<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/NCT01699516</url>
  </required_header>
  <id_info>
    <org_study_id>IRB33982</org_study_id>
    <nct_id>NCT01699516</nct_id>
  </id_info>
  <brief_title>Non-invasive Contrast Enhanced Ultrasound Sonography in Intestinal Acute Graft-vs-Host Disease</brief_title>
  <official_title>A Prospective Study on Qualitative and Quantitative Non-invasive Evaluation of Intestinal Acute Graft-vs-host Disease by Contrast Enhanced Ultrasound Sonography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pisa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pisa</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Intestinal acute graft-vs-host disease (GVHD) is a life-threatening complication after&#xD;
      allogeneic hematopoietic cell transplantation. Non-invasive diagnostic procedures are still&#xD;
      lacking and diagnosis is difficult. We hypothesized that contrast-enhanced ultrasound&#xD;
      sonography (CEUS) could detect microcirculation changes of the bowel walls during intestinal&#xD;
      GVHD and help to detect and monitor treatment response. We employed CEUS to prospectively&#xD;
      evaluate intestinal GVHD in 83 consecutive transplant patients between 2008 and 2011.&#xD;
      Fourteen /83 patients with biopsy-proven intestinal GVHD were selected as study group.&#xD;
      Fourteen patients with biopsy-proven stomach GVHD without intestinal symptoms (N=16), normal&#xD;
      volunteers (N=6) and patients with neutropenic enterocolitis (N=4), were chosen as control&#xD;
      group. All patients were evaluated with both standard transabdominal ultrasonography (US) and&#xD;
      CEUS at the onset of intestinal symptoms, during clinical follow up and at flare of symptoms.&#xD;
      Standard US revealed non-specific bowel wall thickening, and simultaneous involvement of&#xD;
      multiple intestinal segments in 9/14 patients. CEUS showed three distinct patterns of&#xD;
      microcirculation changes that correlated with GVHD activity. These findings were not observed&#xD;
      in the control group. Moreover, CEUS findings correlated with treatment response and&#xD;
      predicted flare of intestinal symptoms. CEUS is a non-invasive, easily reproducible bed-side&#xD;
      tool to detect and monitor intestinal GVHD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2008</start_date>
  <primary_completion_date type="Actual">May 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">32</enrollment>
  <condition>Intestinal GVHD</condition>
  <condition>Neutropenic Enterocolitis</condition>
  <arm_group>
    <arm_group_label>Intestinal graft vs host disease</arm_group_label>
    <description>Patients with biopsy-proven intestinal acute GVHD in the setting of an allogenic transplant</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>In the setting of an allogenic bone marrow transplant: patients with biopsy-proven stomach GVHD without intestinal symptoms and patients with neutropenic enterocolitis. Normal volunteers.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        In the setting of allogenic transplant: intestinal acute graft vs host disease (GVHD),&#xD;
        stomach GVHD, neutropenic enterocolitis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Bone Marrow Transplant&#xD;
&#xD;
          -  intestinal acute graft versus host disease&#xD;
&#xD;
          -  stomach GVHD&#xD;
&#xD;
          -  neutropenic enterocolitis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        no biopsy proven intestinal or stomach GVHD no neutropenic enterocolitis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>66 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Edoardo Benedetti, MD</last_name>
    <phone>+39050993</phone>
    <phone_ext>085</phone_ext>
    <email>edobenedetti@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Santa Chiara Hospital University of Pisa</name>
      <address>
        <city>Pisa</city>
        <zip>56127</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Edoardo Benedetti, MD</last_name>
      <phone>+39050993</phone>
      <phone_ext>085</phone_ext>
      <email>edobenedetti@gmail.com</email>
    </contact>
    <investigator>
      <last_name>Edoardo Benedetti, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 1, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2012</study_first_posted>
  <last_update_submitted>October 1, 2012</last_update_submitted>
  <last_update_submitted_qc>October 1, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 3, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pisa</investigator_affiliation>
    <investigator_full_name>Dr Edoardo Benedetti</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>allogeneic transplantation; intestinal graft-vs.-host disease; contrast enhanced ultrasound sonography</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Enterocolitis</mesh_term>
    <mesh_term>Enterocolitis, Neutropenic</mesh_term>
    <mesh_term>Graft vs Host Disease</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/NCT01699516
org study id: IRB33982
nct id: NCT01699516
lead sponsor: 
has dmc: No
Intestinal acute graft-vs-host disease (GVHD) is a life-threatening complication after
      allogeneic hematopoietic cell transplantation. Non-invasive diagnostic procedures are still
      lacking and diagnosis is difficult. We hypothesized that contrast-enhanced ultrasound
      sonography (CEUS) could detect microcirculation changes of the bowel walls during intestinal
      GVHD and help to detect and monitor treatment response. We employed CEUS to prospectively
      evaluate intestinal GVHD in 83 consecutive transplant patients between 2008 and 2011.
      Fourteen /83 patients with biopsy-proven intestinal GVHD were selected as study group.
      Fourteen patients with biopsy-proven stomach GVHD without intestinal symptoms (N=16), normal
      volunteers (N=6) and patients with neutropenic enterocolitis (N=4), were chosen as control
      group. All patients were evaluated with both standard transabdominal ultrasonography (US) and
      CEUS at the onset of intestinal symptoms, during clinical follow up and at flare of symptoms.
      Standard US revealed non-specific bowel wall thickening, and simultaneous involvement of
      multiple intestinal segments in 9/14 patients. CEUS showed three distinct patterns of
      microcirculation changes that correlated with GVHD activity. These findings were not observed
      in the control group. Moreover, CEUS findings correlated with treatment response and
      predicted flare of intestinal symptoms. CEUS is a non-invasive, easily reproducible bed-side
      tool to detect and monitor intestinal GVHD.
observational model: Case-Control
time perspective: Prospective
arm group label: Intestinal graft vs host disease
description: Patients with biopsy-proven intestinal acute GVHD in the setting of an allogenic transplant
arm group label: Control group
description: In the setting of an allogenic bone marrow transplant: patients with biopsy-proven stomach GVHD without intestinal symptoms and patients with neutropenic enterocolitis. Normal volunteers.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 22 Years
maximum age: 66 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Edoardo Benedetti, MD
phone: +39050993
phone ext: 085
email: edobenedetti@gmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: University of Pisa
investigator full name: Dr Edoardo Benedetti
investigator title: MD
mesh term: Enterocolitis
mesh term: Enterocolitis, Neutropenic
mesh term: Graft vs Host Disease