<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/NCT02983643</url>
  </required_header>
  <id_info>
    <org_study_id>IM.J-EC.04</org_study_id>
    <nct_id>NCT02983643</nct_id>
  </id_info>
  <brief_title>Body Composition Changes During Stem Cell Transplantation: The Case Of Lymphoma Patients</brief_title>
  <official_title>Body Composition Changes During Stem Cell Transplantation: The Case Of Lymphoma Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>American University of Beirut Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aix Marseille Université</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>American University of Beirut Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Skeletal Muscle Index (SMI) and Visceral Adipose Ratio (VAR) assess body composition changes&#xD;
      and disclose malnutrition risk effectively. The aims of the study are to assess prevalence of&#xD;
      malnutrition in patients planned for SCT, to characterize changes in body composition (SMI,&#xD;
      total adipose tissue and VAR) that occur in the peri transplantation phase, and to identify&#xD;
      Waist Circumference (WC) cut off points associated with the metabolic syndrome (MetSyn) in&#xD;
      patients with B and T cell Lymphoma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a retrospective cohort study of patients having B and T cell lymphoma, who&#xD;
      underwent SCT in the Bone Marrow Transplantation (BMT) unit at AUBMC. Consecutive patients&#xD;
      having B and T lymphoma who underwent SCT at AUBMC will be identified by the research team&#xD;
      and will be included as per the below inclusion and exclusion criteria. Starting from June&#xD;
      2016, patients who meet the inclusion criteria will be included in the study up until June&#xD;
      2006.&#xD;
&#xD;
      The radiologist will access the AUBMC PACS system to review PET/CT scans of the identified&#xD;
      patients. SMI, visceral, subcutaneous and intramuscular adipose tissues will be established&#xD;
      by assessing at the level of L3.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Anticipated">February 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sarcopenia Prevalence</measure>
    <time_frame>3 months post Stem Cell Transplantation</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Skeletal Muscle Index Changes</measure>
    <time_frame>3 months post Stem Cell Transplantation</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">105</enrollment>
  <condition>Hematopoietic Stem Cell Transplantation</condition>
  <condition>Malnutrition</condition>
  <condition>Metabolic Syndrome</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Consecutive patients having B and T lymphoma who underwent SCT between January 2006 and&#xD;
        June 2016 at AUBMC are identified by the research team and are included as per the below&#xD;
        inclusion and exclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age&gt;16 years&#xD;
&#xD;
          -  Patients having B and T cell lymphoma who have undergone SCT at AUBMC&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a missing pre-SCT PET/ CT scan&#xD;
&#xD;
          -  Patients with 2 missing post SCT PET / CT scan&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean El Cheikh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AUBMC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jean El Cheikh, MD</last_name>
    <phone>9611350000</phone>
    <phone_ext>7811</phone_ext>
    <email>je46@aub.edu.lb</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jana Jabbour, LD, MPH</last_name>
    <phone>9611759668</phone>
    <email>jj13@aub.edu.lb</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>American University of Beirut Medical Center</name>
      <address>
        <city>Beirut</city>
        <country>Lebanon</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jana Jabbour, LD, MPH</last_name>
      <phone>+961759668</phone>
      <email>jj13@aub.edu.lb</email>
    </contact>
    <contact_backup>
      <last_name>Jean El Cheikh, MD</last_name>
      <phone>+961350000</phone>
      <phone_ext>7811</phone_ext>
      <email>je46@aub.edu.lb</email>
    </contact_backup>
    <investigator>
      <last_name>Jean El Cheikh, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jana Jabbour, LD, MPH</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Batoul Manana, LD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Charbel Saadeh, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Ali Bazarbachi, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Didier Blaise, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Iman Abou Dalle, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Lebanon</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>October 3, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>May 9, 2017</last_update_submitted>
  <last_update_submitted_qc>May 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Skeletal Muscle Index</keyword>
  <keyword>Visceral Adipose Tissue</keyword>
  <keyword>Metabolic Syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Metabolic Syndrome</mesh_term>
    <mesh_term>Malnutrition</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</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/NCT02983643
org study id: IM.J-EC.04
nct id: NCT02983643
lead sponsor: 
collaborator: 
has dmc: No
Skeletal Muscle Index (SMI) and Visceral Adipose Ratio (VAR) assess body composition changes
      and disclose malnutrition risk effectively. The aims of the study are to assess prevalence of
      malnutrition in patients planned for SCT, to characterize changes in body composition (SMI,
      total adipose tissue and VAR) that occur in the peri transplantation phase, and to identify
      Waist Circumference (WC) cut off points associated with the metabolic syndrome (MetSyn) in
      patients with B and T cell Lymphoma.
This study is a retrospective cohort study of patients having B and T cell lymphoma, who
      underwent SCT in the Bone Marrow Transplantation (BMT) unit at AUBMC. Consecutive patients
      having B and T lymphoma who underwent SCT at AUBMC will be identified by the research team
      and will be included as per the below inclusion and exclusion criteria. Starting from June
      2016, patients who meet the inclusion criteria will be included in the study up until June
      2006.

      The radiologist will access the AUBMC PACS system to review PET/CT scans of the identified
      patients. SMI, visceral, subcutaneous and intramuscular adipose tissues will be established
      by assessing at the level of L3.
observational model: Cohort
time perspective: Retrospective
measure: Sarcopenia Prevalence
time frame: 3 months post Stem Cell Transplantation
measure: Skeletal Muscle Index Changes
time frame: 3 months post Stem Cell Transplantation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jean El Cheikh, MD
role: Principal Investigator
affiliation: AUBMC
last name: Jean El Cheikh, MD
phone: 9611350000
phone ext: 7811
email: je46@aub.edu.lb
last name: Jana Jabbour, LD, MPH
phone: 9611759668
email: jj13@aub.edu.lb
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Lebanon
responsible party type: Sponsor
mesh term: Metabolic Syndrome
mesh term: Malnutrition
sharing ipd: Yes