<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/NCT03832140</url>
  </required_header>
  <id_info>
    <org_study_id>PRURIGAMMA (29BRC18.0192)</org_study_id>
    <nct_id>NCT03832140</nct_id>
  </id_info>
  <brief_title>Frequency and Characteristics of Pruritus in Patients With Monoclonal Gammopathy</brief_title>
  <acronym>PRURIGAMMA</acronym>
  <official_title>Frequency and Characteristics of Pruritus in Patients With Monoclonal Gammopathy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</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>
      Pruritus is most often secondary to dermatitis but can also occur without skin lesions, it is&#xD;
      called pruritus sine materia. The causes of pruritus sine materia are various: haematological&#xD;
      (myeloproliferative neoplasia ...), hepatic (cholestasis ...), renal (chronic renal failure,&#xD;
      dialysis), endocrine (iron deficiency ...), secondary to drug intake ... or idiopathic when&#xD;
      no cause is found.&#xD;
&#xD;
      Gammapathies are among the causes of pruritus sine materia, and as such electrophoresis of&#xD;
      serum proteins is usually part of the pruritus assessment to look for monoclonal gammopathy&#xD;
      (MGUS, multiple myeloma, Waldenström disease). However, there is very little data on the&#xD;
      frequency of pruritus in patients with monoclonal gammopathy and the characteristics of this&#xD;
      pruritus. So the aim of this study is to compare the frequency of pruritus between patients&#xD;
      with monoclonal gammapathy and controls&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 24, 2019</start_date>
  <completion_date type="Actual">November 19, 2019</completion_date>
  <primary_completion_date type="Actual">November 19, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Frequency of pruritus</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">281</enrollment>
  <condition>Pruritus</condition>
  <condition>Monoclonal Gammopathy</condition>
  <arm_group>
    <arm_group_label>Patients with monoclonal gammopathy</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>patients with a normal plasma protein electrophoresis</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who had serum protein electrophoresis at Brest CHRU between 2014 and 2017, with&#xD;
        and without gammapathy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for case :&#xD;
&#xD;
        Major patient Realized Serum protein electrophoresis between 2014 and 2017 Hematology&#xD;
        follow-up at Brest CHR Positive monoclonal gammopathy Non-opposition formulated&#xD;
&#xD;
        Inclusion Criteria for Control :&#xD;
&#xD;
        Major patient Realized Serum protein electrophoresis between 2014 and 2017 Hematology&#xD;
        follow-up at Brest CHR Negative gammopathy Non-opposition formulated&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Minor patient Major protected Patient with another haemopathy secreting a monoclonal&#xD;
        immunoglobulin (lymphoma, LLC ...) Physical or mental incapacity Refusal to participe&#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>CHRU de Brest</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2020</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>August 25, 2020</last_update_submitted>
  <last_update_submitted_qc>August 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2020</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>Paraproteinemias</mesh_term>
    <mesh_term>Monoclonal Gammopathy of Undetermined Significance</mesh_term>
    <mesh_term>Pruritus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>All collected data that underlie results in a publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Data will be available after the publication of result and ending three years maximum following the last visit of the last patient</ipd_time_frame>
    <ipd_access_criteria>Data access requests will be reviewed by the internal committee of Brest UH. requestors will be required to sign and complete a data access agreement</ipd_access_criteria>
  </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/NCT03832140
org study id: PRURIGAMMA (29BRC18.0192)
nct id: NCT03832140
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Pruritus is most often secondary to dermatitis but can also occur without skin lesions, it is
      called pruritus sine materia. The causes of pruritus sine materia are various: haematological
      (myeloproliferative neoplasia ...), hepatic (cholestasis ...), renal (chronic renal failure,
      dialysis), endocrine (iron deficiency ...), secondary to drug intake ... or idiopathic when
      no cause is found.

      Gammapathies are among the causes of pruritus sine materia, and as such electrophoresis of
      serum proteins is usually part of the pruritus assessment to look for monoclonal gammopathy
      (MGUS, multiple myeloma, Waldenström disease). However, there is very little data on the
      frequency of pruritus in patients with monoclonal gammopathy and the characteristics of this
      pruritus. So the aim of this study is to compare the frequency of pruritus between patients
      with monoclonal gammapathy and controls
observational model: Case-Control
time perspective: Prospective
measure: Frequency of pruritus
time frame: through study completion, an average of 1 year
arm group label: Patients with monoclonal gammopathy
arm group label: patients with a normal plasma protein electrophoresis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Paraproteinemias
mesh term: Monoclonal Gammopathy of Undetermined Significance
mesh term: Pruritus
sharing ipd: Yes
ipd description: All collected data that underlie results in a publication
ipd info type: Study Protocol
ipd time frame: Data will be available after the publication of result and ending three years maximum following the last visit of the last patient
ipd access criteria: Data access requests will be reviewed by the internal committee of Brest UH. requestors will be required to sign and complete a data access agreement