<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/NCT03272841</url>
  </required_header>
  <id_info>
    <org_study_id>TXLINES01</org_study_id>
    <nct_id>NCT03272841</nct_id>
  </id_info>
  <brief_title>TransplantLines: the Transplantation Biobank</brief_title>
  <official_title>TransplantLines: the Transplantation Biobank</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Center Groningen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medical Center Groningen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      TransplantLines is an observational cohort study in all solid transplant recipients, i.e.&#xD;
      kidney, heart, lung, liver, small bowel and pancreas. In this study we will gather&#xD;
      questionnaires about topics affecting transplant recipients, e.g. QoL, work and physical&#xD;
      capacity. Moreover, we will collect multiple urine and blood samples for analysis.&#xD;
      Additionally, we will store hair, nails and faeces from the transplant recipients. Next to&#xD;
      this, we will perform physical capacity tests and cognitive tests.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The last decades, the acute period after transplantation has markedly improved due to&#xD;
      improved tissue-matching techniques and better immunosuppressive drugs. However, nowadays the&#xD;
      major aim after transplantation is the long-term patient and graft survival which are still&#xD;
      poor, where half of the RTR looses their graft after 10 years. With TransplantLines we are&#xD;
      setting up an extensive biobank to improve the long-term survival after transplantation.&#xD;
      Moreover, we are one of the few studies to collect across transplant specialities. Like&#xD;
      mentioned in the brief summary, extensive questionnaires will be send to participants prior&#xD;
      to the visit containing multiple questionnaires (e.g. SF-36, WHODAS, PQ-SGA etc.). During the&#xD;
      visit, we will collect multiple blood samples who will be taken during the regularly visit to&#xD;
      the clinician. Moreover, two tubes from 24-hour urine collection will be collected, faeces,&#xD;
      hair and nails will be stored. Finally, physical tests and cognitive tests will be performed&#xD;
      with the participants (e.g. 2-min walking test, 4m walking test, timed-up-and-go test etc.).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>June 2015</start_date>
  <completion_date type="Anticipated">January 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2020</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>30 Years</target_duration>
  <primary_outcome>
    <measure>Graft failure / mortality</measure>
    <time_frame>Untill 2020</time_frame>
    <description>Development of graft failure or mortality in the transplant recipients</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">3000</enrollment>
  <condition>Solid Organ Tranplant Recipients, 18+ Years</condition>
  <arm_group>
    <arm_group_label>Transplant recipients</arm_group_label>
    <description>Renal, heart, lung, liver, small bowel, pancreas or combined transplant recipients</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      1x serum&#xD;
&#xD;
      1x EDTA&#xD;
&#xD;
      1x Lithium-heparine&#xD;
&#xD;
      1x Citrate&#xD;
&#xD;
      1x PAXgene Faeces, hair and nails&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All solid organ transplantation patients&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Solid organ transplant recipients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age younger than 18 years old&#xD;
&#xD;
          -  Cognitive dysfunction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Medical Center Groningen</name>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 2, 2017</study_first_submitted>
  <study_first_submitted_qc>September 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 2, 2017</last_update_submitted>
  <last_update_submitted_qc>September 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Center Groningen</investigator_affiliation>
    <investigator_full_name>Prof. dr. S.J.L. Bakker, MD, PhD</investigator_full_name>
    <investigator_title>Internist-nephrologist</investigator_title>
  </responsible_party>
  <!-- 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/NCT03272841
org study id: TXLINES01
nct id: NCT03272841
lead sponsor: 
has dmc: Yes
TransplantLines is an observational cohort study in all solid transplant recipients, i.e.
      kidney, heart, lung, liver, small bowel and pancreas. In this study we will gather
      questionnaires about topics affecting transplant recipients, e.g. QoL, work and physical
      capacity. Moreover, we will collect multiple urine and blood samples for analysis.
      Additionally, we will store hair, nails and faeces from the transplant recipients. Next to
      this, we will perform physical capacity tests and cognitive tests.
The last decades, the acute period after transplantation has markedly improved due to
      improved tissue-matching techniques and better immunosuppressive drugs. However, nowadays the
      major aim after transplantation is the long-term patient and graft survival which are still
      poor, where half of the RTR looses their graft after 10 years. With TransplantLines we are
      setting up an extensive biobank to improve the long-term survival after transplantation.
      Moreover, we are one of the few studies to collect across transplant specialities. Like
      mentioned in the brief summary, extensive questionnaires will be send to participants prior
      to the visit containing multiple questionnaires (e.g. SF-36, WHODAS, PQ-SGA etc.). During the
      visit, we will collect multiple blood samples who will be taken during the regularly visit to
      the clinician. Moreover, two tubes from 24-hour urine collection will be collected, faeces,
      hair and nails will be stored. Finally, physical tests and cognitive tests will be performed
      with the participants (e.g. 2-min walking test, 4m walking test, timed-up-and-go test etc.).
observational model: Cohort
time perspective: Prospective
measure: Graft failure / mortality
time frame: Untill 2020
description: Development of graft failure or mortality in the transplant recipients
arm group label: Transplant recipients
description: Renal, heart, lung, liver, small bowel, pancreas or combined transplant recipients
1x serum

      1x EDTA

      1x Lithium-heparine

      1x Citrate

      1x PAXgene Faeces, hair and nails
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: University Medical Center Groningen
investigator full name: Prof. dr. S.J.L. Bakker, MD, PhD
investigator title: Internist-nephrologist