xml: <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/NCT05981300</url>
    </required_header>
    <id_info>
      <org_study_id>15-DK-PGpR2</org_study_id>
      <secondary_id>U01DK112194</secondary_id>
      <secondary_id>U01DK112193</secondary_id>
      <secondary_id>U01DK074035</secondary_id>
      <secondary_id>U24DK074008</secondary_id>
      <nct_id>NCT05981300</nct_id>
    </id_info>
    <brief_title>GpCRC Pediatric Gastroparesis Registry 2</brief_title>
    <acronym>PGpR2</acronym>
    <official_title>GpCRC Pediatric Gastroparesis Registry 2: Characterization and Clinical Course of Symptoms and Gastric Emptying in Pediatric, Adolescent, and Young Adult Participants With Symptoms of Gastroparesis</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>
      <collaborator>
        <agency>Texas Tech University Health Sciences Center, El Paso</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Baylor College of Medicine</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Massachusetts General Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Medical College of Wisconsin</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Johns Hopkins Bloomberg School of Public Health</source>
    <oversight_info>
      <has_dmc>Yes</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 the Pediatric Gastroparesis Registry 2 is to create a national prospective&#xD;
        registry of children, adolescents, and young adults with gastroparesis and gastroparesis-like&#xD;
        syndrome (symptoms of gastroparesis but normal gastric emptying).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        An observational study to investigate the natural history and clinical course of children,&#xD;
        adolescents, and young adults with symptoms of gastroparesis (e.g., nausea, vomiting,&#xD;
        abdominal pain, bloating, distention) with either delayed or normal gastric emptying. To&#xD;
        better understand these disorders, this registry will capture demographic, clinical,&#xD;
        physiological, questionnaire, and patient outcome data to characterize the participants and&#xD;
        their clinical course.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">June 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2026</primary_completion_date>
    <study_type>Observational [Patient Registry]</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>
    <target_duration>3 Years</target_duration>
    <primary_outcome>
      <measure>Change in mean symptom severity of gastrointestinal symptoms using the change in total score from the Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Scales™</measure>
      <time_frame>Baseline, 48 weeks</time_frame>
      <description>The PedsQL™ GI Symptoms Scales questionnaire has 65 response items covering 10 dimensions, with each item offered as a better-to-worse 5-point Likert scale choice: 0=never, 1=almost never, 2=sometimes, 3=often, 4=almost always. The item responses are transformed to a worse-to-better order and rescaled to 0-100: 0=almost always, 25= often, 50=sometimes, 75=almost never, 100= never, with higher scores indicating better health-related quality of life (HRQOL) and fewer problems or symptoms.he per-participant PedsQL™ GI Symptoms Scales total score is the sum of the 65 transformed and rescaled item responses. The primary outcome measure is the arithmetic mean of the 65 transformed item responses and is repeated at baseline and 48 weeks for each participant.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Presence or absence of Carnett's sign as assessed by abdominal examination</measure>
      <time_frame>Baseline</time_frame>
      <description>Presence or absence Carnett's sign for abdominal wall pain at baseline. Carnett's sign is a finding on clinical examination in which (acute) abdominal pain remains unchanged or increases when the muscles of the abdominal wall are tensed. As part of the abdominal examination, the patient is asked to lift the head and shoulders from the examination table to tense the abdominal muscles. An alternative is to ask the patient to raise both legs with straight knees.&#xD;
  A positive test indicates the increased likelihood that the abdominal wall and not the abdominal cavity is the source of the pain (for example, due to rectus sheath hematoma instead of appendicitis).&#xD;
  A negative Carnett's sign is said to occur when the abdominal pain decreases when the patient is asked to lift the head; this points to an intra-abdominal cause of the pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in volume (mL) of liquid consumed as assessed by the Water Load Satiety Test</measure>
      <time_frame>Baseline, 48 weeks</time_frame>
      <description>Change from baseline to 48 weeks in amount of liquid (mL) consumed during the Water Load Satiety Test (WLST) Lower volumes are signs of impaired accommodation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Pain Catastrophizing Scale scores (PCS)</measure>
      <time_frame>Baseline, 48 weeks</time_frame>
      <description>The outcome is assessed using change in the total score at 48-weeks minus the baseline score. A negative change indicates reduced pain catastrophizing. PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0 - 52.</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">216</enrollment>
    <condition>Gastroparesis</condition>
    <condition>Gastroparesis-like Syndrome</condition>
    <arm_group>
      <arm_group_label>Ages 8-25 with delayed gastric emptying</arm_group_label>
      <description>Participants aged 8-25 with delayed gastric emptying of solids based on gastric emptying scintigraphy</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Ages 8-25 with normal gastric emptying</arm_group_label>
      <description>Participants aged 8-25 with normal gastric emptying of solids based on gastric emptying scintigraphy</description>
    </arm_group>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Plasma and serum.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          The study population will be 216 participants aged 8-25 years of age with symptoms of Gp&#xD;
          located in the United States.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Provision of signed and dated informed consent form and assent, as age appropriate.&#xD;
  &#xD;
            -  Stated willingness to comply with all study procedures and availability for the&#xD;
               duration of the study&#xD;
  &#xD;
            -  8 to 25 years of age at the time of enrollment&#xD;
  &#xD;
            -  Symptoms of Gp of at least 12 weeks duration: constellation of some combination of:&#xD;
  &#xD;
          nausea, vomiting, early satiety, postprandial fullness; symptoms sometimes may be&#xD;
          accompanied by upper abdominal pain&#xD;
  &#xD;
