<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/NCT03250091</url>
  </required_header>
  <id_info>
    <org_study_id>2915</org_study_id>
    <nct_id>NCT03250091</nct_id>
  </id_info>
  <brief_title>Surveillance of Patients With Precancerous Lesions of the Stomach</brief_title>
  <official_title>Surveillance Strategies of Patients With Precancerous Conditions and Lesions in the Stomach</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Latvia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Digestive Diseases Centre GASTRO</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Riga East Clinical University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Academic Histology Laboratory (Latvia)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Latvia</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 project will aim to identify and determine subgroups of patients with different risks of&#xD;
      progression to gastric cancer and to assess appropriate follow-up intervals. Implementing&#xD;
      risk stratification only high risk individuals will be offered and performed endoscopic&#xD;
      surveillance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gastric cancer is still an important healthcare problem with significant mortality rates.&#xD;
      Latvia is a high incidence country of gastric cancer. Unfortunately most of the gastric&#xD;
      cancer cases in Latvia are diagnosed at late stages when the treatment is substantially less&#xD;
      effective.&#xD;
&#xD;
      Ideally, gastric cancer could be prevented by detecting gastric precancerous&#xD;
      conditions/lesions and identifying those individuals at high-risk of progressing to cancer to&#xD;
      the follow-up.&#xD;
&#xD;
      Population based endoscopic screening for gastric cancer is not recommended for the early&#xD;
      detection of gastric cancer generally deemed not to be cost-effective.&#xD;
&#xD;
      However, in the absence of screening, patients present with advanced disease, and prognosis&#xD;
      is poor.&#xD;
&#xD;
      Targeted endoscopic surveillance strategies for gastric cancer should be introduced following&#xD;
      the principles of the recent European guidelines: Management of precancerous conditions and&#xD;
      lesions in the stomach (MAPS) (Dinis-Ribeiro, Areia et al. 2012).&#xD;
&#xD;
      The project will aim to identify and determine subgroups of patients with different risks of&#xD;
      progression to gastric cancer and to assess appropriate follow-up intervals. Implementing&#xD;
      risk stratification only high risk individuals will be offered endoscopic surveillance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 19, 2017</start_date>
  <completion_date type="Anticipated">December 2027</completion_date>
  <primary_completion_date type="Anticipated">May 2027</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>Risk stratification</measure>
    <time_frame>At baseline</time_frame>
    <description>The patients with material of standardized biopsies according to the standard criteria (updated Sydney system) will be classified in different risk groups for progressing to gastric cancer.&#xD;
The measurements for the risk stratification will be used following the updated Sydney grading and classification system e.g. degree and extent of atrophy, intestinal metaplasia and dysplasia in the stomach mucosa</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Scheduled follow-up procedures (gastroscopies) for high risk group patients</measure>
    <time_frame>At baseline and then 1 and 3 years after the intervention depending on hystopathological report through study completion</time_frame>
    <description>The subgroup of patients at different risk of progression to gastric cancer will be selected and appropriate follow-up intervals will be scheduled and performed. Significant risk stage changes before and after the follow-up upper endoscopy in different research groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastric, faecal microbiome in cancer patients and patients with precancerous lesions</measure>
    <time_frame>At baseline and then 1 and 3 years after the intervention depending on hystopathological report through study completion</time_frame>
    <description>Significant differences in the composition of gastric, faecal microbiome (phyla, genera) in cancer patients and patients with precancerous lesions</description>
  </secondary_outcome>
  <number_of_groups>7</number_of_groups>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Gastric Cancer</condition>
  <condition>Gastric Intestinal Metaplasia</condition>
  <condition>Gastric Atrophy</condition>
  <condition>Gastric Dysplasia</condition>
  <arm_group>
    <arm_group_label>Gastric cancer</arm_group_label>
    <description>Gastric adenocarcinoma and other gastric malignancies</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gastric mucosal dysplasia</arm_group_label>
    <description>Includes: a. High-grade dysplasia; b. Low-grade dysplasia; c. Indefinite for dysplasia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High-risk IM gastritis stages</arm_group_label>
