<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/NCT01696747</url>
  </required_header>
  <id_info>
    <org_study_id>GpCRC-GpR 2-5</org_study_id>
    <secondary_id>U01DK073974</secondary_id>
    <secondary_id>U01DK073975</secondary_id>
    <secondary_id>U01DK073983</secondary_id>
    <secondary_id>U01DK073985</secondary_id>
    <secondary_id>U01DK074007</secondary_id>
    <secondary_id>U01DK074008</secondary_id>
    <nct_id>NCT01696747</nct_id>
  </id_info>
  <brief_title>Gastroparesis Registry 2</brief_title>
  <acronym>GpR2</acronym>
  <official_title>GpR 2: Continuation of the NIDDK Gastroparesis Registry for the Characterization and Clinical Course of Gastroparesis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins Bloomberg School of Public Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Johns Hopkins Bloomberg School of Public Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To expand a registry of patients for the study of the epidemiology, etiology, and degree of&#xD;
      morbidity associated with gastroparesis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Gastroparesis Registry 2 (GpR 2) will enroll new patients and patients from the initial&#xD;
      NIDDK Gastroparesis Clinical Research Consortium Gastroparesis Registry (GpR) of&#xD;
      gastroparesis patients which was initiated in February 2007 and completed in March 2011.&#xD;
&#xD;
      To continue to follow and expand the data collections of a well-characterized cohort to&#xD;
      further define the natural history and clinical course of gastroparesis.&#xD;
&#xD;
      To provide a reliable source for recruitment of well-characterized patients with&#xD;
      gastroparesis for therapeutic clinical trials, pathophysiological, molecular,&#xD;
      histopathologic, or other ancillary studies. These subsequent clinical trials or ancillary&#xD;
      studies will be conducted under separate study protocols with separate consent processes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2012</start_date>
  <completion_date type="Actual">April 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</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>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">506</enrollment>
  <condition>Gastroparesis</condition>
  <condition>Diabetic Gastroparesis</condition>
  <condition>Idiopathic Gastroparesis</condition>
  <arm_group>
    <arm_group_label>Diabetic</arm_group_label>
    <description>participants with a primary etiology of diabetic gastroparesis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Idiopathic</arm_group_label>
    <description>participants with a primary etiology of idiopathic gastroparesis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Post-Nissen</arm_group_label>
    <description>participants with a primary etiology of post-Nissen fundoplication gastroparesis</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      plasma serum DNA&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        This study will enroll patients with gastroparesis and delayed gastric emptying. These&#xD;
        patients can have either diabetic, idiopathic, or post-Nissen fundoplication gastroparesis.&#xD;
        In addition, patients with symptoms similar to gastroparesis, but with normal gastric&#xD;
        emptying will be enrolled as a reference group.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Symptoms of gastroparesis of at least 12 weeks duration (do not have to be contiguous)&#xD;
             with varying degrees of nausea, vomiting, early satiety, post-prandial fullness,&#xD;
             and/or abdominal pain&#xD;
&#xD;
          -  An etiology of either diabetic, idiopathic, or post-Nissen fundoplication&#xD;
             gastroparesis&#xD;
&#xD;
          -  Gastric emptying scintigraphy of solids and liquids test using 4 hours Egg Beaters®&#xD;
             protocol within the last 6 months with either:&#xD;
&#xD;
               -  Abnormal gastric emptying rate defined as an abnormal 2 hour (&gt;60% retention)&#xD;
                  and/or 4 hour (&gt;10% retention) result based on a 4-hour scintigraphic low fat Egg&#xD;
                  Beaters® gastric emptying study performed at a GpCRC clinical center.&#xD;
&#xD;
               -  Patients with a normal gastric emptying rate but with symptoms of gastroparesis&#xD;
                  may be enrolled and classified as possible gastroparesis or gastroparesis-like&#xD;
                  with normal gastric emptying&#xD;
&#xD;
          -  Age at least 18 years at initial screening visit&#xD;
&#xD;
          -  Upper endoscopy results within last 2 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to comply with or complete the gastric emptying scintigraphy test (including&#xD;
             allergy to eggs)&#xD;
