<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/NCT02218554</url>
  </required_header>
  <id_info>
    <org_study_id>CL-BNJ-001-PR</org_study_id>
    <nct_id>NCT02218554</nct_id>
  </id_info>
  <brief_title>Performance Evaluation of the Micromedic BRONJ Risk Assessment in Vitro Diagnostic Assay</brief_title>
  <acronym>BRONJ</acronym>
  <official_title>Performance Evaluation of the Micromedic BRONJ Risk Assessment in Vitro Diagnostic Assay.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Micromedic Technologies Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Micromedic Technologies Ltd</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the performance of the Micromedic BRONJ Risk Assessment in vitro assay (the&#xD;
      &quot;BRONJ Assay&quot;) in identifying Multiple Myeloma (MM) and/or other cancer subjects at risk for&#xD;
      developing Bisphosphonate-related Osteonecrosis of the Jaw (BRONJ) following intravenous (IV)&#xD;
      administration of Bisphosphonates (BP).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Micromedic BRONJ Assay is intended for the qualitative analysis of genetic changes which&#xD;
      may be indicative of increased risk to develop BRONJ osteonecrosis of the jaw (ONJ) following&#xD;
      IV administration of drugs of the Bisphosphonate family.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2012</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>For each subject, the primary endpoint is the presence or absence of SNPs or other genetic alterations obtained from the assay for blood samples</measure>
    <time_frame>up to 2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>For each subject, the secondary endpoint is the presence or absence of additional/alternative SNPs or other genetic alterations using GWAS analysis and/or Full Exome Sequencing (FES) from the assay for blood samples</measure>
    <time_frame>up to 2 years</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Safety endpoints will include adverse events (AEs), including serious AEs (SAEs) whether or not deemed related to study procedures</measure>
    <time_frame>2 years</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Bisphosphonate-related Osteonecrosis of the Jaw</condition>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subject has been diagnosed with BRONJ</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subject has not developed any signs or symptoms of BRONJ</description>
  </arm_group>
  <intervention>
    <intervention_type>Genetic</intervention_type>
    <intervention_name>BRONJ</intervention_name>
    <description>collection of the blood sample from the subject for evaluation of the Micromedic BRONJ Risk Assessment in vitro Diagnostic Assay</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Inclusion Criteria Study Group (all of the following):&#xD;
&#xD;
          1. Subject is ≥18 years old&#xD;
&#xD;
          2. Subject is or was a Multiple Myeloma and/or other cancer patient who is or has been IV&#xD;
             treated with the BP zoledronic acid and/or pamidronate disodium; Or; Subject is or was&#xD;
             a Multiple Myeloma and/or other cancer patient who is or has been IV treated with the&#xD;
             BP zoledronic acid and/or pamidronate disodium and was also treated by oral BP such as&#xD;
             sodium alendronate, and in the opinion of the PI, IV treatment was significant enough&#xD;
             to be considered as the cause for BRONJ&#xD;
&#xD;
          3. Subject has been diagnosed with BRONJ at stages 1 or 2 or 3 according to AAOMS&#xD;
             (American Association of Oral and Maxillofacial Surgeons)&#xD;
&#xD;
          4. Subject has signed the informed consent or consent can be waived&#xD;
&#xD;
        Inclusion Criteria Control Group (all of the following):&#xD;
&#xD;
          1. Subject is ≥18 years old&#xD;
&#xD;
          2. Subject is or was a Multiple Myeloma and/or other cancer patient who is, or has been&#xD;
             IV treated with the BP zoledronic acid and/or pamidronate disodium for at least two&#xD;
             (2) years (continuously or cumulatively)&#xD;
&#xD;
          3. Subject has not developed any signs or symptoms of BRONJ&#xD;
&#xD;
          4. Subject has signed the informed consent or consent can be waived&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject has been treated with irradiation to the jaws or head and neck at levels&#xD;
             exceeding 35 Gy&#xD;
&#xD;
          2. Pregnant or lactating women&#xD;
&#xD;
          3. Subject has been treated with either bevacizumab or sunitimib&#xD;
&#xD;
          4. Subject has been treated with Allogeneic hematopoietic stem cell transplantation&#xD;
             (HSCT)&#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>Noam Yarom, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sheba MC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Noam Yarom, Dr.</last_name>
    <phone>972-35303819</phone>
    <email>noamyar@post.tau.ac.il</email>
  </overall_contact>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Tel Hashomer</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Noam Yarom, Dr.</last_name>
    </contact>
    <investigator>
      <last_name>Noam Yarom, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Tel Hashomer</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Noam Yarom, Dr</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>May 2014</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 18, 2014</study_first_posted>
  <last_update_submitted>August 14, 2014</last_update_submitted>
  <last_update_submitted_qc>August 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>BRONJ</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteonecrosis</mesh_term>
    <mesh_term>Bisphosphonate-Associated Osteonecrosis of the Jaw</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/NCT02218554
org study id: CL-BNJ-001-PR
nct id: NCT02218554
lead sponsor: 
has dmc: No
To evaluate the performance of the Micromedic BRONJ Risk Assessment in vitro assay (the
      "BRONJ Assay") in identifying Multiple Myeloma (MM) and/or other cancer subjects at risk for
      developing Bisphosphonate-related Osteonecrosis of the Jaw (BRONJ) following intravenous (IV)
      administration of Bisphosphonates (BP).
The Micromedic BRONJ Assay is intended for the qualitative analysis of genetic changes which
      may be indicative of increased risk to develop BRONJ osteonecrosis of the jaw (ONJ) following
      IV administration of drugs of the Bisphosphonate family.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: For each subject, the primary endpoint is the presence or absence of SNPs or other genetic alterations obtained from the assay for blood samples
time frame: up to 2 years
measure: For each subject, the secondary endpoint is the presence or absence of additional/alternative SNPs or other genetic alterations using GWAS analysis and/or Full Exome Sequencing (FES) from the assay for blood samples
time frame: up to 2 years
measure: Safety endpoints will include adverse events (AEs), including serious AEs (SAEs) whether or not deemed related to study procedures
time frame: 2 years
arm group label: Study Group
arm group type: Experimental
description: Subject has been diagnosed with BRONJ
arm group label: Control Group
arm group type: No Intervention
description: Subject has not developed any signs or symptoms of BRONJ
intervention type: Genetic
intervention name: BRONJ
description: collection of the blood sample from the subject for evaluation of the Micromedic BRONJ Risk Assessment in vitro Diagnostic Assay
arm group label: Study Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Noam Yarom, Dr.
role: Principal Investigator
affiliation: Sheba MC
last name: Noam Yarom, Dr.
phone: 972-35303819
email: noamyar@post.tau.ac.il
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Osteonecrosis
mesh term: Bisphosphonate-Associated Osteonecrosis of the Jaw