            -  Have undergone a gastric emptying scintigraphic study of solids using 4-hour Egg&#xD;
               Beaters protocol (or equivalent generic liquid egg white meal) within the last 12&#xD;
               months who fall into one of the two categories:&#xD;
  &#xD;
            -  Delayed gastric emptying-defined as an abnormal 2-hour (&gt;60% retention) and/or 4- hour&#xD;
               (&gt;10% retention) result based on a 4-hour scintigraphic gastric emptying study&#xD;
  &#xD;
            -  Gastric emptying that is not delayed but who have symptoms of Gp (designated in this&#xD;
               study as GLS) or have previously participated in the Pediatric Gastroparesis Registry&#xD;
               (PGpR) study&#xD;
  &#xD;
            -  An etiology of either diabetic or idiopathic Gp or GLS&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inability to comply with or complete the scintigraphic gastric emptying test&#xD;
               (including allergy to eggs)&#xD;
  &#xD;
            -  Pregnancy&#xD;
  &#xD;
            -  Autism spectrum disorder, significant developmental delay, psychosis (because of&#xD;
               inability to complete questionnaires)&#xD;
  &#xD;
            -  Use of narcotic analgesics greater than three days per week.&#xD;
  &#xD;
            -  Presence of conditions associated with GI mucosal disease (e.g., inflammatory bowel&#xD;
               disease, known eosinophilic gastroenteritis or eosinophilic esophagitis, gastric&#xD;
               ulcer, peptic ulcer, celiac disease)&#xD;
  &#xD;
            -  Presence of any other condition that could case delayed gastric emptying&#xD;
  &#xD;
            -  Gastrointestinal construction confirmed by upper endoscopy (EGD), upper&#xD;
               gastrointestinal series (UGI), or abdominal CT&#xD;
  &#xD;
            -  Primary neurological conditions that can cause nausea and vomiting such as increased&#xD;
               intracranial pressure, space occupying or inflammatory/infectious legions&#xD;
  &#xD;
            -  Acute or chronic renal failure (abnormal creatinine for age) and /or on hemodialysis&#xD;
               or peritoneal dialysis&#xD;
  &#xD;
            -  Acute liver failure&#xD;
  &#xD;
            -  Advanced liver disease (features of portal hypertension)&#xD;
  &#xD;
            -  Clinically significant congenital heart disease (i.e., vaginal injury during cardiac&#xD;
               repair)&#xD;
  &#xD;
            -  History of esophageal, gastric or bowel surgery.&#xD;
  &#xD;
            -  Metabolic disease including mitochondrial disease and inborn errors of metabolism&#xD;
  &#xD;
            -  Chronic lung disease (including cystic fibrosis)&#xD;
  &#xD;
            -  A serious chronic medical condition (e.g., inflammatory bowel disease)&#xD;
  &#xD;
            -  Use of medications that can affect motility during the gastric emptying study&#xD;
  &#xD;
            -  Any other condition, which in the option of the investigator, could explain the&#xD;
               symptoms or could interfere with study requirements.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>8 Years</minimum_age>
      <maximum_age>25 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Robert J Shulman, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Baylor College of Medicine</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Laura Miriel</last_name>
      <phone>410-955-4165</phone>
      <email>laura.miriel@jhu.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Peggy Adamo</last_name>
      <phone>410-502-9137</phone>
      <email>madamo1@jhu.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Massachusetts General Hospital</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02114</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Boston Children's Hospital</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02115</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Samuel Nurko, MD</last_name>
        <phone>617-355-6055</phone>
        <email>Samuel.Nurko@childrens.harvard.edu</email>
      </contact>
      <contact_backup>
        <last_name>Andrea Catacora</last_name>
        <phone>857-218-5452</phone>
        <email>andrea.catacora@childrens.harvard.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Samuel Nurko, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Nationwide Children's Hospital</name>
        <address>
          <city>Columbus</city>
          <state>Ohio</state>
          <zip>43205</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Kent Williams, MD</last_name>
        <phone>614-722-3450</phone>
        <email>Kent.Williams@nationwidechildrens.org</email>
      </contact>
      <contact_backup>
        <last_name>Frederick Woodley</last_name>
        <email>frederick.woodley@nationwidechildrens.org</email>
      </contact_backup>
      <investigator>
        <last_name>Kent Williams, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Texas Tech University Health Science Center</name>
        <address>
          <city>El Paso</city>
          <state>Texas</state>
          <zip>79905</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Baylor College of Medicine/Texas Children's Hospital</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77030</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Robert J Shulman, MD</last_name>
        <phone>713-798-7145</phone>
        <email>rshulman@bcm.edu</email>
      </contact>
      <contact_backup>
        <last_name>Heather Charron</last_name>
        <phone>713-798-0381</phone>
        <email>charron@bcm.edu</email>
      </contact_backup>
      <investigator>
        <last_name>Robert J Shulman, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Medical College of Wisconsin</name>
        <address>
          <city>Milwaukee</city>
          <state>Wisconsin</state>
          <zip>53226</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Katja Kovacic, MD</last_name>
        <phone>414-266-3690</phone>
        <email>kkovacic@mcw.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
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    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Functional Disorder of Gastrointestinal Tract</keyword>
    <keyword>Gastro-Intestinal Disorder</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gastroparesis</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05981300
  org study id: 15-DK-PGpR2
  secondary id: U01DK112194
  secondary id: U01DK112193
  secondary id: U01DK074035
  secondary id: U24DK074008
  nct id: NCT05981300
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The objective of the Pediatric Gastroparesis Registry 2 is to create a national prospective
        registry of children, adolescents, and young adults with gastroparesis and gastroparesis-like
        syndrome (symptoms of gastroparesis but normal gastric emptying).