    <description>High-risk stages according to OLGIM classification: OLGIM Stage IV and OLGIM Stage III.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High-risk atrophic gastritis stages</arm_group_label>
    <description>High-risk stages according to OLGA classification: OLGA Stage IV and OLGA Stage III.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Extensive gastric intestinal metaplasia</arm_group_label>
    <description>Intestinal metaplasia of any grade both in gastric corpus and antrum/incisura (other than OLGIM III-IV).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Extensive atrophy</arm_group_label>
    <description>Moderate to severe (++ or +++) atrophy both in corpus and antrum/incisura, other than OLGA III-IV.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Isolated corpus atrophy</arm_group_label>
    <description>Isolated moderate-to-severe atrophy or IM in the corpus.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Upper endoscopy with biopsies</intervention_name>
    <description>Upper endoscopy with proper biopsy work-up will be used for identification and stratification of gastric lesions as well as acquisition of biopsies for histopathological examination, including H.pylori detection</description>
    <arm_group_label>Extensive atrophy</arm_group_label>
    <arm_group_label>Extensive gastric intestinal metaplasia</arm_group_label>
    <arm_group_label>Gastric cancer</arm_group_label>
    <arm_group_label>Gastric mucosal dysplasia</arm_group_label>
    <arm_group_label>High-risk IM gastritis stages</arm_group_label>
    <arm_group_label>High-risk atrophic gastritis stages</arm_group_label>
    <arm_group_label>Isolated corpus atrophy</arm_group_label>
    <other_name>gastroscopy, upper endoscopy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Plasma/serum sampling</intervention_name>
    <description>Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers</description>
    <arm_group_label>Extensive atrophy</arm_group_label>
    <arm_group_label>Extensive gastric intestinal metaplasia</arm_group_label>
    <arm_group_label>Gastric cancer</arm_group_label>
    <arm_group_label>Gastric mucosal dysplasia</arm_group_label>
    <arm_group_label>High-risk IM gastritis stages</arm_group_label>
    <arm_group_label>High-risk atrophic gastritis stages</arm_group_label>
    <arm_group_label>Isolated corpus atrophy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biopsies for gastric microbiota</intervention_name>
    <description>During upper endoscopy biopsies for gastric microbiota analysis will be obtained</description>
    <arm_group_label>Extensive atrophy</arm_group_label>
    <arm_group_label>Extensive gastric intestinal metaplasia</arm_group_label>
    <arm_group_label>Gastric cancer</arm_group_label>
    <arm_group_label>Gastric mucosal dysplasia</arm_group_label>
    <arm_group_label>High-risk IM gastritis stages</arm_group_label>
    <arm_group_label>High-risk atrophic gastritis stages</arm_group_label>
    <arm_group_label>Isolated corpus atrophy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Faecal sample acquisition</intervention_name>
    <description>Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis</description>
    <arm_group_label>Extensive atrophy</arm_group_label>
    <arm_group_label>Extensive gastric intestinal metaplasia</arm_group_label>
    <arm_group_label>Gastric cancer</arm_group_label>
    <arm_group_label>Gastric mucosal dysplasia</arm_group_label>
    <arm_group_label>High-risk IM gastritis stages</arm_group_label>
    <arm_group_label>High-risk atrophic gastritis stages</arm_group_label>
    <arm_group_label>Isolated corpus atrophy</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Human biopsy samples that are used for histopathology analysis are containing human DNA&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The patients with material of standardized biopsies according to the standard criteria&#xD;
        (updated Sydney system) will be classified in different risk groups for progression to&#xD;
        gastric cancer (Group 2-7).&#xD;
&#xD;
        The appropriate follow-up intervals will be scheduled according MAPS guidelines and&#xD;
        follow-up procedures (upper endoscopies) will be performed for each research group (Group&#xD;
        2-7).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients undergoing upper endoscopy Motivation to participate in the study Signed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Known gastric cancer Unwillingness or inability to co-operate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marcis Leja, Prof.,PhD</last_name>
    <role>Study Director</role>
    <affiliation>Institute of Clinical and Preventive Medicine, University of Latvia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ilze Kikuste, PhD</last_name>
    <phone>28357349</phone>
    <phone_ext>+371</phone_ext>
    <email>ikikuste@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Latvia</name>
      <address>
        <city>Riga</city>
        <zip>LV 1586</zip>
        <country>Latvia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ilze Kikuste, PhD</last_name>
      <phone>+317 28357349</phone>
      <email>ikikuste@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Marcis Leja, Prof., PhD</last_name>
