<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/NCT03039439</url>
  </required_header>
  <id_info>
    <org_study_id>PA15-0928</org_study_id>
    <secondary_id>NCI-2018-01317</secondary_id>
    <secondary_id>PA15-0928</secondary_id>
    <secondary_id>P30CA016672</secondary_id>
    <nct_id>NCT03039439</nct_id>
  </id_info>
  <brief_title>Molecular and Immunohistochemical Profiling of Tumors in Patients With Parathyroid Tumors</brief_title>
  <official_title>Molecular and Immunohistochemical Profiling of Tumor From Patients With Parathyroid Tumors for Evaluation of Targeted Agents</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>M.D. Anderson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>M.D. Anderson Cancer Center</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>
      This trial studies molecular and immunohistochemical profiling of tumors in patients with&#xD;
      parathyroid tumors. Studying molecular and immunohistochemical profiling of tumors may help&#xD;
      doctors avoid inconsistencies in diagnosis, unnecessary or incomplete surgery, surgical&#xD;
      morbidity, psychological stress, and inadequate follow up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To determine the differences in clinical behavior and immunohistochemical (IHC) biomarkers&#xD;
      between parathyroid carcinoma (PC), atypical neoplasm (AN) and parathyroid adenoma (PA).&#xD;
&#xD;
      II. To determine which potential genes can be used in patients with parathyroid tumors for&#xD;
      diagnostic purposes.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Previously collected tumor tissue and blood samples are analyzed via immunohistochemical&#xD;
      profiling for identifying potential genes showing molecular aberrations as other types of&#xD;
      cancer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 24, 2015</start_date>
  <completion_date type="Anticipated">November 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2020</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>Biomarker levels</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>Will be reported as 0 (negative), 1 (low intensity), 2 (medium intensity), or 3 (high intensity). Sensitivity, specificity, and accuracy will be reported for each cutoff for each biomarker separately to categorize tumor types. Receiver operating characteristic (ROC) analysis will be employed to graphically summarize the tradeoffs between sensitivity and specificity for different cutoffs. Several different combinations of tumor types are of interest: parathyroid carcinoma (PC) versus (vs.) atypical neoplasm (AN), PC vs. parathyroid adenoma (PA), PN vs. PA, PC/AN vs. PA, and PC vs. AN/PA. Separately analyses will be performed for each. Following univariable analyses, a multivariable logistic regression model will be fit (again, separately for each combination of tumor types) to assess the ability of multiple markers to classify patients, and ROC analysis will also be used to summarize the performance of the resulting model.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Identify the potential genes that can be used in patients with parathyroid tumors for diagnostic purposes</measure>
    <time_frame>Up to 4 years</time_frame>
    <description>Genomic analysis of tumor samples will be performed to identify molecular aberrations for which novel targeted therapies have been recently developed. Statistical analyses will be conducted by using 2-sample t-test. Other appropriate statistical methods may also be employed (e.g., non-parametric tests, analysis of variance [ANOVA], or statistical classifications) depending on the endpoint and research interest.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">310</enrollment>
  <condition>Parathyroid Gland Adenoma</condition>
  <condition>Parathyroid Gland Atypical Adenoma</condition>
  <condition>Parathyroid Gland Carcinoma</condition>
  <condition>Primary Hyperparathyroidism</condition>
  <arm_group>
    <arm_group_label>Ancillary-Correlative (laboratory biomarker analysis)</arm_group_label>
    <description>Previously collected tumor tissue and blood samples are analyzed via immunohistochemical profiling for identifying potential genes showing molecular aberrations as other types of cancer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biospecimen Collection</intervention_name>
    <description>Previously collected tumor tissue and blood samples</description>
    <arm_group_label>Ancillary-Correlative (laboratory biomarker analysis)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Laboratory Biomarker Analysis</intervention_name>
    <description>Correlative studies</description>
    <arm_group_label>Ancillary-Correlative (laboratory biomarker analysis)</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Tumor tissue, blood&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Participants in the prospectively maintained parathyroid database within the Department of&#xD;
        Surgical Oncology at the University of Texas MD Anderson Cancer Center (MDACC) or from&#xD;
        collaborating sites, with tissue or blood available from 1968-2015&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient cohort for this study consists of all patients within the prospectively&#xD;
             maintained parathyroid database within the Department of Surgical Oncology at the&#xD;
             University of Texas MD Anderson Cancer Center (MDACC) or from collaborating sites,&#xD;
             with tissue or blood available from 1968-2015, previously consented for the use of the&#xD;
             tissue for research purposes (via Protocols LAB 08-0034, PA11-0695 and LAB03-0320 or&#xD;
             the appropriate external mechanism for collaborating sites).&#xD;
&#xD;
          -  All patients with a known diagnoses of primary hyperparathyroidism (PHPT)&#xD;
             operated/treated in the Department of Surgical Oncology of MDACC or at a collaborating&#xD;
             site. Patients that have provided consent for the use of the tissue or blood for&#xD;
             research purposes will then be considered for our study (via Protocol LAB03-0320 and&#xD;
             LAB 08-0034 or the appropriate external mechanism for collaborating sites).&#xD;
&#xD;
          -  All consented patients with known diagnoses of PHPT with a histopathological diagnosis&#xD;
             of: parathyroid carcinoma, atypical parathyroid neoplasm or parathyroid adenoma. There&#xD;
             will be no restrictions on age, gender, or ethnicity.&#xD;
&#xD;
          -  Selected patients obtained through outside collaboration who meet the selection&#xD;
             criteria for tissue availability and diagnostic suitability for inclusion in the&#xD;
             study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients without tissue available for analysis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nancy Perrier</last_name>
    <role>Principal Investigator</role>
    <affiliation>M.D. Anderson Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nancy D. Perrier</last_name>
    <phone>713-792-6940</phone>
    <email>nperrier@mdanderson.org</email>
  </overall_contact>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nancy Perrier</last_name>
      <phone>713-745-2168</phone>
    </contact>
    <investigator>
      <last_name>Nancy Perrier</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.mdanderson.org</url>
    <description>University of Texas MD Anderson Cancer Center Website</description>
  </link>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 1, 2017</study_first_posted>
  <last_update_submitted>January 9, 2020</last_update_submitted>
  <last_update_submitted_qc>January 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 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>Adenoma</mesh_term>
    <mesh_term>Parathyroid Neoplasms</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/NCT03039439
org study id: PA15-0928
secondary id: NCI-2018-01317
secondary id: PA15-0928
secondary id: P30CA016672
nct id: NCT03039439
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This trial studies molecular and immunohistochemical profiling of tumors in patients with
      parathyroid tumors. Studying molecular and immunohistochemical profiling of tumors may help
      doctors avoid inconsistencies in diagnosis, unnecessary or incomplete surgery, surgical
      morbidity, psychological stress, and inadequate follow up.
PRIMARY OBJECTIVES:

