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/NCT06023121</url>
    </required_header>
    <id_info>
      <org_study_id>EOGC-biomarker</org_study_id>
      <nct_id>NCT06023121</nct_id>
    </id_info>
    <brief_title>Use of a Liquid Biopsy Signature to Detect Early-onset Gastric Cancer</brief_title>
    <official_title>Use of a Liquid Biopsy Signature as Blood Biomarker for Early Detection and Monitoring Early-onset Gastric Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Chinese PLA General Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Chinese PLA General Hospital</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Early-onset gastric cancer (EOGC) is a lethal malignancy with a poor prognosis. It differs&#xD;
        from late-onset gastric cancer (LOGC) in clinical and molecular characteristics. The current&#xD;
        strategies for EOGC detection have certain limitations in diagnostic performance due to the&#xD;
        rising trend in EOGC. Hence, identifying novel EOGC bioindicators is crucial.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Due to widespread gastric cancer (GC) detection efforts and timely interventions (removal of&#xD;
        precancerous lesions and early-stage GC), the GC-associated mortality rate has declined&#xD;
        worldwide. However, epidemiological studies show rising GC incidences among young adults (&lt;&#xD;
        50 years old) without familial or hereditary origin. This illness, known as early-onset GC&#xD;
        (EOGC), comprises 20-30% of new GC diagnoses, mainly among individuals aged 30-40 years; the&#xD;
        median overall survival time is 11.7 months. Although the underlying cause behind this trend&#xD;
        is poorly understood, there is a general understanding that EOGC epidemiologically,&#xD;
        biologically, and pathologically differs from late-onset GC (LOGC, ≥ 50 years). Therefore,&#xD;
        EOGC patients require clinical assessment and intervention distinct from those applied in&#xD;
        LOGC.&#xD;
  &#xD;
        Of note, several population-based epidemiological studies have suggested that EOGC patients&#xD;
        exhibit significantly different behaviors from LOGC patients. EOGC patients are more likely&#xD;
        to have earlier lymph node and distal metastasis than LOGC patients during disease&#xD;
        progression. These tough challenges raise clinical concerns: EOGC is more aggressive than&#xD;
        LOGC; thus, a delayed diagnosis can severely affect patient survival outcomes. Moreover, the&#xD;
        current approaches to GC detection, such as CEA, HP serology, and pepsinogen (PG), are&#xD;
        insufficient for detecting early-stage GC and have yet to be investigated in young&#xD;
        individuals with EOGC. Accordingly, these limitations strongly underscore the necessity to&#xD;
        establish potent alternative indicators that facilitate the timely detection of EOGC.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 1, 2018</start_date>
    <completion_date type="Actual">August 30, 2023</completion_date>
    <primary_completion_date type="Actual">August 1, 2023</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Detection of levels of an exosome-based liquid biopsy signature</measure>
      <time_frame>Through study completion, an average of 3 year</time_frame>
      <description>A three exo-LR (NALT1, PTENP1, and HOTTIP) liquid biopsy signature was developed for EOGC detection.</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">800</enrollment>
    <condition>Gastric Cancer</condition>
    <arm_group>
      <arm_group_label>Cases</arm_group_label>
      <description>Gastric cancer cases from two medical centers in China</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Controls</arm_group_label>
      <description>Controls from two medical centers in China</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Measurement of levels of an exosome-based liquid biopsy signature</intervention_name>
      <description>Each participant was enrolled to assess the levels of an exosome-based liquid biopsy signature</description>
      <arm_group_label>Cases</arm_group_label>
      <arm_group_label>Controls</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Blood sample&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Community Sample Shanxi - Hospital and community sample Beijing -Hospital&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Having signed informed consent&#xD;
  &#xD;
            -  50 years old ≥ Age ≥ 18 years old&#xD;
  &#xD;
            -  Histologically confirmed gastric adenocarcinoma&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Other previous malignancy within 5 year&#xD;
  &#xD;
            -  Surgery (excluding diagnostic biopsy) within 4 weeks prior to study&#xD;
  &#xD;
            -  Pregnancy or lactation period&#xD;
  &#xD;
            -  Legal incapacity&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Chinese PLA General Hospital Ethics Committee</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100853</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 5, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Chinese PLA General Hospital</investigator_affiliation>
      <investigator_full_name>Lin Chen</investigator_full_name>
      <investigator_title>Director of department of General Surgery</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stomach Neoplasms</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/NCT06023121
  org study id: EOGC-biomarker
  nct id: NCT06023121
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Early-onset gastric cancer (EOGC) is a lethal malignancy with a poor prognosis. It differs
        from late-onset gastric cancer (LOGC) in clinical and molecular characteristics. The current
        strategies for EOGC detection have certain limitations in diagnostic performance due to the
        rising trend in EOGC. Hence, identifying novel EOGC bioindicators is crucial.
  Due to widespread gastric cancer (GC) detection efforts and timely interventions (removal of
        precancerous lesions and early-stage GC), the GC-associated mortality rate has declined
        worldwide. However, epidemiological studies show rising GC incidences among young adults (<
        50 years old) without familial or hereditary origin. This illness, known as early-onset GC
        (EOGC), comprises 20-30% of new GC diagnoses, mainly among individuals aged 30-40 years; the
        median overall survival time is 11.7 months. Although the underlying cause behind this trend
        is poorly understood, there is a general understanding that EOGC epidemiologically,
        biologically, and pathologically differs from late-onset GC (LOGC, ≥ 50 years). Therefore,
        EOGC patients require clinical assessment and intervention distinct from those applied in
        LOGC.
  
        Of note, several population-based epidemiological studies have suggested that EOGC patients
        exhibit significantly different behaviors from LOGC patients. EOGC patients are more likely
        to have earlier lymph node and distal metastasis than LOGC patients during disease
        progression. These tough challenges raise clinical concerns: EOGC is more aggressive than
        LOGC; thus, a delayed diagnosis can severely affect patient survival outcomes. Moreover, the
        current approaches to GC detection, such as CEA, HP serology, and pepsinogen (PG), are
        insufficient for detecting early-stage GC and have yet to be investigated in young
        individuals with EOGC. Accordingly, these limitations strongly underscore the necessity to
        establish potent alternative indicators that facilitate the timely detection of EOGC.
  observational model: Cohort
  time perspective: Retrospective
  measure: Detection of levels of an exosome-based liquid biopsy signature
  time frame: Through study completion, an average of 3 year
  description: A three exo-LR (NALT1, PTENP1, and HOTTIP) liquid biopsy signature was developed for EOGC detection.
  arm group label: Cases
  description: Gastric cancer cases from two medical centers in China
  arm group label: Controls
  description: Controls from two medical centers in China
  intervention type: Diagnostic Test
  intervention name: Measurement of levels of an exosome-based liquid biopsy signature
  description: Each participant was enrolled to assess the levels of an exosome-based liquid biopsy signature
  arm group label: Cases
  arm group label: Controls
  Blood sample
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Chinese PLA General Hospital
  investigator full name: Lin Chen
  investigator title: Director of department of General Surgery
  mesh term: Stomach Neoplasms