<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/NCT01727908</url>
  </required_header>
  <id_info>
    <org_study_id>Protocol ID 2012/270</org_study_id>
    <nct_id>NCT01727908</nct_id>
  </id_info>
  <brief_title>Screening for Familial Gastric Cancer in First Degree Relatives</brief_title>
  <acronym>FamGaCan</acronym>
  <official_title>Screening for Familial Gastric Cancer in First Degree Relatives</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Radboud University Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether staining of the gastric mucosa increases&#xD;
      the number of detected (pre)malignant foci of intestinal and diffuse type gastric cancer, in&#xD;
      first degree relatives of individuals with familial gastric cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale:&#xD;
&#xD;
      Familial gastric cancer (FGC) concerns about 10% of all gastric cancers. It has an impressive&#xD;
      impact on both emotional and physical wellbeing of first degree relatives of patients with&#xD;
      (early) onset of gastric cancer. FGC can in 1-3% be attributed to one single hereditary&#xD;
      syndrome, the hereditary diffuse gastric cancer (HDGC). HDGC is associated with a CDH1&#xD;
      mutation in about 40 % of the cases. In case there is no CDH1 mutation, referred to as&#xD;
      familiar diffuse gastric cancer (FDGC), it remains uncertain how to guide and/or screen&#xD;
      family members. The same applies for the rare familial intestinal type gastric cancer (FIGC).&#xD;
&#xD;
      Aim:&#xD;
&#xD;
      In this study we want to determine the value of endoscopic screening in members of families&#xD;
      with FGC, both FDGC and FIGC. Also, we will analyze the associations of life style factors,&#xD;
      including dietary habits with the development of FDGC, to be able to built preventive&#xD;
      strategies. Finally, we want to assess the psychological impact of our screening protocol.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      Primary, to determine whether staining of the gastric mucosa increases the number of detected&#xD;
      (pre)malignant foci of diffuse type gastric cancer, in individuals from families with FDGC as&#xD;
      well as dysplastic, adenomatous and early intestinal cancers in individuals from families&#xD;
      with FIGC. Secondary: A To determine the optimal pathological work-up the detection rate of&#xD;
      (pre-)malignancy. B To determine clinical and life style factors that are associated with the&#xD;
      two types of FGC. C To determine the psychosocial impact of the screening protocol in this&#xD;
      population. D To develop a strategy for screening individuals from FGC families and creative&#xD;
      advise for preventive measures.&#xD;
&#xD;
      Study design:&#xD;
&#xD;
      A randomized controlled trial included in a prospective cohort analysis.&#xD;
&#xD;
      Study population:&#xD;
&#xD;
      All (first degree) relatives , from 18 years and older from patients who fulfill the criteria&#xD;
      for a FGC. These are; 1] all first degree relatives of an individual with diffuse gastric&#xD;
      cancer, without proven CDH1 mutation, or members from families with 2] 2 or more individuals&#xD;
      with gastric carcinoma, at least one &lt; 50 yrs, or 3] 3 or more individuals with gastric&#xD;
      carcinoma, any age, any type, or 4] 1 individual with any type gastric carcinoma &lt; 40 yrs.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    guideline developed&#xD;
  </why_stopped>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The percentage of increasement of endoscopic detection of (pre)malignant for gastric cancer by staining of the gastric mucosa.</measure>
    <time_frame>all patients will have a follow up of five years, during which four endoscopies will be performed</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To determine the optimal pathological work-up the detection rate of (pre-)malignancy, measured by the number of (pre) malignant foci found by the pathologist with different coloring and immunohistochemic techniques.</measure>
    <time_frame>all patients will have a follow up of five years, during which four endoscopies with biopsy sampling will be performed</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the association of clinical and life style factors with the two type of Familial Gastric Cancer, partly assessed from the patients'clinical files (eg BMI), partly by assessment of possible risk factors in blood (eg Helicobacter Pylori).</measure>
    <time_frame>after three years of follow up these data will be assessed</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine the psychosocial impact of the screening protocol in this population, measured as the amount of stress and anxiety by use of the Hospital Anxiety and Distress Scale and the amount of cancer-worry by use of the Cancer Worry Scale.</measure>
    <time_frame>during the follow up period of five years, each patient will receive questionaires at six time points. Assessment of these data will be performed after finishing the follow-up of the last patient, about six years after the start of this study.</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">79</enrollment>
  <condition>Malignant Neoplasm of Stomach</condition>
  <condition>Carcinoma, Diffuse Type</condition>
  <condition>Intestinal Type Adenocarcinoma of Stomach</condition>
  <condition>Relative (Related Person)</condition>
  <arm_group>
    <arm_group_label>Endoscopy without staining of the mucosa</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Endoscopy with staining of the mucosa.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Endoscopy with staining of the mucosa</intervention_name>
    <description>Staining of the gastric mucosa with acetic acid and Indigocarmine</description>
    <arm_group_label>Endoscopy with staining of the mucosa.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult (≥ 18 yrs), female and male relatives&#xD;
&#xD;
          -  fully legal competent (to simplify the common consent agreement for blood withdrawal,&#xD;
             DNA analysis and serial endoscopies.)&#xD;
&#xD;
          -  individuals that signed the common consent agreement&#xD;
&#xD;
          -  first degree relative of an individual with diffuse gastric cancer from a FDGC-family,&#xD;
             without proven mutation,&#xD;
&#xD;
               -  OR: 2 or more individuals with gastric carcinoma, at least one &lt; 50 yrs&#xD;
&#xD;
               -  OR: 3 or more individuals with (diffuse/intestinal/other type) gastric carcinoma,&#xD;
                  any age&#xD;
&#xD;
               -  OR 1 individual with any type gastric carcinoma &lt; 40 yrs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  immature individuals&#xD;
&#xD;
          -  actual gastric ulcer or gastric bleeding&#xD;
&#xD;
          -  previous diagnosis of gastric cancer&#xD;
&#xD;
          -  hypersensitivity to Indigocarmine&#xD;
&#xD;
          -  individuals with co-morbidity which might increase the sedation and/or endoscopy risk:&#xD;
             COPD Gold III/IV Cardiac failure Increased bleeding tendency or use of medication&#xD;
             which increases bleeding tendency&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tanya M Bisseling, M.D.Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Centre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fokko M Nagengast, M.D.Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Gastroenterology and Hepatology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Centre</name>
      <address>
        <city>Nijmegen</city>
        <state>Po Box 9101</state>
        <zip>6500HB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>September 12, 2019</last_update_submitted>
  <last_update_submitted_qc>September 12, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Familial Gastric Cancer Screening</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT01727908
org study id: Protocol ID 2012/270
nct id: NCT01727908
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether staining of the gastric mucosa increases
      the number of detected (pre)malignant foci of intestinal and diffuse type gastric cancer, in
      first degree relatives of individuals with familial gastric cancer.
Rationale:

      Familial gastric cancer (FGC) concerns about 10% of all gastric cancers. It has an impressive
      impact on both emotional and physical wellbeing of first degree relatives of patients with
      (early) onset of gastric cancer. FGC can in 1-3% be attributed to one single hereditary
      syndrome, the hereditary diffuse gastric cancer (HDGC). HDGC is associated with a CDH1
      mutation in about 40 % of the cases. In case there is no CDH1 mutation, referred to as
      familiar diffuse gastric cancer (FDGC), it remains uncertain how to guide and/or screen
      family members. The same applies for the rare familial intestinal type gastric cancer (FIGC).

      Aim:

      In this study we want to determine the value of endoscopic screening in members of families
      with FGC, both FDGC and FIGC. Also, we will analyze the associations of life style factors,
      including dietary habits with the development of FDGC, to be able to built preventive
      strategies. Finally, we want to assess the psychological impact of our screening protocol.

      Objective:

      Primary, to determine whether staining of the gastric mucosa increases the number of detected
      (pre)malignant foci of diffuse type gastric cancer, in individuals from families with FDGC as
      well as dysplastic, adenomatous and early intestinal cancers in individuals from families
      with FIGC. Secondary: A To determine the optimal pathological work-up the detection rate of
      (pre-)malignancy. B To determine clinical and life style factors that are associated with the
      two types of FGC. C To determine the psychosocial impact of the screening protocol in this
      population. D To develop a strategy for screening individuals from FGC families and creative
      advise for preventive measures.

      Study design:

      A randomized controlled trial included in a prospective cohort analysis.

      Study population:

      All (first degree) relatives , from 18 years and older from patients who fulfill the criteria
      for a FGC. These are; 1] all first degree relatives of an individual with diffuse gastric
      cancer, without proven CDH1 mutation, or members from families with 2] 2 or more individuals
      with gastric carcinoma, at least one < 50 yrs, or 3] 3 or more individuals with gastric
      carcinoma, any age, any type, or 4] 1 individual with any type gastric carcinoma < 40 yrs.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: The percentage of increasement of endoscopic detection of (pre)malignant for gastric cancer by staining of the gastric mucosa.
time frame: all patients will have a follow up of five years, during which four endoscopies will be performed
measure: To determine the optimal pathological work-up the detection rate of (pre-)malignancy, measured by the number of (pre) malignant foci found by the pathologist with different coloring and immunohistochemic techniques.
time frame: all patients will have a follow up of five years, during which four endoscopies with biopsy sampling will be performed
measure: To determine the association of clinical and life style factors with the two type of Familial Gastric Cancer, partly assessed from the patients'clinical files (eg BMI), partly by assessment of possible risk factors in blood (eg Helicobacter Pylori).
time frame: after three years of follow up these data will be assessed
measure: To determine the psychosocial impact of the screening protocol in this population, measured as the amount of stress and anxiety by use of the Hospital Anxiety and Distress Scale and the amount of cancer-worry by use of the Cancer Worry Scale.
time frame: during the follow up period of five years, each patient will receive questionaires at six time points. Assessment of these data will be performed after finishing the follow-up of the last patient, about six years after the start of this study.
arm group label: Endoscopy without staining of the mucosa
arm group type: No Intervention
arm group label: Endoscopy with staining of the mucosa.
arm group type: Experimental
intervention type: Other
intervention name: Endoscopy with staining of the mucosa
description: Staining of the gastric mucosa with acetic acid and Indigocarmine
arm group label: Endoscopy with staining of the mucosa.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tanya M Bisseling, M.D.Ph.D.
role: Principal Investigator
affiliation: Department of Gastroenterology and Hepatology, Radboud University Nijmegen Medical Centre
last name: Fokko M Nagengast, M.D.Ph.D.
role: Principal Investigator
affiliation: Department of Gastroenterology and Hepatology
facility: 
country: Netherlands
responsible party type: Sponsor
mesh term: Stomach Neoplasms
mesh term: Neoplasms