      <email>marcis.leja@lu.lv</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Latvia</country>
  </location_countries>
  <reference>
    <citation>Dinis-Ribeiro M, Areia M, de Vries AC, Marcos-Pinto R, Monteiro-Soares M, O'Connor A, Pereira C, Pimentel-Nunes P, Correia R, Ensari A, Dumonceau JM, Machado JC, Macedo G, Malfertheiner P, Matysiak-Budnik T, Megraud F, Miki K, O'Morain C, Peek RM, Ponchon T, Ristimaki A, Rembacken B, Carneiro F, Kuipers EJ; European Society of Gastrointestinal Endoscopy; European Helicobacter Study Group; European Society of Pathology; Sociedade Portuguesa de Endoscopia Digestiva. Management of precancerous conditions and lesions in the stomach (MAPS): guideline from the European Society of Gastrointestinal Endoscopy (ESGE), European Helicobacter Study Group (EHSG), European Society of Pathology (ESP), and the Sociedade Portuguesa de Endoscopia Digestiva (SPED). Endoscopy. 2012 Jan;44(1):74-94. doi: 10.1055/s-0031-1291491. Epub 2011 Dec 23.</citation>
    <PMID>22198778</PMID>
  </reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>July 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>August 20, 2018</last_update_submitted>
  <last_update_submitted_qc>August 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gastric precancerous lesions</keyword>
  <keyword>gastric cancer</keyword>
  <keyword>gastric intestinal Metaplasia</keyword>
  <keyword>gastric atrophy</keyword>
  <keyword>gastric dysplasia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
    <mesh_term>Gastritis, Atrophic</mesh_term>
    <mesh_term>Atrophy</mesh_term>
    <mesh_term>Metaplasia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03250091
org study id: 2915
nct id: NCT03250091
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The project will aim to identify and determine subgroups of patients with different risks of
      progression to gastric cancer and to assess appropriate follow-up intervals. Implementing
      risk stratification only high risk individuals will be offered and performed endoscopic
      surveillance.
Gastric cancer is still an important healthcare problem with significant mortality rates.
      Latvia is a high incidence country of gastric cancer. Unfortunately most of the gastric
      cancer cases in Latvia are diagnosed at late stages when the treatment is substantially less
      effective.

      Ideally, gastric cancer could be prevented by detecting gastric precancerous
      conditions/lesions and identifying those individuals at high-risk of progressing to cancer to
      the follow-up.

      Population based endoscopic screening for gastric cancer is not recommended for the early
      detection of gastric cancer generally deemed not to be cost-effective.

      However, in the absence of screening, patients present with advanced disease, and prognosis
      is poor.

      Targeted endoscopic surveillance strategies for gastric cancer should be introduced following
      the principles of the recent European guidelines: Management of precancerous conditions and
      lesions in the stomach (MAPS) (Dinis-Ribeiro, Areia et al. 2012).

      The project will aim to identify and determine subgroups of patients with different risks of
      progression to gastric cancer and to assess appropriate follow-up intervals. Implementing
      risk stratification only high risk individuals will be offered endoscopic surveillance.
observational model: Cohort
time perspective: Prospective
measure: Risk stratification
time frame: At baseline
description: The patients with material of standardized biopsies according to the standard criteria (updated Sydney system) will be classified in different risk groups for progressing to gastric cancer.
The measurements for the risk stratification will be used following the updated Sydney grading and classification system e.g. degree and extent of atrophy, intestinal metaplasia and dysplasia in the stomach mucosa
measure: Scheduled follow-up procedures (gastroscopies) for high risk group patients
time frame: At baseline and then 1 and 3 years after the intervention depending on hystopathological report through study completion
description: The subgroup of patients at different risk of progression to gastric cancer will be selected and appropriate follow-up intervals will be scheduled and performed. Significant risk stage changes before and after the follow-up upper endoscopy in different research groups.
measure: Gastric, faecal microbiome in cancer patients and patients with precancerous lesions
time frame: At baseline and then 1 and 3 years after the intervention depending on hystopathological report through study completion
description: Significant differences in the composition of gastric, faecal microbiome (phyla, genera) in cancer patients and patients with precancerous lesions
arm group label: Gastric cancer
description: Gastric adenocarcinoma and other gastric malignancies
arm group label: Gastric mucosal dysplasia
description: Includes: a. High-grade dysplasia; b. Low-grade dysplasia; c. Indefinite for dysplasia
arm group label: High-risk IM gastritis stages
description: High-risk stages according to OLGIM classification: OLGIM Stage IV and OLGIM Stage III.
