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/NCT05969444</url>
    </required_header>
    <id_info>
      <org_study_id>1230504 (AR)</org_study_id>
      <nct_id>NCT05969444</nct_id>
    </id_info>
    <brief_title>Endoscopic Surveillance on a High-risk Population for Gastric Cancer in Latin America: The ECHOS Cohort Study.</brief_title>
    <acronym>ECHOS</acronym>
    <official_title>The Impact of Endoscopic Surveillance of Atrophic Gastritis With and Without Intestinal Metaplasia on a High-risk Population for Gastric Cancer in Latin America: The ECHOS Cohort Study.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Pontificia Universidad Catolica de Chile</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Agencia Nacional de Investigación y Desarrollo</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>European Union</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Pontificia Universidad Catolica de Chile</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 evaluate the risk factors associated with incident&#xD;
        HGD/GA in patients with CAG with or without IM who are enrolled in endoscopic surveillance,&#xD;
        as well as to compare GA incidence according to the OLGA and OLGIM scales in patients 18&#xD;
        years or older.&#xD;
  &#xD;
        . The main questions it aims to answer are:&#xD;
  &#xD;
          -  What risk factors are associated with incident HGD/GA in patients with CAG with or&#xD;
             without IM?&#xD;
  &#xD;
          -  What is the comparative HGD/GA incidence according to the OLGA and OLGIM scales?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The Endoscopic Cohort and Histological OLGA staging (ECHOS) study is a retrospective&#xD;
        longitudinal cohort developed in the Pontificia Universidad Católica de Chile health care&#xD;
        system, an open health care system with 3 endoscopic units in Santiago, Chile. Patients 18&#xD;
        years or older were eligible for the study if they had at least one non-urgent outpatient EGD&#xD;
        with gastric biopsies collected following the USSBP between June 2015 and June 2021. The&#xD;
        baseline EGD was defined as the earliest examination conducted between this time frame that&#xD;
        met inclusion criteria. Participants were included in the cohort if they underwent a&#xD;
        subsequent &quot;surveillance&quot; EGD. In order for the subsequent EGD to qualify as surveillance, it&#xD;
        needed to occur at least 6 months after the baseline EGD and include gastric biopsies&#xD;
        collected according to the USSBP; one exception to the USSBP requirement was if HGD or GA was&#xD;
        detected on the surveillance (i.e. non-baseline) EGD. Patients with prior history of HGD or&#xD;
        any type of gastric malignancy, gastrectomy or non-gastric active malignancy were excluded.&#xD;
        Also, patients with HGD or GA on the baseline EGD were excluded. Patients with indefinite&#xD;
        (IND) or low-grade dysplasia (LGD) on the baseline EGD were considered for the cohort.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">June 1, 2015</start_date>
    <completion_date type="Actual">March 6, 2023</completion_date>
    <primary_completion_date type="Actual">June 30, 2021</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>High grade dysplasia/Gastric adenocarcinoma</measure>
      <time_frame>At least 6 months between first and second EGD, assessed up to 96 months</time_frame>
      <description>Progression from chronic atrophic gastritis or intestinal metaplasia according to baseline Operative Link on Gastritis Assessment (OLGA) staging in baseline measurement to high-grade dysplasia and adenocarcinoma.&#xD;
  The OLGA uses grades from in tiered scale from 0 to IV, resulting from the combination of atrophic changes (0 = absent; 1 = mild; 2 = moderate; 3 = severe) in the two mucosal compartments (antrum and corpus).</description>
    </primary_outcome>
    <enrollment type="Actual">685</enrollment>
    <condition>Gastric Cancer</condition>
    <condition>Dysplasia Stomach</condition>
    <condition>Atrophic Gastritis</condition>
    <condition>Helicobacter Pylori Infection</condition>
    <biospec_retention>None Retained</biospec_retention>
    <biospec_descr>
      <textblock>
        Gastric mucosa biopsies were obtained following the USSBP as follows:&#xD;
  &#xD;
          -  Two tissue samples obtained from the antrum (within 2 to 3 cm from the pylorus, from&#xD;
             lesser and greater curvature)&#xD;
  &#xD;
          -  One sample from the incisura angularis&#xD;
  &#xD;
          -  Two samples from the body (one from lesser curvature, ~4 cm proximal from the angle,e&#xD;
             and one from greater curvature, ~8 cm distal to cardia)&#xD;
  &#xD;
          -  Samples from each anatomical location were collected either directed to a suspicious&#xD;
             endoscopic finding of CAG or IM or following anatomical reference of the protocol if&#xD;
             apparently normal gastric mucosa was visualized&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Patients atteding an EGD at Pontificia Universidad Católica de Chile health care system, an&#xD;
          open health care system with three endoscopic units in Santiago, Chile.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  At least one non-urgent outpatient esophagogastroduodenoscopy (EGD) with gastric&#xD;
               biopsies collected following the Updated Sydney System Biopsy Protocol (USSBP) between&#xD;
               June 2015 and June 2021.&#xD;
  &#xD;
            -  Underwent a subsequent &quot;surveillance&quot; EGD. For the subsequent EGD to qualify as&#xD;
               surveillance, it needed to occur at least six months after the baseline EGD and&#xD;
               include gastric biopsies collected according to the USSBP; one exception to the USSBP&#xD;
               requirement was if HGD or GA was detected on the surveillance.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Prior history of HGD or any type of gastric malignancy, gastrectomy, or non-gastric&#xD;
               active malignancy.&#xD;
  &#xD;
            -  HGD or GA on the baseline EGD was excluded.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Centro Médico UC-CHRISTUS San Joaquín</name>
        <address>
          <city>Santiago</city>
          <state>Metropolitana</state>
          <country>Chile</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Centro de especialidades médicas Marcoleta UC CHRISTUS</name>
        <address>
          <city>Santiago</city>
          <state>Región Metropolitana</state>
          <country>Chile</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Chile</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>June 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stomach Neoplasms</mesh_term>
      <mesh_term>Gastritis</mesh_term>
      <mesh_term>Gastritis, Atrophic</mesh_term>
      <mesh_term>Atrophy</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol and Statistical Analysis Plan</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>July 10, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT05969444/Prot_SAP_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- 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/NCT05969444
  org study id: 1230504 (AR)
  nct id: NCT05969444
  lead sponsor: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to evaluate the risk factors associated with incident
        HGD/GA in patients with CAG with or without IM who are enrolled in endoscopic surveillance,
        as well as to compare GA incidence according to the OLGA and OLGIM scales in patients 18
        years or older.
  
