<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/NCT03005080</url>
  </required_header>
  <id_info>
    <org_study_id>16-007265</org_study_id>
    <nct_id>NCT03005080</nct_id>
  </id_info>
  <brief_title>Pharmacogenetic Testing in Children With Persistent Gastroesophageal Reflux Disease</brief_title>
  <official_title>The Utility of Pharmacogenetic Testing in Managing Children With Persistent Gastroesophageal Reflux Disease Despite Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will use a 22 gene pharmacogenomics panel on 30 children with persistent&#xD;
      Gastroesophageal Reflux Disease (GERD) who have not responded to therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will assess the clinical utility of pharmacogenomics testing in the clinical&#xD;
      management of children with refractory GERD, despite adequate therapy and the role of&#xD;
      pharmacogenomics in selecting the right acid suppressive therapy based on each patient's&#xD;
      symptoms and pharmacogenomics results.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">October 2018</completion_date>
  <primary_completion_date type="Actual">December 2017</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>Number of subjects who change medication due to pharmacogenomic results</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of subjects who have a repeat scope</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <enrollment type="Actual">51</enrollment>
  <condition>Gastroesophageal Reflux</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Children &lt;18 years of age&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  persistent gastrointestinal symptoms (GI) suggestive of gastro esophageal reflux&#xD;
             disease (GERD) despite adequate therapy&#xD;
&#xD;
          -  persistent evidence of abnormal reflux indices' and acid exposure on esophageal&#xD;
             multichannel pH impedance study despite adequate therapy&#xD;
&#xD;
          -  persistent endoscopic evidence of reflux esophageal disease despite adequate therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  children with eosinophilic esophagitis diagnosis&#xD;
&#xD;
          -  children with any esophageal surgical intervention like fundoplication,&#xD;
             tracheoespahgeal fistula repair or esophageal atresia repair&#xD;
&#xD;
          -  children with other diseases that can affect the esophagus, like Crohn's disease or&#xD;
             food protein-induced enterocolitis syndrome (F-PIES)&#xD;
&#xD;
          -  Children who do not have research authorization in their chart&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>December 23, 2016</study_first_submitted>
  <study_first_submitted_qc>December 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>April 5, 2019</last_update_submitted>
  <last_update_submitted_qc>April 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Imad Absah</investigator_full_name>
    <investigator_title>Imad Absah, M.D.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroesophageal Reflux</mesh_term>
    <mesh_term>Esophagitis, Peptic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03005080
org study id: 16-007265
nct id: NCT03005080
lead sponsor: 
has dmc: No
This study will use a 22 gene pharmacogenomics panel on 30 children with persistent
      Gastroesophageal Reflux Disease (GERD) who have not responded to therapy.
This study will assess the clinical utility of pharmacogenomics testing in the clinical
      management of children with refractory GERD, despite adequate therapy and the role of
      pharmacogenomics in selecting the right acid suppressive therapy based on each patient's
      symptoms and pharmacogenomics results.
observational model: Cohort
time perspective: Prospective
measure: Number of subjects who change medication due to pharmacogenomic results
time frame: 12 weeks
measure: Number of subjects who have a repeat scope
time frame: 12 weeks
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Imad Absah
investigator title: Imad Absah, M.D.
mesh term: Gastroesophageal Reflux
mesh term: Esophagitis, Peptic
sharing ipd: Undecided