arm group label: High-risk atrophic gastritis stages
description: High-risk stages according to OLGA classification: OLGA Stage IV and OLGA Stage III.
arm group label: Extensive gastric intestinal metaplasia
description: Intestinal metaplasia of any grade both in gastric corpus and antrum/incisura (other than OLGIM III-IV).
arm group label: Extensive atrophy
description: Moderate to severe (++ or +++) atrophy both in corpus and antrum/incisura, other than OLGA III-IV.
arm group label: Isolated corpus atrophy
description: Isolated moderate-to-severe atrophy or IM in the corpus.
intervention type: Procedure
intervention name: Upper endoscopy with biopsies
description: Upper endoscopy with proper biopsy work-up will be used for identification and stratification of gastric lesions as well as acquisition of biopsies for histopathological examination, including H.pylori detection
arm group label: Extensive atrophy
arm group label: Extensive gastric intestinal metaplasia
arm group label: Gastric cancer
arm group label: Gastric mucosal dysplasia
arm group label: High-risk IM gastritis stages
arm group label: High-risk atrophic gastritis stages
arm group label: Isolated corpus atrophy
other name: gastroscopy, upper endoscopy
intervention type: Procedure
intervention name: Plasma/serum sampling
description: Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers
arm group label: Extensive atrophy
arm group label: Extensive gastric intestinal metaplasia
arm group label: Gastric cancer
arm group label: Gastric mucosal dysplasia
arm group label: High-risk IM gastritis stages
arm group label: High-risk atrophic gastritis stages
arm group label: Isolated corpus atrophy
intervention type: Procedure
intervention name: Biopsies for gastric microbiota
description: During upper endoscopy biopsies for gastric microbiota analysis will be obtained
arm group label: Extensive atrophy
arm group label: Extensive gastric intestinal metaplasia
arm group label: Gastric cancer
arm group label: Gastric mucosal dysplasia
arm group label: High-risk IM gastritis stages
arm group label: High-risk atrophic gastritis stages
arm group label: Isolated corpus atrophy
intervention type: Procedure
intervention name: Faecal sample acquisition
description: Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
arm group label: Extensive atrophy
arm group label: Extensive gastric intestinal metaplasia
arm group label: Gastric cancer
arm group label: Gastric mucosal dysplasia
arm group label: High-risk IM gastritis stages
arm group label: High-risk atrophic gastritis stages
arm group label: Isolated corpus atrophy
Human biopsy samples that are used for histopathology analysis are containing human DNA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Marcis Leja, Prof.,PhD
role: Study Director
affiliation: Institute of Clinical and Preventive Medicine, University of Latvia
last name: Ilze Kikuste, PhD
phone: 28357349
phone ext: +371
email: ikikuste@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Latvia
citation: Dinis-Ribeiro M, Areia M, de Vries AC, Marcos-Pinto R, Monteiro-Soares M, O'Connor A, Pereira C, Pimentel-Nunes P, Correia R, Ensari A, Dumonceau JM, Machado JC, Macedo G, Malfertheiner P, Matysiak-Budnik T, Megraud F, Miki K, O'Morain C, Peek RM, Ponchon T, Ristimaki A, Rembacken B, Carneiro F, Kuipers EJ; European Society of Gastrointestinal Endoscopy; European Helicobacter Study Group; European Society of Pathology; Sociedade Portuguesa de Endoscopia Digestiva. Management of precancerous conditions and lesions in the stomach (MAPS): guideline from the European Society of Gastrointestinal Endoscopy (ESGE), European Helicobacter Study Group (EHSG), European Society of Pathology (ESP), and the Sociedade Portuguesa de Endoscopia Digestiva (SPED). Endoscopy. 2012 Jan;44(1):74-94. doi: 10.1055/s-0031-1291491. Epub 2011 Dec 23.
PMID: 22198778
responsible party type: Sponsor
mesh term: Stomach Neoplasms
mesh term: Gastritis, Atrophic
mesh term: Atrophy
mesh term: Metaplasia
sharing ipd: No