<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/NCT03279016</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2017-08-28</org_study_id>
    <nct_id>NCT03279016</nct_id>
  </id_info>
  <brief_title>Arthroscopic Guided Synovial Biopsies</brief_title>
  <official_title>Diagnosis of Temporomandibular Joint Arthritic Disease Using Arthroscopic Guided Synovial Biopsies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To detect accuracy of serology in diagnosis of temporomandibular joint arthritis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to a search of previously published studies on accuracy of serology no sensitivity&#xD;
      or specificity data was found regarding accurate detection of arthritis through serology,&#xD;
      hence the aim of this study is to detect accuracy of serology in diagnosis of&#xD;
      temporomandibular joint arthritis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">May 2018</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>accuracy of serology</measure>
    <time_frame>2 years</time_frame>
    <description>To determine the sensitivity or specificity of serology in diagnosis of temporomandibular joint arthritis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rheumatoid factor</measure>
    <time_frame>2 years</time_frame>
    <description>To be measured in a blood sample with (IU/mL) unit as The normal reference range for RF is less than 15 IU/mL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>C-reactive protein</measure>
    <time_frame>2 years</time_frame>
    <description>To be measured in a blood sample with (mg/dL) unit where Normal CRP levels are below 3.0 mg/dL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anti-Cyclic Citrullinated Peptide</measure>
    <time_frame>2 years</time_frame>
    <description>To be measured in a blood sample with (titre-AU)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ANA</measure>
    <time_frame>2 years</time_frame>
    <description>To be measured in a blood sample with binary outcome (positive or negative)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>HLA-B27</measure>
    <time_frame>2 years</time_frame>
    <description>To be measured in a blood sample with binary outcome (positive or negative)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cellular population- type</measure>
    <time_frame>2 years</time_frame>
    <description>Presence of inflammatory cells infiltrate at the synovial membrane biopsy :&#xD;
- type of cells</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cellular population- number of cells</measure>
    <time_frame>2 years</time_frame>
    <description>Presence of inflammatory cells infiltrate at the synovial membrane biopsy:&#xD;
- mean number of cells</description>
  </secondary_outcome>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Temporomandibular Arthritis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patient complaing from arthritis symptoms,an diagnosed as arthritic patient with MRI&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients suffering from TEMPOROMANDIBULAR JOINT ARTHRITIS.&#xD;
&#xD;
          -  Patients should be free from any systemic disease that may affect normal healing and&#xD;
             predictable outcome.&#xD;
&#xD;
          -  Patients who will agree to the consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with any systemic disease that may affect normal healing.&#xD;
&#xD;
          -  Pregnant females.&#xD;
&#xD;
          -  Patients with acute infection.&#xD;
&#xD;
          -  Patients with bony ankyloses.&#xD;
&#xD;
          -  Patients with risk of tumor dissemination.&#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>sameh mekhaimer, professor</last_name>
    <role>Study Director</role>
    <affiliation>professor of oral and maxillofacial surgery,faculty of oral and dental medicine,Cairo university</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>AHMED EISSA, MASTER</last_name>
    <phone>+201147700383</phone>
    <email>drahmedadel75@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Faculty of Oral and Dental Medicine</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Faculty of Oral and Dental Medicine</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>REEM HAMDY, PHD</last_name>
      <phone>+201006250787</phone>
      <email>reemhamdy@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <last_update_submitted>February 4, 2018</last_update_submitted>
  <last_update_submitted_qc>February 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Adel EISSA</investigator_full_name>
    <investigator_title>doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03279016
org study id: CEBD-CU-2017-08-28
nct id: NCT03279016
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To detect accuracy of serology in diagnosis of temporomandibular joint arthritis.
According to a search of previously published studies on accuracy of serology no sensitivity
      or specificity data was found regarding accurate detection of arthritis through serology,
      hence the aim of this study is to detect accuracy of serology in diagnosis of
      temporomandibular joint arthritis.
observational model: Other
time perspective: Retrospective
measure: accuracy of serology
time frame: 2 years
description: To determine the sensitivity or specificity of serology in diagnosis of temporomandibular joint arthritis
measure: Rheumatoid factor
time frame: 2 years
description: To be measured in a blood sample with (IU/mL) unit as The normal reference range for RF is less than 15 IU/mL
measure: C-reactive protein
time frame: 2 years
description: To be measured in a blood sample with (mg/dL) unit where Normal CRP levels are below 3.0 mg/dL.
measure: Anti-Cyclic Citrullinated Peptide
time frame: 2 years
description: To be measured in a blood sample with (titre-AU)
measure: ANA
time frame: 2 years
description: To be measured in a blood sample with binary outcome (positive or negative)
measure: HLA-B27
time frame: 2 years
description: To be measured in a blood sample with binary outcome (positive or negative)
measure: Cellular population- type
time frame: 2 years
description: Presence of inflammatory cells infiltrate at the synovial membrane biopsy :
- type of cells
measure: Cellular population- number of cells
time frame: 2 years
description: Presence of inflammatory cells infiltrate at the synovial membrane biopsy:
- mean number of cells
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: sameh mekhaimer, professor
role: Study Director
affiliation: professor of oral and maxillofacial surgery,faculty of oral and dental medicine,Cairo university
last name: AHMED EISSA, MASTER
phone: +201147700383
email: drahmedadel75@gmail.com
facility: 
status: Completed
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Adel EISSA
investigator title: doctor
mesh term: Arthritis
sharing ipd: Undecided