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/NCT05982899</url>
    </required_header>
    <id_info>
      <org_study_id>2020-273</org_study_id>
      <nct_id>NCT05982899</nct_id>
    </id_info>
    <brief_title>A Web-based Calculator Predicts Heterogeneous Frailty Trajectories</brief_title>
    <official_title>A Web-based Calculator Predicts Heterogeneous Frailty Trajectories Among Elderly Gastric Cancer Survivors</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Nanjing Medical University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Nanjing Medical University</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>
        To explore the predictive factors of frailty trajectories and develop a web-based nomogram&#xD;
        among gastric cancer survivors.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The aims of this study are to explore the predictive factors of frailty trajectories in&#xD;
        gastric cancer patients more comprehensively based on the health ecology theory and to&#xD;
        construct a clinically convenient web-based prediction calculator, so as to screen high-risk&#xD;
        frailty elderly gastric cancer patients at an early stage in clinical practice, and thus to&#xD;
        implement early interventions to improve the prognosis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">March 1, 2021</start_date>
    <completion_date type="Actual">April 1, 2023</completion_date>
    <primary_completion_date type="Actual">October 1, 2022</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>frailty trajectories</measure>
      <time_frame>1 year</time_frame>
      <description>Frailty was measured by Tilburg frailty indicator (TFI) scale at discharge, one month, three months, six months and twelve months after surgery.</description>
    </primary_outcome>
    <enrollment type="Actual">412</enrollment>
    <condition>Gastric Cancer</condition>
    <eligibility>
      <study_pop>
        <textblock>
          elderly gastric cancer survivors&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  diagnosed with gastric cancer by endoscopy or pathology;&#xD;
  &#xD;
            -  age ≥60 years old;&#xD;
  &#xD;
            -  radical gastrectomy was proposed;&#xD;
  &#xD;
            -  be able to communicate simply in writing and verbally.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  combined with other sites of malignant tumors;&#xD;
  &#xD;
            -  combined with severe heart, liver, lung, and renal insufficiency;&#xD;
  &#xD;
            -  recent using hormones, immunosuppressants;&#xD;
  &#xD;
            -  with physical disabilities.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <location>
      <facility>
        <name>Xueyi Miao</name>
        <address>
          <city>Nanjing</city>
          <state>Jiangsu</state>
          <zip>211166</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Nanjing medical university</name>
        <address>
          <city>Nanjing</city>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Nanjing Medical University</investigator_affiliation>
      <investigator_full_name>Xueyi Miao</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>gastric cancer</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stomach Neoplasms</mesh_term>
      <mesh_term>Frailty</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/NCT05982899
  org study id: 2020-273
  nct id: NCT05982899
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To explore the predictive factors of frailty trajectories and develop a web-based nomogram
        among gastric cancer survivors.
  The aims of this study are to explore the predictive factors of frailty trajectories in
        gastric cancer patients more comprehensively based on the health ecology theory and to
        construct a clinically convenient web-based prediction calculator, so as to screen high-risk
        frailty elderly gastric cancer patients at an early stage in clinical practice, and thus to
        implement early interventions to improve the prognosis.
  observational model: Cohort
  time perspective: Prospective
  measure: frailty trajectories
  time frame: 1 year
  description: Frailty was measured by Tilburg frailty indicator (TFI) scale at discharge, one month, three months, six months and twelve months after surgery.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  facility: 
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Nanjing Medical University
  investigator full name: Xueyi Miao
  investigator title: Principal Investigator
  mesh term: Stomach Neoplasms
  mesh term: Frailty