<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/NCT01672164</url>
  </required_header>
  <id_info>
    <org_study_id>DAIT CTOT-14</org_study_id>
    <nct_id>NCT01672164</nct_id>
  </id_info>
  <brief_title>Discovery and Validation of Proteogenomic Biomarker Panels in Liver Transplant Recipients</brief_title>
  <acronym>PROGENI-LI</acronym>
  <official_title>Discovery and Validation of Proteogenomic Biomarker Panels in a Prospective Serial Blood and Urine Monitoring Study of Liver Transplant Recipients - Transplant Proteogenomics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Clinical Trials in Organ Transplantation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Institute of Allergy and Infectious Diseases (NIAID)</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main focus of this study is to develop blood and/or urine tests that will help to detect&#xD;
      early signs of rejection in people who have had a liver transplant. Researchers will examine&#xD;
      blood, urine, and tissue samples and try to identify markers for certain conditions such as&#xD;
      rejection, response to therapy, and scarring of the liver. Additionally, researchers would&#xD;
      like to identify biomarkers that can detect damage to the native kidneys before blood levels&#xD;
      of creatinine rises. By studying gene expression, researchers hope to be able to diagnose&#xD;
      these conditions earlier and improve liver survival.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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>Acute Rejection</measure>
    <time_frame>3 months after liver transplant</time_frame>
    <description>The primary endpoint is the incidence of biopsy proven AR at 3, 12 and 24 months after LT.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acute Rejection</measure>
    <time_frame>12 months after liver transplant</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Acute Rejection</measure>
    <time_frame>24 months after liver transplant</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Severity of acute rejection</measure>
    <time_frame>Baseline (Visit 1) to Month 24 (Visit 12):</time_frame>
    <description>Severity (initial grade, steroid-responsive vs. refractory by biopsy) and clinical/biochemical resolution following treatment of AR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recurrent Hepatitis-C Virus (HCV-R)</measure>
    <time_frame>Baseline (Visit 1) to Month 24 (Visit 12)</time_frame>
    <description>Incidence, severity (grade, stage), and treatment (requirement for, response rates) of HCV-R</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chronic Kidney Disease(CKD)</measure>
    <time_frame>Baseline (Visit 1) to Month 24 (Visit 12)</time_frame>
    <description>Incidence, severity (stage, need for renal replacement therapy or kidney transplantation), and response to treatment (CNI reduction/withdrawal ± MPA or mTOR) of CKD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of death, graft loss, and need for liver retransplantation</measure>
    <time_frame>Baseline (Visit 1) to Month 24 (Visit 12)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of opportunistic infections, malignancy, and cardiovascular complications</measure>
    <time_frame>Baseline (Visit 1) to Month 24 (Visit 12)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mRNA expression profiles of peripheral blood (AR, HCV-R, CKD)</measure>
    <time_frame>Baseline (Visit 1) to Month 24 (Visit 12)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mRNA expression profiles of liver biopsies (AR, HCV-R)</measure>
    <time_frame>Baseline (Visit 1) to Month 24 (Visit 12)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Protein expression profiles of plasma ( AR, HCV-R, CKD)</measure>
    <time_frame>Baseline (Visit 1) to Month 24 (Visit 12)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Protein expression profiles of urine (CKD)</measure>
    <time_frame>Baseline (Visit 1) to Month 24 (visit 12)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>microRNA Profiling Plasma &amp; Cells</measure>
    <time_frame>Baseline (Visit 1) to Month 24 (Visit 12)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multiparameter Flow Cytometry - Viral Pathogens</measure>
    <time_frame>Baseline (Visit 1) to Month 24 (Visit 12)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Viral Monitoring - EBV &amp; CMV</measure>
    <time_frame>Baseline (Visit 1) to Month 24 (Visit 12)</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">202</enrollment>
  <condition>Liver Transplant Recipients</condition>
  <condition>Liver Transplantation</condition>
  <arm_group>
    <arm_group_label>Liver Transplant Recipients</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      whole blood, plasma, serum, urine supernatant, urine pellet and tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Liver Transplant Recipients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects undergoing primary deceased-donor or living donor liver transplantation;&#xD;
&#xD;
          -  Subject must be able to understand and provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Need for combined organ transplantation;&#xD;
&#xD;
          -  Previous solid organ and/or islet cell transplantation;&#xD;
&#xD;
          -  Infection with HIV;&#xD;
&#xD;
          -  Allergy to iodine;&#xD;
&#xD;
          -  Inability or unwillingness of a participant to comply with study protocol;&#xD;
&#xD;
