<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/NCT03832881</url>
  </required_header>
  <id_info>
    <org_study_id>08/0264</org_study_id>
    <nct_id>NCT03832881</nct_id>
  </id_info>
  <brief_title>The United Kingdom Thrombotic Thrombocytopenic Purpura Registry (UK TTP Registry)</brief_title>
  <official_title>The United Kingdom Thrombotic Thrombocytopenic Purpura Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University College, London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a UK (United Kingdom) based registry, involving all sites treating newly presenting&#xD;
      Thrombotic Thrombocytopenic Purpura (TTP). From this registry, important epidemiological data&#xD;
      will be obtained. Admission and remission samples will be collected. DNA will be collected&#xD;
      and analysed from patients wishing to participate to determine if any link exists between&#xD;
      mutations/polymorphisms and the risk of TTP. As part of NHS commissioning, we will be&#xD;
      undertaking long term follow up, to understand the impact of acute TTP on morbidity and&#xD;
      mortality.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The UK TTP registry started in January 2009, following 3 years MRC funding, involving UK&#xD;
      collaboration from all sites treating TTP patients. It has resulted in a cohort of data and&#xD;
      samples from UK TTP cases. The registry promotes a collaborative approach with all UK&#xD;
      patients and physicians involved with this life threatening disorder. The UK TTP registry has&#xD;
      been used to provide information for highly specialist commissioning via NHS England and&#xD;
      moving forward will be required to provide data relevant to the UK TTP Group and&#xD;
      commissioners.&#xD;
&#xD;
      University College London (UCL) Haemostasis Research Unit (HRU) will collect and collate the&#xD;
      data and help administrate for those sites participating in the registry. However, ADAMTS13&#xD;
      assays will no longer be subsidised. For those sites undertaking local assays, a record of&#xD;
      cases will be shared centrally. The UK TTP registry will be part of the UK TTP Group.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 2009</start_date>
  <completion_date type="Anticipated">November 2023</completion_date>
  <primary_completion_date type="Anticipated">November 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>TTP incidence</measure>
    <time_frame>At study completion, approximately in 2023</time_frame>
    <description>Number of TTP cases in the UK each year</description>
  </primary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>TTP - Thrombotic Thrombocytopenic Purpura</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>ADAMTS13, VWF assay</intervention_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      On Admission/Pre-treatment:&#xD;
&#xD;
      • A 5ml double spun citrate sample (platelet free plasma separated) taken on admission and/or&#xD;
      pre-treatment. (Part of Standard Care).&#xD;
&#xD;
      In Remission/Approximately 3 months post admission:&#xD;
&#xD;
        -  A 5ml double spun remission citrate sample (platelet free plasma separated) following&#xD;
           discharge from the acute episode. (Part of Standard Care)&#xD;
&#xD;
        -  A 5ml EDTA whole blood sample for DNA extraction. (Informed Consent from patient&#xD;
           required).&#xD;
&#xD;
        -  A 5ml serum sample. (Sample taken as part of Standard Care; Informed Consent required&#xD;
           for storage and use of sample for current and future analysis of parameters related to&#xD;
           TTP; Current tests include, IgG subtyping and Rituximab levels.)&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients presenting with an acute episode of Thrombotic Thrombocytopenic Purpura (TTP) will&#xD;
        be asked to consent for the registry once in remission. However, for those sites&#xD;
        undertaking ADAMTS13 analysis, consent for admission and remission samples for TTP cases&#xD;
        will be requested. A screening log of all cases analysed will be kept by sites and&#xD;
        forwarded at 3 monthly intervals. This will help identify other non-TTP causes for ADAMTS13&#xD;
        analysis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a clinical diagnosis of TTP, defined by thrombocytopenia, MAHA which may&#xD;
             be associated with clinical evidence of organ compromise.Confirmed by severely reduced&#xD;
             ADAMTS13 levels and/or a positive antibody screen.&#xD;
&#xD;
          -  No age restriction.&#xD;
&#xD;
          -  Consent for addition to the Registry and collection/storage of admission information&#xD;
             once in remission.&#xD;
&#xD;
          -  Consent to collect, analyse and store EDTA sample once in remission.&#xD;
&#xD;
          -  Consent to store samples once in remission (sample taken as part of standard care).&#xD;
&#xD;
          -  For sites undertaking ADAMTS13 analysis, consent to send admission and remission&#xD;
             samples for analysis relating to TTP.&#xD;
&#xD;
          -  Follow up laboratory and clinical data at least yearly to identify any changes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with cancer or transplant associated MAHA will not be included.&#xD;
&#xD;
          -  Patients not wishing to be involved with the registry.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>I Obu</last_name>
    <phone>0207 679 6428</phone>
    <email>uclh.ttp@nhs.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>University College London Hospital</name>
      <address>
        <city>London</city>
        <zip>NW1 2PG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Prof Marie Scully</last_name>
      <phone>0207 679 6428</phone>
      <email>uclh.ttp@nhs.net</email>
    </contact>
    <contact_backup>
      <last_name>I Obu</last_name>
      <phone>0207 679 6428</phone>
      <email>uclh.ttp@nhs.net</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 11, 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>February 5, 2019</last_update_submitted>
  <last_update_submitted_qc>February 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Purpura</mesh_term>
    <mesh_term>Purpura, Thrombocytopenic</mesh_term>
    <mesh_term>Purpura, Thrombotic Thrombocytopenic</mesh_term>
  </condition_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/NCT03832881
org study id: 08/0264
nct id: NCT03832881
lead sponsor: 
has dmc: No
This is a UK (United Kingdom) based registry, involving all sites treating newly presenting
      Thrombotic Thrombocytopenic Purpura (TTP). From this registry, important epidemiological data
      will be obtained. Admission and remission samples will be collected. DNA will be collected
      and analysed from patients wishing to participate to determine if any link exists between
      mutations/polymorphisms and the risk of TTP. As part of NHS commissioning, we will be
      undertaking long term follow up, to understand the impact of acute TTP on morbidity and
      mortality.
The UK TTP registry started in January 2009, following 3 years MRC funding, involving UK
      collaboration from all sites treating TTP patients. It has resulted in a cohort of data and
      samples from UK TTP cases. The registry promotes a collaborative approach with all UK
      patients and physicians involved with this life threatening disorder. The UK TTP registry has
      been used to provide information for highly specialist commissioning via NHS England and
      moving forward will be required to provide data relevant to the UK TTP Group and
      commissioners.