        . The main questions it aims to answer are:
  
          -  What risk factors are associated with incident HGD/GA in patients with CAG with or
             without IM?
  
          -  What is the comparative HGD/GA incidence according to the OLGA and OLGIM scales?
  The Endoscopic Cohort and Histological OLGA staging (ECHOS) study is a retrospective
        longitudinal cohort developed in the Pontificia Universidad Católica de Chile health care
        system, an open health care system with 3 endoscopic units in Santiago, Chile. Patients 18
        years or older were eligible for the study if they had at least one non-urgent outpatient EGD
        with gastric biopsies collected following the USSBP between June 2015 and June 2021. The
        baseline EGD was defined as the earliest examination conducted between this time frame that
        met inclusion criteria. Participants were included in the cohort if they underwent a
        subsequent "surveillance" EGD. In order for the subsequent EGD to qualify as surveillance, it
        needed to occur at least 6 months after the baseline EGD and include gastric biopsies
        collected according to the USSBP; one exception to the USSBP requirement was if HGD or GA was
        detected on the surveillance (i.e. non-baseline) EGD. Patients with prior history of HGD or
        any type of gastric malignancy, gastrectomy or non-gastric active malignancy were excluded.
        Also, patients with HGD or GA on the baseline EGD were excluded. Patients with indefinite
        (IND) or low-grade dysplasia (LGD) on the baseline EGD were considered for the cohort.
  observational model: Cohort
  time perspective: Retrospective
  measure: High grade dysplasia/Gastric adenocarcinoma
  time frame: At least 6 months between first and second EGD, assessed up to 96 months
  description: Progression from chronic atrophic gastritis or intestinal metaplasia according to baseline Operative Link on Gastritis Assessment (OLGA) staging in baseline measurement to high-grade dysplasia and adenocarcinoma.
  The OLGA uses grades from in tiered scale from 0 to IV, resulting from the combination of atrophic changes (0 = absent; 1 = mild; 2 = moderate; 3 = severe) in the two mucosal compartments (antrum and corpus).
  Gastric mucosa biopsies were obtained following the USSBP as follows:
  
          -  Two tissue samples obtained from the antrum (within 2 to 3 cm from the pylorus, from
             lesser and greater curvature)
  
          -  One sample from the incisura angularis
  
          -  Two samples from the body (one from lesser curvature, ~4 cm proximal from the angle,e
             and one from greater curvature, ~8 cm distal to cardia)
  
          -  Samples from each anatomical location were collected either directed to a suspicious
             endoscopic finding of CAG or IM or following anatomical reference of the protocol if
             apparently normal gastric mucosa was visualized
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  facility: 
  country: Chile
  responsible party type: Sponsor
  mesh term: Stomach Neoplasms
  mesh term: Gastritis
  mesh term: Gastritis, Atrophic
  mesh term: Atrophy
  sharing ipd: No
  provided document: 