<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/NCT03297892</url>
  </required_header>
  <id_info>
    <org_study_id>CUSHING RB (15.217)</org_study_id>
    <nct_id>NCT03297892</nct_id>
  </id_info>
  <brief_title>Health Status of the Patients Followed for a Disease of Cushing in the Region Large-West of 1990 to 2015</brief_title>
  <acronym>CUSHING</acronym>
  <official_title>Etat de santé Des Patients Suivis Pour Une Maladie de Cushing Dans la région Grand-Ouest de 1990 à 2015</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cushing's disease is a rare disease that can reduce patients' expectations or quality of&#xD;
      life, and for which predictive factors for cardiovascular mortality and recurrence are not&#xD;
      well defined.&#xD;
&#xD;
      The primary objective is to determine the rates of remission and recurrence of patients with&#xD;
      Cushing's disease diagnosed between 1990 and 2015 in the French region of the West (Angers,&#xD;
      Brest, Nantes, Rennes, Poitiers , Tours) focusing on remission particularly at two periods :&#xD;
      that after the first pituitary surgery and that on the day of the last news.&#xD;
&#xD;
      The secondary objective is to study the possible prediction of clinical and biological data&#xD;
      perioperative of remission and recurrence during follow-up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators are interested in the prevalence of complications of the pathology&#xD;
      (cardiovascular, metabolic, neuropsychological, infectious, rheumatological, etc.) within&#xD;
      this cohort, the mortality rate, the rate of remission and recurrence and the quality of life&#xD;
      history using the history of patient illness and a questionnaire.&#xD;
&#xD;
      All patients over the age of 18 years at the time of inclusion, formerly or currently being&#xD;
      monitored for Cushing's disease diagnosed between January 1, 1990 and December 31, 2015, in&#xD;
      one of the six university centers in the West part of France can be included.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 2017</start_date>
  <completion_date type="Anticipated">March 2018</completion_date>
  <primary_completion_date type="Anticipated">March 2018</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Rates de remission and recurrence after the first surgery</measure>
    <time_frame>between 1 January 1990 and 31 December 2015</time_frame>
    <description>rate of postoperative 3-month remission and rate of recurrence after the first surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>predictive factors of remission and recurrence</measure>
    <time_frame>between 1 January 1990 and 31 December 2015</time_frame>
    <description>To study the significance link between the peri-operative clinical and biological characteristics and remission on the one hand and the risk of recurrence after first pituitary surgery on the other hand.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Cushing Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients over the age of 18 at inclusion, formerly or currently being followed for&#xD;
        Cushing's disease diagnosed between 1 January 1990 and 31 December 2015 in one of the six&#xD;
        university centers in the French West.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients over the age of 18 at inclusion,&#xD;
&#xD;
          -  formerly or currently being followed for Cushing's disease diagnosed between 1 January&#xD;
             1990 and 31 December 2015 in one of the six university centers in the French West.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minor patients,&#xD;
&#xD;
          -  patients with a pathologic analysis in favor of a mixed secretion adenoma (positive&#xD;
             immunohistochemical analysis for ACTH and another hormone of the anterior pituitary).&#xD;
&#xD;
          -  patients who have undergone a pathologic diagnosis of &quot;adenoma to ACTH&quot; without&#xD;
             clinical-biological Cushing syndrome, ie silent adenoma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>October 3, 2017</last_update_submitted>
  <last_update_submitted_qc>October 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2017</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>ACTH-Secreting Pituitary Adenoma</mesh_term>
    <mesh_term>Pituitary ACTH Hypersecretion</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/NCT03297892
org study id: CUSHING RB (15.217)
nct id: NCT03297892
lead sponsor: 
has dmc: No
Cushing's disease is a rare disease that can reduce patients' expectations or quality of
      life, and for which predictive factors for cardiovascular mortality and recurrence are not
      well defined.

      The primary objective is to determine the rates of remission and recurrence of patients with
      Cushing's disease diagnosed between 1990 and 2015 in the French region of the West (Angers,
      Brest, Nantes, Rennes, Poitiers , Tours) focusing on remission particularly at two periods :
      that after the first pituitary surgery and that on the day of the last news.

      The secondary objective is to study the possible prediction of clinical and biological data
      perioperative of remission and recurrence during follow-up.
Investigators are interested in the prevalence of complications of the pathology
      (cardiovascular, metabolic, neuropsychological, infectious, rheumatological, etc.) within
      this cohort, the mortality rate, the rate of remission and recurrence and the quality of life
      history using the history of patient illness and a questionnaire.

      All patients over the age of 18 years at the time of inclusion, formerly or currently being
      monitored for Cushing's disease diagnosed between January 1, 1990 and December 31, 2015, in
      one of the six university centers in the West part of France can be included.
observational model: Cohort
time perspective: Prospective
measure: Rates de remission and recurrence after the first surgery
time frame: between 1 January 1990 and 31 December 2015
description: rate of postoperative 3-month remission and rate of recurrence after the first surgery
measure: predictive factors of remission and recurrence
time frame: between 1 January 1990 and 31 December 2015
description: To study the significance link between the peri-operative clinical and biological characteristics and remission on the one hand and the risk of recurrence after first pituitary surgery on the other hand.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: ACTH-Secreting Pituitary Adenoma
mesh term: Pituitary ACTH Hypersecretion