<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/NCT03831620</url>
  </required_header>
  <id_info>
    <org_study_id>2018-02218</org_study_id>
    <nct_id>NCT03831620</nct_id>
  </id_info>
  <brief_title>The Crosstalk Between Calcium-sensing Receptor Signaling and Endocannabinoid System in Primary Hyperparathyroidism</brief_title>
  <acronym>Targeting CaSR</acronym>
  <official_title>The Crosstalk Between Calcium-sensing Receptor Signaling and Endocannabinoid System in Primary Hyperparathyroidism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Insel Gruppe AG, University Hospital Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Insel Gruppe AG, University Hospital Bern</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>
      Despite the strong association of hyperparathyroidism with arachidonic acid related lipid&#xD;
      signals, little research has been performed over the years. A better understanding of the&#xD;
      link between arachidonic acid remodeling, prostaglandin and endocannabinoid production with&#xD;
      primary hyperparathyroidism in primary tissue/cells might open up new avenues for biomarker&#xD;
      and thus to a potential therapeutic target.&#xD;
&#xD;
      Arachidonic acid remodeling might also have an impact on depression and elevated cytokines in&#xD;
      patients with primary hyperparathyroidism. The investigators therefore will assess the&#xD;
      correlation between postoperative improvement of PHQ-9 and cytokine levels with arachidonic&#xD;
      acid remodeling.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Actual">July 31, 2022</completion_date>
  <primary_completion_date type="Actual">July 31, 2022</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>2 Months</target_duration>
  <primary_outcome>
    <measure>Activity-based protein profiling (ABPP) will be used to assess the enzymes involved in calcium induced stress signals and endocannabinoid activation</measure>
    <time_frame>2 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurement of the level of parathyroid hormone</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of the level of calcium</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of the level of cortisol</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of the level of 25-hydroxyvitamin D</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of the levels of the enzymes involved in the endocannabinoid system activation (diacylglycerol lipase; monoacylglycerol lipase, phospholipases, cyclooxygenases)</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of the level of endocannabinoids, arachidonic acid species, prostanoids and related anti-inflammatory lipids</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of the level of IL-6 and TNF-α</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of Patient Health Questionnaire - 9</measure>
    <time_frame>2 months</time_frame>
    <description>The Patient Health Questionnaire (PHQ-9) is described as a valid depression scale with good sensitivity and specificity for detecting depressive disorders, ranging from 1 to 27.&#xD;
Depression severity:&#xD;
1 to 4: minimal; 5 to 9: mild; 10 to 14: moderate; 15 to 19: moderately severe; 20 to 27: severe</description>
  </secondary_outcome>
  <enrollment type="Actual">90</enrollment>
  <condition>Primary Hyperparathyroidism</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Primary hyperparathyroidism with planned surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years&#xD;
&#xD;
          -  Primary hyperparathyroidism with planned surgery&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
&#xD;
          -  Secondary/tertiary hyperparathyroidism&#xD;
&#xD;
          -  Renal insufficiency&#xD;
&#xD;
          -  Participant is pregnant&#xD;
&#xD;
          -  Participant is incapable of giving an informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Reto Kaderli, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Insel Gruppe AG, University Hospital Bern</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of visceral surgery and transplant surgery, Berne University Hospital</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>January 24, 2023</last_update_submitted>
  <last_update_submitted_qc>January 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2023</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>Hyperparathyroidism</mesh_term>
    <mesh_term>Hyperparathyroidism, Primary</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/NCT03831620
org study id: 2018-02218
nct id: NCT03831620
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Despite the strong association of hyperparathyroidism with arachidonic acid related lipid
      signals, little research has been performed over the years. A better understanding of the
      link between arachidonic acid remodeling, prostaglandin and endocannabinoid production with
      primary hyperparathyroidism in primary tissue/cells might open up new avenues for biomarker
      and thus to a potential therapeutic target.

      Arachidonic acid remodeling might also have an impact on depression and elevated cytokines in
      patients with primary hyperparathyroidism. The investigators therefore will assess the
      correlation between postoperative improvement of PHQ-9 and cytokine levels with arachidonic
      acid remodeling.
observational model: Cohort
time perspective: Prospective
measure: Activity-based protein profiling (ABPP) will be used to assess the enzymes involved in calcium induced stress signals and endocannabinoid activation
time frame: 2 months
measure: Measurement of the level of parathyroid hormone
time frame: 2 months
measure: Measurement of the level of calcium
time frame: 2 months
measure: Measurement of the level of cortisol
time frame: 2 months
measure: Measurement of the level of 25-hydroxyvitamin D
time frame: 2 months
measure: Measurement of the levels of the enzymes involved in the endocannabinoid system activation (diacylglycerol lipase; monoacylglycerol lipase, phospholipases, cyclooxygenases)
time frame: 2 months
measure: Measurement of the level of endocannabinoids, arachidonic acid species, prostanoids and related anti-inflammatory lipids
time frame: 2 months
measure: Measurement of the level of IL-6 and TNF-α
time frame: 2 months
measure: Assessment of Patient Health Questionnaire - 9
time frame: 2 months
description: The Patient Health Questionnaire (PHQ-9) is described as a valid depression scale with good sensitivity and specificity for detecting depressive disorders, ranging from 1 to 27.
Depression severity:
1 to 4: minimal; 5 to 9: mild; 10 to 14: moderate; 15 to 19: moderately severe; 20 to 27: severe
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Reto Kaderli, MD
role: Principal Investigator
affiliation: Insel Gruppe AG, University Hospital Bern
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Hyperparathyroidism
mesh term: Hyperparathyroidism, Primary