<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/NCT03793335</url>
  </required_header>
  <id_info>
    <org_study_id>201811034RINB</org_study_id>
    <nct_id>NCT03793335</nct_id>
  </id_info>
  <brief_title>Individually Tailored Strategies for the Precision Prevention of Gastric Cancer and Colorectal Cancer in the Community</brief_title>
  <official_title>Individually Tailored Strategies for the Precision Prevention of Gastric Cancer and Colorectal Cancer in the Community</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</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>
      Gastric cancer is a global health threat. Helicobacter pylori is now recognized as the main&#xD;
      risk factor that initiates this process; hence, H. pylori eradication has been considered the&#xD;
      most effective method to ameliorate the burden of gastric cancer. Serum pepsinogen levels&#xD;
      reveal the current atrophy of the stomach and predict gastric cancer risk. A risk prediction&#xD;
      model with the combination of H. pylori infection and serum pepsinogen level could identify&#xD;
      the highest-risk gastric cancer patients.&#xD;
&#xD;
      Colorectal cancers (CRC) rank second and third as the leading causes of cancer-related death&#xD;
      in men and women, respectively. For CRC prevention, a two-stage approach using the fecal&#xD;
      immunochemical test (FIT) is popular; besides, the FIT levels may serve as a guide for&#xD;
      priority setting in prompting residents to undergo colonoscopy. Therefore, the effectiveness&#xD;
      and utility of aggressive referral confirmatory diagnosis protocol in a colorectal cancer&#xD;
      screening program for those with high FIT levels urgently need to evaluate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Gastric cancer is a global health threat and contributes to more than 720,000 deaths per&#xD;
      year. In the absence of early detection, gastric cancer is associated with a high fatality&#xD;
      rate-the 5-year survival rate for patients with locally advanced disease is only about 40%&#xD;
      despite aggressive treatment. Carcinogenesis in gastric cancer follows a multistage process&#xD;
      (i.e., Correa's model) that develops from chronic active gastritis to atrophic gastritis,&#xD;
      intestinal metaplasia, dysplasia, and finally to carcinoma. Helicobacter pylori is now&#xD;
      recognized as the main risk factor that initiates this process. An estimated 89% of&#xD;
      non-cardiac cancers can be prevented if H. pylori can be eradicated from the population of&#xD;
      interest; hence, H. pylori eradication has been considered the most effective method to&#xD;
      ameliorate the burden of gastric cancer. However, in the setting of mass screening,&#xD;
      irreversible damage may already have occurred after patients have harbored H. pylori&#xD;
      infection for decades before they undergo screening and treatment for H. pylori. This&#xD;
      observation has been supported by a recent meta-analysis based on 8 randomized controlled&#xD;
      trials and 16 cohort studies that investigated the magnitude of the benefit from eradication&#xD;
      therapy; on average, only a 50% reduction of gastric cancer risk was shown. Altered levels of&#xD;
      serum pepsinogens, which are mainly produced by the chief cells of the fundic glands of the&#xD;
      stomach, reflect the atrophic status (ie, gland loss) of gastric mucosa. Serum pepsinogen&#xD;
      levels not only reveal the past infection status or current atrophy of the stomach,&#xD;
      respectively, but have also been shown to be predictive of gastric cancer risk. Therefore, to&#xD;
      completely eliminate the burden of gastric cancer, physicians urgently need a risk prediction&#xD;
      model with the combination of H. pylori infection and serum pepsinogen level to identify the&#xD;
      highest-risk patients for endoscopic examination in the context of limited resources.&#xD;
&#xD;
      Colorectal cancers (CRC) rank second and third as the leading causes of cancer-related death&#xD;
      in men and women, respectively, in the world. To reduce the burden of CRC, colonoscopy is the&#xD;
      most effective method and can reduce the risk of new-onset CRCs by the removal of adenomatous&#xD;
      polyps and can improve CRC survival by the detection of pre-symptomatic malignancies. In&#xD;
      addition to primary screening colonoscopy, a two-stage approach using the fecal&#xD;
      immunochemical test (FIT) is increasingly popular because of its ability to identify patients&#xD;
      with the highest risk of CRC; in this manner, limited colonoscopist resources can be&#xD;
      efficiently allocated. Although colonoscopy is associated with a statistically significant&#xD;
      reduction in mortality rates for CRC through the detection of early-stage cancers, the FIT&#xD;
