<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/NCT03011736</url>
  </required_header>
  <id_info>
    <org_study_id>I 274915</org_study_id>
    <secondary_id>NCI-2016-01974</secondary_id>
    <secondary_id>I 274915</secondary_id>
    <nct_id>NCT03011736</nct_id>
  </id_info>
  <brief_title>Omission of Intact Parathyroid Hormone Testing During Surgery in Treating Patients With Primary Hyperparathyroidism</brief_title>
  <official_title>Single-Arm, Non-inferiority Study of Omission of Intraoperative Intact Parathyroid Hormone (PTH) During Minimally Invasive Parathyroidectomy for Primary Hyperparathyroidism</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Roswell Park Cancer Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Roswell Park Cancer Institute</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This clinical trial studies the omission of intact parathyroid hormone testing during surgery&#xD;
      in treating patients with primary hyperparathyroidism. Omission of intact parathyroid hormone&#xD;
      testing during parathyroid gland removal may help patients with primary hyperparathyroidism&#xD;
      to decrease their time under anesthesia, and decrease the overall time and cost of surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. Determine the non-inferiority of omission of parathyroid hormone (PTH) in patients who&#xD;
      meet the biochemical and radiological criteria compared to current standard of care (i.e. use&#xD;
      of intraoperative parathyroid hormone testing).&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. Cost-analysis to determine savings of omission of intraoperative PTH testing.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo standard minimally invasive parathyroidectomy without PTH testing during&#xD;
      surgery.&#xD;
&#xD;
      After completion of study, patients are followed up at 2 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 12, 2016</start_date>
  <completion_date type="Actual">December 24, 2018</completion_date>
  <primary_completion_date type="Actual">July 12, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cure of primary hyperparathyroidism following surgery with intraoperative PTH omission</measure>
    <time_frame>At 2 weeks</time_frame>
    <description>Will be evaluated using a binomial exact test. If all N=60 patients achieve cure then the proposed surgery with intraoperative PTH testing committed will be considered non inferior. A 95% confidence interval about pi will be obtained.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-operative cost analysis</measure>
    <time_frame>At 2 weeks</time_frame>
    <description>cost analysis will be based on operative time and omission of intraoperative PTH levels.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Parathyroid Gland Adenoma</condition>
  <condition>Primary Hyperparathyroidism</condition>
  <arm_group>
    <arm_group_label>Supportive Care (parathyroidectomy)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo standard minimally invasive parathyroidectomy without PTH testing during surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Supportive Care (parathyroidectomy)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Parathyroidectomy</intervention_name>
    <description>Undergo parathyroidectomy</description>
    <arm_group_label>Supportive Care (parathyroidectomy)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Positive 4 dimensional computed tomography (4D CT) for single gland (adenoma) primary&#xD;
             hyperparathyroidism&#xD;
&#xD;
          -  Preoperative serum calcium levels &gt;= 10.9 mg/dL&#xD;
&#xD;
          -  Preoperative parathyroid hormone (PTH) elevated beyond normal range or inappropriately&#xD;
             high for associated calcium level&#xD;
&#xD;
          -  Patient has no history of prior neck surgery or external radiation to neck for&#xD;
             malignant conditions&#xD;
&#xD;
          -  Have an Eastern Cooperative Oncology Group (ECOG) performance status of =&lt; 2&#xD;
&#xD;
          -  Subject or legal representative must understand the investigational nature of this&#xD;
             study and sign an Independent Ethics Committee/Institutional Review Board approved&#xD;
             written informed consent form prior to receiving any study related procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has recurrent hyperparathyroidism&#xD;
&#xD;
          -  4D CT positive for multiple gland disease&#xD;
&#xD;
          -  Patient has inability to tolerate 4D CT scan (for example; contrast intravenous (IV)&#xD;
             allergy, claustrophobia, renal disease)&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements&#xD;
&#xD;
          -  Pregnant or nursing female subjects; may be determined in the preoperative evaluation&#xD;
&#xD;
          -  Unwilling or unable to follow protocol requirements&#xD;
&#xD;
          -  Any condition which in the investigator's opinion deems the subject an unsuitable&#xD;
             candidate to undergo observational study (may also include preoperative testing&#xD;
             results including electrocardiography [EKG], chest x-ray, or pulmonary function tests&#xD;
             that preclude a wide excision in the operating room)&#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>Moshim Kukar</last_name>
    <role>Principal Investigator</role>
    <affiliation>Roswell Park Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Roswell Park Cancer Institute</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14263</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>August 9, 2021</last_update_submitted>
  <last_update_submitted_qc>August 9, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2021</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>Adenoma</mesh_term>
    <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/NCT03011736
org study id: I 274915
secondary id: NCI-2016-01974
secondary id: I 274915
nct id: NCT03011736
lead sponsor: 
has dmc: Yes
This clinical trial studies the omission of intact parathyroid hormone testing during surgery
      in treating patients with primary hyperparathyroidism. Omission of intact parathyroid hormone
      testing during parathyroid gland removal may help patients with primary hyperparathyroidism
      to decrease their time under anesthesia, and decrease the overall time and cost of surgery.
PRIMARY OBJECTIVES:

      I. Determine the non-inferiority of omission of parathyroid hormone (PTH) in patients who
      meet the biochemical and radiological criteria compared to current standard of care (i.e. use
      of intraoperative parathyroid hormone testing).

      SECONDARY OBJECTIVES:

      I. Cost-analysis to determine savings of omission of intraoperative PTH testing.

      OUTLINE:

      Patients undergo standard minimally invasive parathyroidectomy without PTH testing during
      surgery.

      After completion of study, patients are followed up at 2 weeks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Cure of primary hyperparathyroidism following surgery with intraoperative PTH omission
time frame: At 2 weeks
description: Will be evaluated using a binomial exact test. If all N=60 patients achieve cure then the proposed surgery with intraoperative PTH testing committed will be considered non inferior. A 95% confidence interval about pi will be obtained.
measure: Post-operative cost analysis
time frame: At 2 weeks
description: cost analysis will be based on operative time and omission of intraoperative PTH levels.
arm group label: Supportive Care (parathyroidectomy)
arm group type: Experimental
description: Patients undergo standard minimally invasive parathyroidectomy without PTH testing during surgery.
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Supportive Care (parathyroidectomy)
intervention type: Procedure
intervention name: Parathyroidectomy
description: Undergo parathyroidectomy
arm group label: Supportive Care (parathyroidectomy)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Moshim Kukar
role: Principal Investigator
affiliation: Roswell Park Cancer Institute
facility: 
country: United States
responsible party type: Sponsor
mesh term: Adenoma
mesh term: Hyperparathyroidism
mesh term: Hyperparathyroidism, Primary