<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/NCT03259282</url>
  </required_header>
  <id_info>
    <org_study_id>35RC16_3046_GAMES</org_study_id>
    <nct_id>NCT03259282</nct_id>
  </id_info>
  <brief_title>Gammaglobulins Level is Predictive Factor of Evolution in Sarcoidosis</brief_title>
  <acronym>GAMES</acronym>
  <official_title>Gammaglobulins Level is Predictive Factor of Evolution in Sarcoidosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</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>
      Evaluation of the rate of achievement of serum protein electrophoresis (PPE) in diagnosis in&#xD;
      a retrospective cohort of patients at Rennes University Hospital&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In 50% of cases, sarcoidosis is associated with polyclonal hypergammaglobulinemia. The other&#xD;
      forms have a normal gamma globulin level.&#xD;
&#xD;
      The level of gamma globulinemia has not yet been studied as an evolutionary predictive&#xD;
      factor. Furthermore, there are disseminated granulomatoses sharing common characteristics&#xD;
      with sarcoidosis, associated with Common Variable Immunodeficiency deficit (DICV) type&#xD;
      Primary Immunodeficiency syndrome (DIP), thus occurring in hypogammaglobulinemic patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 7, 2017</start_date>
  <completion_date type="Actual">March 22, 2017</completion_date>
  <primary_completion_date type="Actual">March 22, 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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Study of gamma globulin level present in the blood at the time of diagnosis of sarcoidosis on disease activity</measure>
    <time_frame>Day 1</time_frame>
    <description>Electrophoresis rates of serum proteins</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Study of gamma globulin level present in the blood at the time of diagnosis of sarcoidosis on the course of the disease</measure>
    <time_frame>Day 1</time_frame>
    <description>Electrophoresis rates of serum proteins</description>
  </primary_outcome>
  <enrollment type="Actual">78</enrollment>
  <condition>Sarcoidosis</condition>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Analysis of gamma globulin</intervention_name>
    <description>Electrophoresis of proteins</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with sarcoidosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Patients newly diagnosed with sarcoidosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Comorbidity responsible for a change in the level of gamma globulin&#xD;
&#xD;
          -  Other etiology of granulomatosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU de Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>April 10, 2018</last_update_submitted>
  <last_update_submitted_qc>April 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2018</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>Sarcoidosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>gamma-Globulins</mesh_term>
    <mesh_term>Immunoglobulins, Intravenous</mesh_term>
    <mesh_term>Rho(D) Immune Globulin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03259282
org study id: 35RC16_3046_GAMES
nct id: NCT03259282
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Evaluation of the rate of achievement of serum protein electrophoresis (PPE) in diagnosis in
      a retrospective cohort of patients at Rennes University Hospital
In 50% of cases, sarcoidosis is associated with polyclonal hypergammaglobulinemia. The other
      forms have a normal gamma globulin level.

      The level of gamma globulinemia has not yet been studied as an evolutionary predictive
      factor. Furthermore, there are disseminated granulomatoses sharing common characteristics
      with sarcoidosis, associated with Common Variable Immunodeficiency deficit (DICV) type
      Primary Immunodeficiency syndrome (DIP), thus occurring in hypogammaglobulinemic patients.
observational model: Case-Only
time perspective: Retrospective
measure: Study of gamma globulin level present in the blood at the time of diagnosis of sarcoidosis on disease activity
time frame: Day 1
description: Electrophoresis rates of serum proteins
measure: Study of gamma globulin level present in the blood at the time of diagnosis of sarcoidosis on the course of the disease
time frame: Day 1
description: Electrophoresis rates of serum proteins
intervention type: Biological
intervention name: Analysis of gamma globulin
description: Electrophoresis of proteins
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Sarcoidosis
mesh term: gamma-Globulins
mesh term: Immunoglobulins, Intravenous
mesh term: Rho(D) Immune Globulin
sharing ipd: No