      levels may serve as a guide for priority setting in prompting residents to undergo&#xD;
      colonoscopy. Besides, the prevalence of any CRC and advanced-stage CRC is associated with&#xD;
      delays in follow-up colonoscopies for patients with positive results from a FIT. Therefore,&#xD;
      the effectiveness and utility of aggressive referral confirmatory diagnosis protocol in a&#xD;
      colorectal cancer screening program for those with high FIT levels urgently need to evaluate.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">April 14, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2029</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Gastric cancer prevention</measure>
    <time_frame>Up to 10 years, the gastric cancer incidence per 100,000 person-years is calculated by the person-years of follow-up.</time_frame>
    <description>To assess the combination of H. pylori stool antigen test and serum pepsinogen test as a joint predictor of gastric cancer risk</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Colorectal cancer prevention</measure>
    <time_frame>Up to 10 years, the colorectal cancer incidence per 100,000 person-years is calculated by the person-years of follow-up.</time_frame>
    <description>To assess the effectiveness/utility of aggressive referral confirmatory diagnosis protocol in a colorectal cancer screening program</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">40000</enrollment>
  <condition>Gastric Cancer</condition>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Gastric cancer prevention</arm_group_label>
    <description>This prospective study consists of 40,000 participants; after randomization, each arm has 20,000 participants. Arm 1: participants receive H. pylori stool antigen test; Arm 2: participants receive the combination of H. pylori stool antigen test and serum pepsinogen test.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Colorectal cancer prevention</arm_group_label>
    <description>This prospective study consists of 40,000 participants; after randomization; each arm has 20,000 participants. Arm 1: participants with positive fecal immunochemical test (FIT) receive routine referral confirmatory diagnosis approach; Arm 2: participants with positive FIT receive routine referral confirmatory diagnosis approach and participants with high FIT results receive additional aggressive referral confirmatory diagnosis approach.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        A community-based mass screening for gastric cancer and colorectal cancer is designed and&#xD;
        targeted at community residents aged 50-75 years in Taiwan.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged 50-75 years&#xD;
&#xD;
          2. Confirmed non-gastric cancer/colorectal cancer healthy participant&#xD;
&#xD;
          3. Mentally competent to be able to understand the consent form&#xD;
&#xD;
          4. Able to communicate with study staff for individuals&#xD;
&#xD;
          5. Agree to link the screening data to National Cancer Registry&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Confirmed gastric cancer/colorectal cancer healthy participant&#xD;
&#xD;
          2. Status post gastrectomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>TSUNG-HSIEN CHIANG, MD, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</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>Colorectal Neoplasms</mesh_term>
    <mesh_term>Stomach Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No individual participant data could be shared.</ipd_description>
  </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/NCT03793335
org study id: 201811034RINB
nct id: NCT03793335
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Gastric cancer is a global health threat. Helicobacter pylori is now recognized as the main
      risk factor that initiates this process; hence, H. pylori eradication has been considered the
      most effective method to ameliorate the burden of gastric cancer. Serum pepsinogen levels
      reveal the current atrophy of the stomach and predict gastric cancer risk. A risk prediction
      model with the combination of H. pylori infection and serum pepsinogen level could identify
      the highest-risk gastric cancer patients.

      Colorectal cancers (CRC) rank second and third as the leading causes of cancer-related death
      in men and women, respectively. For CRC prevention, a two-stage approach using the fecal
      immunochemical test (FIT) is popular; besides, the FIT levels may serve as a guide for
      priority setting in prompting residents to undergo colonoscopy. Therefore, the effectiveness
      and utility of aggressive referral confirmatory diagnosis protocol in a colorectal cancer
      screening program for those with high FIT levels urgently need to evaluate.