      University College London (UCL) Haemostasis Research Unit (HRU) will collect and collate the
      data and help administrate for those sites participating in the registry. However, ADAMTS13
      assays will no longer be subsidised. For those sites undertaking local assays, a record of
      cases will be shared centrally. The UK TTP registry will be part of the UK TTP Group.
observational model: Other
time perspective: Other
measure: TTP incidence
time frame: At study completion, approximately in 2023
description: Number of TTP cases in the UK each year
intervention type: Diagnostic Test
intervention name: ADAMTS13, VWF assay
On Admission/Pre-treatment:

      • A 5ml double spun citrate sample (platelet free plasma separated) taken on admission and/or
      pre-treatment. (Part of Standard Care).

      In Remission/Approximately 3 months post admission:

        -  A 5ml double spun remission citrate sample (platelet free plasma separated) following
           discharge from the acute episode. (Part of Standard Care)

        -  A 5ml EDTA whole blood sample for DNA extraction. (Informed Consent from patient
           required).

        -  A 5ml serum sample. (Sample taken as part of Standard Care; Informed Consent required
           for storage and use of sample for current and future analysis of parameters related to
           TTP; Current tests include, IgG subtyping and Rituximab levels.)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: I Obu
phone: 0207 679 6428
email: uclh.ttp@nhs.net
facility: 
status: Recruiting
contact: 
contact backup: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Purpura
mesh term: Purpura, Thrombocytopenic
mesh term: Purpura, Thrombotic Thrombocytopenic