          -  Any condition that, in the opinion of the investigator, would interfere with the&#xD;
             participant's ability to comply with study requirements.&#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>Josh Levitsky, MD, MS</last_name>
    <role>Study Chair</role>
    <affiliation>Northwestern University Feinberg School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michael Abecassis, MD, MBA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwestern University Feinberg School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University, Feinberg School of Medicine</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai School of Medicine</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44295</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor University Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75246</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.niaid.nih.gov</url>
    <description>National Institute of Allergy and Infectious Diseases (NIAID)</description>
  </link>
  <link>
    <url>http://www.ctotstudies.org/</url>
    <description>Clinical Trials in Organ Transplantation (CTOT)</description>
  </link>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>September 1, 2016</last_update_submitted>
  <last_update_submitted_qc>September 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>proteogenomic biomarker panels</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The plan is to share data in ImmPort, a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts that also provides data analysis tools that are available to researchers who register online and subsequently receive DAIT approval.</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/NCT01672164
org study id: DAIT CTOT-14
nct id: NCT01672164
lead sponsor: 
collaborator: 
has dmc: Yes
The main focus of this study is to develop blood and/or urine tests that will help to detect
      early signs of rejection in people who have had a liver transplant. Researchers will examine
      blood, urine, and tissue samples and try to identify markers for certain conditions such as
      rejection, response to therapy, and scarring of the liver. Additionally, researchers would
      like to identify biomarkers that can detect damage to the native kidneys before blood levels
      of creatinine rises. By studying gene expression, researchers hope to be able to diagnose
      these conditions earlier and improve liver survival.
observational model: Cohort
time perspective: Prospective
measure: Acute Rejection
time frame: 3 months after liver transplant
description: The primary endpoint is the incidence of biopsy proven AR at 3, 12 and 24 months after LT.
measure: Acute Rejection
time frame: 12 months after liver transplant
measure: Acute Rejection
time frame: 24 months after liver transplant
measure: Severity of acute rejection
time frame: Baseline (Visit 1) to Month 24 (Visit 12):
description: Severity (initial grade, steroid-responsive vs. refractory by biopsy) and clinical/biochemical resolution following treatment of AR
measure: Recurrent Hepatitis-C Virus (HCV-R)
time frame: Baseline (Visit 1) to Month 24 (Visit 12)
description: Incidence, severity (grade, stage), and treatment (requirement for, response rates) of HCV-R
measure: Chronic Kidney Disease(CKD)
time frame: Baseline (Visit 1) to Month 24 (Visit 12)
description: Incidence, severity (stage, need for renal replacement therapy or kidney transplantation), and response to treatment (CNI reduction/withdrawal ± MPA or mTOR) of CKD
measure: Incidence of death, graft loss, and need for liver retransplantation
time frame: Baseline (Visit 1) to Month 24 (Visit 12)
measure: Incidence of opportunistic infections, malignancy, and cardiovascular complications
time frame: Baseline (Visit 1) to Month 24 (Visit 12)
measure: mRNA expression profiles of peripheral blood (AR, HCV-R, CKD)
time frame: Baseline (Visit 1) to Month 24 (Visit 12)
measure: mRNA expression profiles of liver biopsies (AR, HCV-R)
time frame: Baseline (Visit 1) to Month 24 (Visit 12)
measure: Protein expression profiles of plasma ( AR, HCV-R, CKD)
time frame: Baseline (Visit 1) to Month 24 (Visit 12)
measure: Protein expression profiles of urine (CKD)
time frame: Baseline (Visit 1) to Month 24 (visit 12)
measure: microRNA Profiling Plasma & Cells
time frame: Baseline (Visit 1) to Month 24 (Visit 12)
measure: Multiparameter Flow Cytometry - Viral Pathogens
time frame: Baseline (Visit 1) to Month 24 (Visit 12)
measure: Viral Monitoring - EBV & CMV
time frame: Baseline (Visit 1) to Month 24 (Visit 12)
arm group label: Liver Transplant Recipients
whole blood, plasma, serum, urine supernatant, urine pellet and tissue
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Josh Levitsky, MD, MS
role: Study Chair
affiliation: Northwestern University Feinberg School of Medicine
last name: Michael Abecassis, MD, MBA
role: Principal Investigator
affiliation: Northwestern University Feinberg School of Medicine
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.niaid.nih.gov
description: National Institute of Allergy and Infectious Diseases (NIAID)
url: http://www.ctotstudies.org/
description: Clinical Trials in Organ Transplantation (CTOT)
responsible party type: Sponsor
sharing ipd: Yes
ipd description: The plan is to share data in ImmPort, a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts that also provides data analysis tools that are available to researchers who register online and subsequently receive DAIT approval.