<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/NCT03833050</url>
  </required_header>
  <id_info>
    <org_study_id>17-000682</org_study_id>
    <nct_id>NCT03833050</nct_id>
  </id_info>
  <brief_title>The TOGETHER Project - Heart</brief_title>
  <acronym>TOGETHER</acronym>
  <official_title>The TOGETHER Project - Transplant Organ Genomics to Help Prevent Rejection in Heart Transplant Recipients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</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 researchers are trying to develop a way to measure the risk of transplant rejection with&#xD;
      a blood test.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study will utilize peripheral blood assays collected at time points that are considered&#xD;
      standard of care at most institutions. Subjects will have peripheral blood collected at 1&#xD;
      month, 3 months, 6 months, and 12 months after heart transplantation, as well as any for&#xD;
      cause time points. These samples will then be used for purposes of developing an RNA-seq&#xD;
      based peripheral blood assay in adult heart transplant recipients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 7, 2017</start_date>
  <completion_date type="Actual">September 22, 2020</completion_date>
  <primary_completion_date type="Actual">September 22, 2020</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>RNA-seq based peripheral blood assay in heart transplant recipients</measure>
    <time_frame>3 years</time_frame>
    <description>Cases will be reviewed and a subset of the peripheral blood specimens will be sent to Mayo Clinic Laboratories for development of the RNA-seq signature. The number of specimens analyzed will be determined based on the incidence of rejection and the incidence of biopsies for cause needed to develop the signature.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">101</enrollment>
  <condition>Heart Transplant Rejection</condition>
  <arm_group>
    <arm_group_label>Heart Transplant Recipients</arm_group_label>
    <description>Heart Transplant Recipients meeting the criteria for enrollment and consented will be followed post transplant for 1 year after enrollment into the study.&#xD;
Blood samples will be obtained at their 1, 3, 6, 12 months and any for cause heart biopsy's obtained. There will be no active intervention for recipients that are enrolled. Results from the samples will not be obtained in real time.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      15 ml peripheral Blood samples will be processed for DNA extraction and plasma for RNA seq&#xD;
      isolation peripheral blood assay will be obtained at 1, 3, 6, 12 months and for cause.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Heart Transplant recipients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients who meet all of the following criteria are eligible for enrollment as study&#xD;
        participants:&#xD;
&#xD;
          -  Adult (≥18 years) solitary heart transplant recipient&#xD;
&#xD;
          -  Patient is willing and able to provide informed written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients who meet any of these criteria are not eligible for enrollment as study&#xD;
        participants:&#xD;
&#xD;
          -  Adult (&lt;18 years) heart transplant recipient&#xD;
&#xD;
          -  Patient refusal to enroll in the studyc3. Any simultaneous heart and extra organ&#xD;
             transplant, including pancreas, liver, lung, kidney, etc. Subjects who have had&#xD;
             previous transplants may be included.&#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>Naveen Pereira, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mark D Stegall, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</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>Mayo Clinic</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>559055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>June 10, 2022</last_update_submitted>
  <last_update_submitted_qc>June 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Naveen L. Pereira</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>heart transplant</keyword>
  <!-- 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/NCT03833050
org study id: 17-000682
nct id: NCT03833050
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The researchers are trying to develop a way to measure the risk of transplant rejection with
      a blood test.
The study will utilize peripheral blood assays collected at time points that are considered
      standard of care at most institutions. Subjects will have peripheral blood collected at 1
      month, 3 months, 6 months, and 12 months after heart transplantation, as well as any for
      cause time points. These samples will then be used for purposes of developing an RNA-seq
      based peripheral blood assay in adult heart transplant recipients.
observational model: Cohort
time perspective: Prospective
measure: RNA-seq based peripheral blood assay in heart transplant recipients
time frame: 3 years
description: Cases will be reviewed and a subset of the peripheral blood specimens will be sent to Mayo Clinic Laboratories for development of the RNA-seq signature. The number of specimens analyzed will be determined based on the incidence of rejection and the incidence of biopsies for cause needed to develop the signature.
arm group label: Heart Transplant Recipients
description: Heart Transplant Recipients meeting the criteria for enrollment and consented will be followed post transplant for 1 year after enrollment into the study.
Blood samples will be obtained at their 1, 3, 6, 12 months and any for cause heart biopsy's obtained. There will be no active intervention for recipients that are enrolled. Results from the samples will not be obtained in real time.
15 ml peripheral Blood samples will be processed for DNA extraction and plasma for RNA seq
      isolation peripheral blood assay will be obtained at 1, 3, 6, 12 months and for cause.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Naveen Pereira, M.D.
role: Principal Investigator
affiliation: Mayo Clinic
last name: Mark D Stegall, M.D.
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
facility: 
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Naveen L. Pereira
investigator title: Principal Investigator