      I. To determine the differences in clinical behavior and immunohistochemical (IHC) biomarkers
      between parathyroid carcinoma (PC), atypical neoplasm (AN) and parathyroid adenoma (PA).

      II. To determine which potential genes can be used in patients with parathyroid tumors for
      diagnostic purposes.

      OUTLINE:

      Previously collected tumor tissue and blood samples are analyzed via immunohistochemical
      profiling for identifying potential genes showing molecular aberrations as other types of
      cancer.
observational model: Case-Only
time perspective: Retrospective
measure: Biomarker levels
time frame: Up to 4 years
description: Will be reported as 0 (negative), 1 (low intensity), 2 (medium intensity), or 3 (high intensity). Sensitivity, specificity, and accuracy will be reported for each cutoff for each biomarker separately to categorize tumor types. Receiver operating characteristic (ROC) analysis will be employed to graphically summarize the tradeoffs between sensitivity and specificity for different cutoffs. Several different combinations of tumor types are of interest: parathyroid carcinoma (PC) versus (vs.) atypical neoplasm (AN), PC vs. parathyroid adenoma (PA), PN vs. PA, PC/AN vs. PA, and PC vs. AN/PA. Separately analyses will be performed for each. Following univariable analyses, a multivariable logistic regression model will be fit (again, separately for each combination of tumor types) to assess the ability of multiple markers to classify patients, and ROC analysis will also be used to summarize the performance of the resulting model.
measure: Identify the potential genes that can be used in patients with parathyroid tumors for diagnostic purposes
time frame: Up to 4 years
description: Genomic analysis of tumor samples will be performed to identify molecular aberrations for which novel targeted therapies have been recently developed. Statistical analyses will be conducted by using 2-sample t-test. Other appropriate statistical methods may also be employed (e.g., non-parametric tests, analysis of variance [ANOVA], or statistical classifications) depending on the endpoint and research interest.
arm group label: Ancillary-Correlative (laboratory biomarker analysis)
description: Previously collected tumor tissue and blood samples are analyzed via immunohistochemical profiling for identifying potential genes showing molecular aberrations as other types of cancer.
intervention type: Procedure
intervention name: Biospecimen Collection
description: Previously collected tumor tissue and blood samples
arm group label: Ancillary-Correlative (laboratory biomarker analysis)
intervention type: Other
intervention name: Laboratory Biomarker Analysis
description: Correlative studies
arm group label: Ancillary-Correlative (laboratory biomarker analysis)
Tumor tissue, blood
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Nancy Perrier
role: Principal Investigator
affiliation: M.D. Anderson Cancer Center
last name: Nancy D. Perrier
phone: 713-792-6940
email: nperrier@mdanderson.org
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
url: http://www.mdanderson.org
description: University of Texas MD Anderson Cancer Center Website
responsible party type: Sponsor
mesh term: Adenoma
mesh term: Parathyroid Neoplasms
mesh term: Hyperparathyroidism
mesh term: Hyperparathyroidism, Primary