  An observational study to investigate the natural history and clinical course of children,
        adolescents, and young adults with symptoms of gastroparesis (e.g., nausea, vomiting,
        abdominal pain, bloating, distention) with either delayed or normal gastric emptying. To
        better understand these disorders, this registry will capture demographic, clinical,
        physiological, questionnaire, and patient outcome data to characterize the participants and
        their clinical course.
  observational model: Cohort
  time perspective: Prospective
  measure: Change in mean symptom severity of gastrointestinal symptoms using the change in total score from the Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Symptoms Scales™
  time frame: Baseline, 48 weeks
  description: The PedsQL™ GI Symptoms Scales questionnaire has 65 response items covering 10 dimensions, with each item offered as a better-to-worse 5-point Likert scale choice: 0=never, 1=almost never, 2=sometimes, 3=often, 4=almost always. The item responses are transformed to a worse-to-better order and rescaled to 0-100: 0=almost always, 25= often, 50=sometimes, 75=almost never, 100= never, with higher scores indicating better health-related quality of life (HRQOL) and fewer problems or symptoms.he per-participant PedsQL™ GI Symptoms Scales total score is the sum of the 65 transformed and rescaled item responses. The primary outcome measure is the arithmetic mean of the 65 transformed item responses and is repeated at baseline and 48 weeks for each participant.
  measure: Presence or absence of Carnett's sign as assessed by abdominal examination
  time frame: Baseline
  description: Presence or absence Carnett's sign for abdominal wall pain at baseline. Carnett's sign is a finding on clinical examination in which (acute) abdominal pain remains unchanged or increases when the muscles of the abdominal wall are tensed. As part of the abdominal examination, the patient is asked to lift the head and shoulders from the examination table to tense the abdominal muscles. An alternative is to ask the patient to raise both legs with straight knees.
  A positive test indicates the increased likelihood that the abdominal wall and not the abdominal cavity is the source of the pain (for example, due to rectus sheath hematoma instead of appendicitis).
  A negative Carnett's sign is said to occur when the abdominal pain decreases when the patient is asked to lift the head; this points to an intra-abdominal cause of the pain.
  measure: Change in volume (mL) of liquid consumed as assessed by the Water Load Satiety Test
  time frame: Baseline, 48 weeks
  description: Change from baseline to 48 weeks in amount of liquid (mL) consumed during the Water Load Satiety Test (WLST) Lower volumes are signs of impaired accommodation.
  measure: Change in Pain Catastrophizing Scale scores (PCS)
  time frame: Baseline, 48 weeks
  description: The outcome is assessed using change in the total score at 48-weeks minus the baseline score. A negative change indicates reduced pain catastrophizing. PCS total score is computed by summing responses to all 13 items. PCS total scores range from 0 - 52.
  arm group label: Ages 8-25 with delayed gastric emptying
  description: Participants aged 8-25 with delayed gastric emptying of solids based on gastric emptying scintigraphy
  arm group label: Ages 8-25 with normal gastric emptying
  description: Participants aged 8-25 with normal gastric emptying of solids based on gastric emptying scintigraphy
  Plasma and serum.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 8 Years
  maximum age: 25 Years
  healthy volunteers: No
  last name: Robert J Shulman, MD
  role: Study Chair
  affiliation: Baylor College of Medicine
  last name: Laura Miriel
  phone: 410-955-4165
  email: laura.miriel@jhu.edu
  last name: Peggy Adamo
  phone: 410-502-9137
  email: madamo1@jhu.edu
  facility: 
  facility: 
  contact: 
  contact backup: 
  investigator: 
  facility: 
  contact: 
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  investigator: 
  facility: 
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  country: United States
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  responsible party type: Sponsor
  mesh term: Gastroparesis