Gastric cancer is a global health threat and contributes to more than 720,000 deaths per
      year. In the absence of early detection, gastric cancer is associated with a high fatality
      rate-the 5-year survival rate for patients with locally advanced disease is only about 40%
      despite aggressive treatment. Carcinogenesis in gastric cancer follows a multistage process
      (i.e., Correa's model) that develops from chronic active gastritis to atrophic gastritis,
      intestinal metaplasia, dysplasia, and finally to carcinoma. Helicobacter pylori is now
      recognized as the main risk factor that initiates this process. An estimated 89% of
      non-cardiac cancers can be prevented if H. pylori can be eradicated from the population of
      interest; hence, H. pylori eradication has been considered the most effective method to
      ameliorate the burden of gastric cancer. However, in the setting of mass screening,
      irreversible damage may already have occurred after patients have harbored H. pylori
      infection for decades before they undergo screening and treatment for H. pylori. This
      observation has been supported by a recent meta-analysis based on 8 randomized controlled
      trials and 16 cohort studies that investigated the magnitude of the benefit from eradication
      therapy; on average, only a 50% reduction of gastric cancer risk was shown. Altered levels of
      serum pepsinogens, which are mainly produced by the chief cells of the fundic glands of the
      stomach, reflect the atrophic status (ie, gland loss) of gastric mucosa. Serum pepsinogen
      levels not only reveal the past infection status or current atrophy of the stomach,
      respectively, but have also been shown to be predictive of gastric cancer risk. Therefore, to
      completely eliminate the burden of gastric cancer, physicians urgently need a risk prediction
      model with the combination of H. pylori infection and serum pepsinogen level to identify the
      highest-risk patients for endoscopic examination in the context of limited resources.

      Colorectal cancers (CRC) rank second and third as the leading causes of cancer-related death
      in men and women, respectively, in the world. To reduce the burden of CRC, colonoscopy is the
      most effective method and can reduce the risk of new-onset CRCs by the removal of adenomatous
      polyps and can improve CRC survival by the detection of pre-symptomatic malignancies. In
      addition to primary screening colonoscopy, a two-stage approach using the fecal
      immunochemical test (FIT) is increasingly popular because of its ability to identify patients
      with the highest risk of CRC; in this manner, limited colonoscopist resources can be
      efficiently allocated. Although colonoscopy is associated with a statistically significant
      reduction in mortality rates for CRC through the detection of early-stage cancers, the FIT
      levels may serve as a guide for priority setting in prompting residents to undergo
      colonoscopy. Besides, the prevalence of any CRC and advanced-stage CRC is associated with
      delays in follow-up colonoscopies for patients with positive results from a FIT. Therefore,
      the effectiveness and utility of aggressive referral confirmatory diagnosis protocol in a
      colorectal cancer screening program for those with high FIT levels urgently need to evaluate.
observational model: Ecologic or Community
time perspective: Prospective
measure: Gastric cancer prevention
time frame: Up to 10 years, the gastric cancer incidence per 100,000 person-years is calculated by the person-years of follow-up.
description: To assess the combination of H. pylori stool antigen test and serum pepsinogen test as a joint predictor of gastric cancer risk
measure: Colorectal cancer prevention
time frame: Up to 10 years, the colorectal cancer incidence per 100,000 person-years is calculated by the person-years of follow-up.
description: To assess the effectiveness/utility of aggressive referral confirmatory diagnosis protocol in a colorectal cancer screening program
arm group label: Gastric cancer prevention
description: This prospective study consists of 40,000 participants; after randomization, each arm has 20,000 participants. Arm 1: participants receive H. pylori stool antigen test; Arm 2: participants receive the combination of H. pylori stool antigen test and serum pepsinogen test.
arm group label: Colorectal cancer prevention
description: This prospective study consists of 40,000 participants; after randomization; each arm has 20,000 participants. Arm 1: participants with positive fecal immunochemical test (FIT) receive routine referral confirmatory diagnosis approach; Arm 2: participants with positive FIT receive routine referral confirmatory diagnosis approach and participants with high FIT results receive additional aggressive referral confirmatory diagnosis approach.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 50 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: TSUNG-HSIEN CHIANG, MD, MSc
role: Principal Investigator
affiliation: National Taiwan University Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Colorectal Neoplasms
mesh term: Stomach Neoplasms
sharing ipd: No
ipd description: No individual participant data could be shared.