&#xD;
          -  Presence of other conditions that could explain the patient's symptoms:&#xD;
&#xD;
          -  Pyloric or intestinal obstruction as determined by endoscopy, upper GI series or&#xD;
             abdominal CT scan&#xD;
&#xD;
          -  Active inflammatory bowel disease&#xD;
&#xD;
          -  Known eosinophilic gastroenteritis&#xD;
&#xD;
          -  Primary neurological conditions that could cause nausea and/or vomiting such as&#xD;
             increased intracranial pressure, space occupying or inflammatory/infectious lesions&#xD;
&#xD;
          -  Acute liver failure&#xD;
&#xD;
          -  Advanced liver disease (Child's B or C; a Child-Pugh-Turcotte (CPT) score of ≥7 )&#xD;
&#xD;
          -  Acute renal failure&#xD;
&#xD;
          -  Chronic renal failure (serum creatinine &gt;3 mg/dL) and/or on hemodialysis or peritoneal&#xD;
             dialysis&#xD;
&#xD;
          -  Total or subtotal (near complete) gastric resection, esophagogastrostomy,&#xD;
             gastrojejunostomy, or gastric bypass. Note: patients with prior fundoplication will be&#xD;
             eligible for enrollment.&#xD;
&#xD;
          -  Any other plausible structural or metabolic cause&#xD;
&#xD;
          -  Any other condition, which in the opinion of the investigator would interfere with&#xD;
             study requirements&#xD;
&#xD;
          -  Inability to obtain informed consent&#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>Frank Hamilton, MD, MPH</last_name>
    <role>Study Director</role>
    <affiliation>National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Louisville</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins Bayview Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital-Digestive Healthcare Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest University Health Sciences</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Temple University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Tech University Health Sciences Center</name>
      <address>
        <city>El Paso</city>
        <state>Texas</state>
        <zip>79905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://jhuccs1.us/gpcrc/</url>
    <description>Gastroparesis Clinical Research Consortium</description>
  </link>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <last_update_submitted>February 7, 2022</last_update_submitted>
  <last_update_submitted_qc>February 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gastroparesis</keyword>
  <keyword>idiopathic gastroparesis</keyword>
  <keyword>diabetic gastroparesis</keyword>
  <keyword>post-Nissen gastroparesis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroparesis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data to be shared at end of funding</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/NCT01696747
org study id: GpCRC-GpR 2-5
secondary id: U01DK073974
secondary id: U01DK073975
secondary id: U01DK073983
secondary id: U01DK073985
secondary id: U01DK074007
secondary id: U01DK074008
nct id: NCT01696747
lead sponsor: 
collaborator: 
has dmc: Yes
To expand a registry of patients for the study of the epidemiology, etiology, and degree of
      morbidity associated with gastroparesis.
The Gastroparesis Registry 2 (GpR 2) will enroll new patients and patients from the initial
      NIDDK Gastroparesis Clinical Research Consortium Gastroparesis Registry (GpR) of
      gastroparesis patients which was initiated in February 2007 and completed in March 2011.

      To continue to follow and expand the data collections of a well-characterized cohort to
      further define the natural history and clinical course of gastroparesis.

      To provide a reliable source for recruitment of well-characterized patients with
      gastroparesis for therapeutic clinical trials, pathophysiological, molecular,
      histopathologic, or other ancillary studies. These subsequent clinical trials or ancillary
      studies will be conducted under separate study protocols with separate consent processes.
observational model: Cohort
time perspective: Prospective
arm group label: Diabetic
description: participants with a primary etiology of diabetic gastroparesis
arm group label: Idiopathic
description: participants with a primary etiology of idiopathic gastroparesis
arm group label: Post-Nissen
description: participants with a primary etiology of post-Nissen fundoplication gastroparesis
plasma serum DNA
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Frank Hamilton, MD, MPH
role: Study Director
affiliation: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: https://jhuccs1.us/gpcrc/
description: Gastroparesis Clinical Research Consortium
responsible party type: Sponsor
mesh term: Gastroparesis
sharing ipd: Yes
ipd description: Data to be shared at end of funding