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/NCT06007300</url>
    </required_header>
    <id_info>
      <org_study_id>LY-2023-136-B</org_study_id>
      <nct_id>NCT06007300</nct_id>
    </id_info>
    <brief_title>A Multiomics Study Based on the Dynamic Evolution of Endometrial Carcinogenesis</brief_title>
    <official_title>A Multiomics Study Based on the Dynamic Evolution of Endometrial Carcinogenesis</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>RenJi Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>RenJi Hospital</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 draw the characteristic maps of imaging omics,&#xD;
        genomics, transcriptome, proteomics, pathological omics, metabolomics, etc. of the dynamic&#xD;
        evolution of endometrial carcinogenesis in 100 patients with normal endometrium, 100 patients&#xD;
        with atypical endometrial hyperplasia, and 100 patients with endometrial cancer; and then to&#xD;
        explore the underlying molecular mechanism, and establish the database system for the dynamic&#xD;
        evolution of endometrial carcinogenesis.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">June 2026</completion_date>
    <primary_completion_date type="Anticipated">June 2026</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 mutant genes of participants and their expression as assessed by gene sequencing, RNA sequencing and mass spectrometry analysis</measure>
      <time_frame>August 2023 to June 2026</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Differences in the expression of these mutant genes among the three groups of participants as assessed by SAS® 9.4</measure>
      <time_frame>January 2026 to June 2026</time_frame>
    </primary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">300</enrollment>
    <condition>the Dynamic Evolution of Endometrial Carcinogenesis</condition>
    <condition>Multiomics Analysis</condition>
    <arm_group>
      <arm_group_label>Normal Group</arm_group_label>
      <description>Patients with normal endometrium</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Precancerous Group</arm_group_label>
      <description>Patients with atypical hyperplasia of endometrium</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Carcinoma Group</arm_group_label>
      <description>Patients with endometrial cancer</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with normal endometrium (requiring diagnostic or therapeutic hysteroscopy or&#xD;
          hysterectomy for other reasons), patients with precancerous lesions of endometrium, and&#xD;
          patients with endometrial cancer who underwent surgery in the gynecology and obstetrics&#xD;
          department of Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine,&#xD;
          whose illness was diagnosed as normal endometrium, atypical hyperplasia endometrium, or&#xD;
          endometrial cancer by pathology.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Pathological diagnosis: normal endometrium, atypical hyperplasia endometrium, or&#xD;
               endometrial cancer;&#xD;
  &#xD;
            -  Obtain pathological results after undergoing hysteroscopic surgery or hysterectomy;&#xD;
  &#xD;
            -  The patient voluntarily participated in this research project with good compliance and&#xD;
               was able to complete the enrollment according to the experimental requirements;&#xD;
  &#xD;
            -  Sign the informed consent form and consent to the collection and use of their data,&#xD;
               and consent to genomics, transcriptome and other tests.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with malignant tumors in other parts of the body;&#xD;
  &#xD;
            -  Suffering from uncontrollable neurological diseases, psychiatric diseases, or&#xD;
               psychiatric disorders;&#xD;
  &#xD;
            -  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 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Dynamic Evolution</keyword>
    <keyword>Genomics</keyword>
    <keyword>Transcriptome</keyword>
    <keyword>Proteomics</keyword>
    <keyword>Metabolomics</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinogenesis</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/NCT06007300
  org study id: LY-2023-136-B
  nct id: NCT06007300
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to draw the characteristic maps of imaging omics,
        genomics, transcriptome, proteomics, pathological omics, metabolomics, etc. of the dynamic
        evolution of endometrial carcinogenesis in 100 patients with normal endometrium, 100 patients
        with atypical endometrial hyperplasia, and 100 patients with endometrial cancer; and then to
        explore the underlying molecular mechanism, and establish the database system for the dynamic
        evolution of endometrial carcinogenesis.
  observational model: Cohort
  time perspective: Prospective
  measure: The mutant genes of participants and their expression as assessed by gene sequencing, RNA sequencing and mass spectrometry analysis
  time frame: August 2023 to June 2026
  measure: Differences in the expression of these mutant genes among the three groups of participants as assessed by SAS® 9.4
  time frame: January 2026 to June 2026
  arm group label: Normal Group
  description: Patients with normal endometrium
  arm group label: Precancerous Group
  description: Patients with atypical hyperplasia of endometrium
  arm group label: Carcinoma Group
  description: Patients with endometrial cancer
  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
  mesh term: Carcinogenesis