<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/NCT02970110</url>
  </required_header>
  <id_info>
    <org_study_id>HPY-COL-001</org_study_id>
    <nct_id>NCT02970110</nct_id>
  </id_info>
  <brief_title>Specimen Collection Study for H. Pylori Testing</brief_title>
  <official_title>Specimen Collection Study for H. Pylori Testing in Patients With Dyspepsia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biomerica</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biomerica</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 objective of this study is to acquire human specimens from subjects undergoing routine&#xD;
      endoscopy with gastric biopsy for the diagnosis of active H. pylori infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective study designed to acquire and bank human specimens from subjects who&#xD;
      are scheduled for routine upper endoscopy for symptoms such as dyspepsia. This study will be&#xD;
      conducted at a minimum of 2 sites in the United States. Investigator sites will enroll&#xD;
      prospective subjects who meet the inclusion / exclusion criteria. A case report form (CRF)&#xD;
      provided by the sponsor will be used to capture basic demographic information (DOB, age,&#xD;
      gender, race/ethnicity), medication history, and related clinical information. The CRFs will&#xD;
      also record the results of the following tests performed with the gastric biopsy tissue&#xD;
      specimens: histology and rapid urease test (RUT).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 27, 2017</start_date>
  <completion_date type="Actual">March 1, 2020</completion_date>
  <primary_completion_date type="Actual">March 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Non-invasive collection procedure</measure>
    <time_frame>1 year</time_frame>
    <description>This study is designed to collect specimens to supplement repository specimens for product validation purposes. The endoscopy results and specimens will be used in a future clinical trial of a non-invasive in vitro diagnostic assay for the detection of H. pylori antigen. institutional review board approval is sought in order to be able to use human specimens for validation of in vitro diagnostics.</description>
  </primary_outcome>
  <enrollment type="Actual">98</enrollment>
  <condition>Helicobacter Infections</condition>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Biospecimen&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will consist of subjects scheduled for routine upper endoscopy for&#xD;
        upper gastrointestinal tract symptoms such as dyspepsia. All prospective subjects must be&#xD;
        off of proton-pump inhibitors, antibiotics, and bismuth for at least 2 weeks prior to&#xD;
        submission of the stool specimen and undergoing endoscopy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 21 and to 75 years.&#xD;
&#xD;
          -  Able to read, speak, and understand English or have access to a translator in&#xD;
             subject's native language.&#xD;
&#xD;
          -  Patients without prior H. pylori eradication treatment.&#xD;
&#xD;
          -  Currently not on proton pump inhibitors, antibiotics or bismuth&#xD;
&#xD;
               -  Discontinuation at least 2 weeks prior to endoscopy and specimen collection.&#xD;
&#xD;
          -  Present with signs and symptoms of dyspepsia [e.g. upper abdominal discomfort or pain]&#xD;
&#xD;
          -  Undergo gastric biopsies as part of routine care&#xD;
&#xD;
          -  Physician able to provide histology and rapid urease result on biopsy specimens.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Aged less than 21 years old or older than 75 years&#xD;
&#xD;
          -  Unable to provide consent.&#xD;
&#xD;
          -  Patients with a history of prior H. pylori eradication therapy.&#xD;
&#xD;
          -  Currently on proton pump inhibitors, antibiotics or bismuth and cannot or will not&#xD;
             discontinue&#xD;
&#xD;
          -  Previous upper gastrointestinal surgery, such as bariatric surgery, Nissen&#xD;
             fundoplication, or Roux-en-Y.&#xD;
&#xD;
          -  Any unstable or poorly-controlled medical or psychiatric condition.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James R Buxbaum, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California, Los Angeles County Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Del Sol Research Management, Inc.</name>
      <address>
        <city>Tucson</city>
        <state>Arizona</state>
        <zip>85712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medley Research Associates</name>
      <address>
        <city>Medley</city>
        <state>Florida</state>
        <zip>33166</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212-1610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>March 16, 2022</last_update_submitted>
  <last_update_submitted_qc>March 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2022</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>Helicobacter Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Demographics including age, gender, geographical location, histology and RUT results collected in this study will be shared with researchers involved with a future evaluation of an in vitro diagnostic device product in development at Biomerica.</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/NCT02970110
org study id: HPY-COL-001
nct id: NCT02970110
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to acquire human specimens from subjects undergoing routine
      endoscopy with gastric biopsy for the diagnosis of active H. pylori infection.
This is a prospective study designed to acquire and bank human specimens from subjects who
      are scheduled for routine upper endoscopy for symptoms such as dyspepsia. This study will be
      conducted at a minimum of 2 sites in the United States. Investigator sites will enroll
      prospective subjects who meet the inclusion / exclusion criteria. A case report form (CRF)
      provided by the sponsor will be used to capture basic demographic information (DOB, age,
      gender, race/ethnicity), medication history, and related clinical information. The CRFs will
      also record the results of the following tests performed with the gastric biopsy tissue
      specimens: histology and rapid urease test (RUT).
observational model: Case-Only
time perspective: Prospective
measure: Non-invasive collection procedure
time frame: 1 year
description: This study is designed to collect specimens to supplement repository specimens for product validation purposes. The endoscopy results and specimens will be used in a future clinical trial of a non-invasive in vitro diagnostic assay for the detection of H. pylori antigen. institutional review board approval is sought in order to be able to use human specimens for validation of in vitro diagnostics.
Biospecimen
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: No
last name: James R Buxbaum, M.D.
role: Principal Investigator
affiliation: University of Southern California, Los Angeles County Hospital
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Helicobacter Infections
sharing ipd: No
ipd description: Demographics including age, gender, geographical location, histology and RUT results collected in this study will be shared with researchers involved with a future evaluation of an in vitro diagnostic device product in development at Biomerica.