<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/NCT02241564</url>
  </required_header>
  <id_info>
    <org_study_id>MALTX-001</org_study_id>
    <nct_id>NCT02241564</nct_id>
  </id_info>
  <brief_title>Malignancies in Transplanted Patients</brief_title>
  <acronym>MALTX</acronym>
  <official_title>Follow-up of Malignancies in Transplanted Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Uppsala University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Uppsala University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the project is to improve the overall treatment and outcome of renal, pancreas or&#xD;
      liver transplanted patients who have encountered a malignancy by a structured treatment&#xD;
      program for diagnosis and treatment of the malignancy, optimization of the immunosuppressive&#xD;
      treatment, follow-up and evaluation of the program.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2007</start_date>
  <completion_date type="Actual">June 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient survival</measure>
    <time_frame>12 months, 2 years, 3 years</time_frame>
    <description>After inclusion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Graft survival</measure>
    <time_frame>12 months, 2 years, 3 years</time_frame>
    <description>After inclusion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ImmuKnow Assay value</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tumour progression/regression/reoccurrence</measure>
    <time_frame>12 months, 2 years, 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maintained switch of immunosuppression from calcineurin inhibitor to mTOR inhibitor</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Kidney function</measure>
    <time_frame>12 months, 2 years, 3 years</time_frame>
    <description>Creatinine measure</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">95</enrollment>
  <condition>Neoplasms</condition>
  <arm_group>
    <arm_group_label>Malignancy post transplantation</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Referral to a multidisciplinary expert panel at the Uppsala University Hospital after tumor detection</intervention_name>
    <arm_group_label>Malignancy post transplantation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Switch from calcineurin inhibitor to an mTOR inhibitor</intervention_name>
    <arm_group_label>Malignancy post transplantation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Kidney, pancreas or liver transplanted patients in the Uppsala/Örebro region with a&#xD;
        diagnosed malignancy pre or post transplantation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients willing and capable of giving written informed consent of participation in&#xD;
             the project&#xD;
&#xD;
          -  Patients with a previous diagnosed or presently diagnosed or reoccurrence of a&#xD;
             malignancy (other then basal cell carcinoma)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a primary liver cancer as cause of the transplantation&#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>Department of Surgery, Section of Transplantation Surgery, Uppsala University Hospital</name>
      <address>
        <city>Uppsala</city>
        <zip>SE-75185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <reference>
    <citation>Hellstrom V, Lorant T, Dohler B, Tufveson G, Enblad G. High Posttransplant Cancer Incidence in Renal Transplanted Patients With Pretransplant Cancer. Transplantation. 2017 Jun;101(6):1295-1302. doi: 10.1097/TP.0000000000001225.</citation>
    <PMID>27163539</PMID>
  </reference>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>September 11, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>October 24, 2017</last_update_submitted>
  <last_update_submitted_qc>October 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Uppsala University</investigator_affiliation>
    <investigator_full_name>Tomas Lorant</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>Immunosuppression</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sirolimus</mesh_term>
    <mesh_term>MTOR Inhibitors</mesh_term>
    <mesh_term>Temsirolimus</mesh_term>
    <mesh_term>Calcineurin Inhibitors</mesh_term>
  </intervention_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/NCT02241564
org study id: MALTX-001
nct id: NCT02241564
lead sponsor: 
has dmc: No
The aim of the project is to improve the overall treatment and outcome of renal, pancreas or
      liver transplanted patients who have encountered a malignancy by a structured treatment
      program for diagnosis and treatment of the malignancy, optimization of the immunosuppressive
      treatment, follow-up and evaluation of the program.
observational model: Case-Only
time perspective: Prospective
measure: Patient survival
time frame: 12 months, 2 years, 3 years
description: After inclusion
measure: Graft survival
time frame: 12 months, 2 years, 3 years
description: After inclusion
measure: ImmuKnow Assay value
time frame: 12 months
measure: Tumour progression/regression/reoccurrence
time frame: 12 months, 2 years, 3 years
measure: Maintained switch of immunosuppression from calcineurin inhibitor to mTOR inhibitor
time frame: 3 years
measure: Kidney function
time frame: 12 months, 2 years, 3 years
description: Creatinine measure
arm group label: Malignancy post transplantation
intervention type: Other
intervention name: Referral to a multidisciplinary expert panel at the Uppsala University Hospital after tumor detection
arm group label: Malignancy post transplantation
intervention type: Drug
intervention name: Switch from calcineurin inhibitor to an mTOR inhibitor
arm group label: Malignancy post transplantation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Sweden
citation: Hellstrom V, Lorant T, Dohler B, Tufveson G, Enblad G. High Posttransplant Cancer Incidence in Renal Transplanted Patients With Pretransplant Cancer. Transplantation. 2017 Jun;101(6):1295-1302. doi: 10.1097/TP.0000000000001225.
PMID: 27163539
responsible party type: Principal Investigator
investigator affiliation: Uppsala University
investigator full name: Tomas Lorant
investigator title: Associate professor
mesh term: Neoplasms
mesh term: Sirolimus
mesh term: MTOR Inhibitors
mesh term: Temsirolimus
mesh term: Calcineurin Inhibitors