the molecular mechanism
        and find some new targets for diagnosis and treatment, and design and establish the database
        system of the above rare tumors.
  observational model: Cohort
  time perspective: Prospective
  measure: Multi-omics feature map
  time frame: August 2023 to May 2028
  description: Draw the characteristic maps of imaging omics, genomics, transcriptome, proteomics, pathological omics, metabolomics, etc. of patients with gynecological rare pathological types of malignant tumors, and explore the molecular mechanism thus finding some new targets for diagnosis and treatment.
  measure: Database system
  time frame: August 2023 to May 2028
  description: Design and establish the database system of the above gynecological rare pathological types of tumors.
  measure: Correlation analysis
  time frame: August 2023 to May 2028
  description: Integrate the characteristic maps of imaging omics, genomics, transcriptome, proteomics, pathological omics, metabonomics, etc. to study their possible relevance.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Sponsor