<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/NCT03015688</url>
  </required_header>
  <id_info>
    <org_study_id>2012-06-01</org_study_id>
    <nct_id>NCT03015688</nct_id>
  </id_info>
  <brief_title>the New Biomarker of the Knee Osteoarthritis Knee Osteoarthritis Occurrence and Progression</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shihezi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shihezi University</source>
  <brief_summary>
    <textblock>
      It was previously proved an association of TGF-β1 and PDGF-BB with the pathogenesis of&#xD;
      osteoarthritis (OA) by experiments of OA animal models. In this study, we aimed to determine&#xD;
      whether serum concentrations of TGF-β1, PDGF-BB and CTX-1 were related to the knee OA. knee&#xD;
      OA cases were collected from the first affiliated hospital of Shihezi university and healthy&#xD;
      controls were recruited from the community. The severity of knee OA was defined as&#xD;
      kellgren-lawrence (K-L) classification criteria.Serum levels of chemical biomarkers were&#xD;
      compared between knee OA cases and controls or among K-L grade 2 to grade 4 groups. The serum&#xD;
      concentrations of the TGF-β1, PDGF-BB and CTX-1 were determined by ELISA .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Serum levels of Transforming Growth Factor Beta1 (TGF-β1) and Platelet Derived Growth Factor BB (PDGF-BB) may be novel biomarkers in knee osteoarthritis</measure>
    <time_frame>3 years</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">460</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>knee OA</arm_group_label>
    <description>OA diagnosis was on the basis of the diagnosis and treatment guideline of the American Academy of Orthopedic Surgeons Participants who met the following criteria were excluded：the knee OA concomitant with hip OA, suppurative and rheumatoid arthritis, gout patients, patients who underwent knee arthroscopy surgery within 6 months, bilateral or unilateral knee replacements, the knee joint trauma patients, histories of glucocorticoid and/or sterol hormones.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>&quot;no often have pain, aching or stiffness in your Left/right knee during last month&quot;,&quot;no Left/right knee trauma history&quot;,&quot;no histories of glucocorticoid and/or sterol hormones&quot; normal knee X-ray images,</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>x-ray images</intervention_name>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>knee OA</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        210 patients diagnosed with knee OA in clinics were found in hospital patients .&#xD;
&#xD;
        Healthy controls were recruited from community questionnaires in Shihezi city, Xinjiang&#xD;
        province, China.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  OA diagnosis was on the basis of the diagnosis and treatment guideline of the American&#xD;
             Academy of Orthopedic Surgeons&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants who met the following criteria were excluded：&#xD;
&#xD;
          -  the knee OA concomitant with hip OA,&#xD;
&#xD;
          -  suppurative and rheumatoid arthritis,&#xD;
&#xD;
          -  gout patients,&#xD;
&#xD;
          -  patients who underwent knee arthroscopy surgery within 6 months,&#xD;
&#xD;
          -  bilateral or unilateral knee replacements,&#xD;
&#xD;
          -  the knee joint trauma patients,&#xD;
&#xD;
          -  histories of glucocorticoid and/or sterol hormones.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>38 Years</minimum_age>
    <maximum_age>78 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>January 9, 2017</last_update_submitted>
  <last_update_submitted_qc>January 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 10, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shihezi University</investigator_affiliation>
    <investigator_full_name>Jianwei He</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Biomarkers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</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/NCT03015688
org study id: 2012-06-01
nct id: NCT03015688
lead sponsor: 
It was previously proved an association of TGF-β1 and PDGF-BB with the pathogenesis of
      osteoarthritis (OA) by experiments of OA animal models. In this study, we aimed to determine
      whether serum concentrations of TGF-β1, PDGF-BB and CTX-1 were related to the knee OA. knee
      OA cases were collected from the first affiliated hospital of Shihezi university and healthy
      controls were recruited from the community. The severity of knee OA was defined as
      kellgren-lawrence (K-L) classification criteria.Serum levels of chemical biomarkers were
      compared between knee OA cases and controls or among K-L grade 2 to grade 4 groups. The serum
      concentrations of the TGF-β1, PDGF-BB and CTX-1 were determined by ELISA .
observational model: Case-Control
time perspective: Cross-Sectional
measure: Serum levels of Transforming Growth Factor Beta1 (TGF-β1) and Platelet Derived Growth Factor BB (PDGF-BB) may be novel biomarkers in knee osteoarthritis
time frame: 3 years
arm group label: knee OA
description: OA diagnosis was on the basis of the diagnosis and treatment guideline of the American Academy of Orthopedic Surgeons Participants who met the following criteria were excluded：the knee OA concomitant with hip OA, suppurative and rheumatoid arthritis, gout patients, patients who underwent knee arthroscopy surgery within 6 months, bilateral or unilateral knee replacements, the knee joint trauma patients, histories of glucocorticoid and/or sterol hormones.
arm group label: Control
description: "no often have pain, aching or stiffness in your Left/right knee during last month","no Left/right knee trauma history","no histories of glucocorticoid and/or sterol hormones" normal knee X-ray images,
intervention type: Radiation
intervention name: x-ray images
arm group label: Control
arm group label: knee OA
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 38 Years
maximum age: 78 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Shihezi University
investigator full name: Jianwei He
investigator title: Principal investigator
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee