<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/NCT04502134</url>
  </required_header>
  <id_info>
    <org_study_id>201910004RIND</org_study_id>
    <nct_id>NCT04502134</nct_id>
  </id_info>
  <brief_title>Association Between Tendon-related Transcription Factor and Ultrasound Images and Shoulder Function</brief_title>
  <official_title>Association Between Tendon-related Transcription Factor and Ultrasound Images and Shoulder Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</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>
      The purpose of this project is to extract effusions and damaged tendons during tendon repair&#xD;
      therapy in patients with tendon tears. Then, we would analyze tendon-related transcription&#xD;
      factors from histology and cytology, and compare changes in tendon with ultrasound images.&#xD;
      Helps to understand the mechanism of tendon lesions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      According to past studies, it is often observed that changes in extracellular matrix, growth&#xD;
      factors, and cytokines in degenerative tendons, indicating that the tendon is constantly&#xD;
      changing. This change will in turn produce a change in the morphology of the tendon tissue in&#xD;
      the ultrasound image. However, there have been few studies in the past literature on the&#xD;
      correlation between constant changes in tendon-specific transcription factors and&#xD;
      characterization on clinical ultrasound images. Therefore, the purpose of this project is to&#xD;
      extract the effusion and damaged tendon while performing tendon repair therapy in patients&#xD;
      with tendon tears, and to analyze the tendon-related transcription factors from histology and&#xD;
      cytology to understand the changes in tendon homeostasis. At the same time, the&#xD;
      interpretation of clinical ultrasound images was combined to establish the relationship&#xD;
      between the biochemical factors of the cell tissues of chronic tendon lesions and the&#xD;
      clinical ultrasound image. This study will help us to understand the mechanism of chronic&#xD;
      tendinopathy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 30, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>2 Months</target_duration>
  <primary_outcome>
    <measure>correlation between ultrasound image and tendon tissue sectioning and staining</measure>
    <time_frame>Month 2</time_frame>
    <description>comparing the image of ultrasound and tendon tissue sectioning and staining to understand the tendon changing in micro stage while the defect could be singed on the ultrasound image</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>tendon-related transcription factors</measure>
    <time_frame>Month 1</time_frame>
    <description>Tendon tissue sectioning and staining Immunohistochemical staining DNA microarray Tendon cell culture Flow cytometry Real-time quantitative reverse transcription polymerase chain reaction RNA-interference-mediated gene silencing</description>
  </secondary_outcome>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Rotator Cuff Tears</condition>
  <condition>Rotator Cuff Tendinosis</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      rotator cuff tendon fragments collecting from rotator cuff tendon repair surgery&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Ultrasound diagnosis of damage to the shoulder rotator tendon, calcification, acromion&#xD;
        bursitis or viscous shoulder capsule&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age older than 20 y&#xD;
&#xD;
          -  shoulder pain more than 3 months and Visual Analogue Scale (VAS) &gt;4&#xD;
&#xD;
          -  shoulder tendon defect on ultrasound images&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  diagnosis of cervical radiculopathy or other central or peripheral neuropathy&#xD;
&#xD;
          -  rheumatoid arthritis or other autoimmune diseases&#xD;
&#xD;
          -  have received any shoulder joint injection within three months&#xD;
&#xD;
          -  tumor or systematic inflammation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Chao Yuan-Hung, PhD</last_name>
    <phone>0933121572</phone>
    <email>yuanhungchao@ntu.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100025</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chao Yuan-Hung, PhD</last_name>
      <phone>0933121572</phone>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>August 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>November 20, 2020</last_update_submitted>
  <last_update_submitted_qc>November 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 23, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ultrasonography</keyword>
  <keyword>rotator cuff tendinopathy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tendinopathy</mesh_term>
    <mesh_term>Rotator Cuff Injuries</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/NCT04502134
org study id: 201910004RIND
nct id: NCT04502134
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this project is to extract effusions and damaged tendons during tendon repair
      therapy in patients with tendon tears. Then, we would analyze tendon-related transcription
      factors from histology and cytology, and compare changes in tendon with ultrasound images.
      Helps to understand the mechanism of tendon lesions.
According to past studies, it is often observed that changes in extracellular matrix, growth
      factors, and cytokines in degenerative tendons, indicating that the tendon is constantly
      changing. This change will in turn produce a change in the morphology of the tendon tissue in
      the ultrasound image. However, there have been few studies in the past literature on the
      correlation between constant changes in tendon-specific transcription factors and
      characterization on clinical ultrasound images. Therefore, the purpose of this project is to
      extract the effusion and damaged tendon while performing tendon repair therapy in patients
      with tendon tears, and to analyze the tendon-related transcription factors from histology and
      cytology to understand the changes in tendon homeostasis. At the same time, the
      interpretation of clinical ultrasound images was combined to establish the relationship
      between the biochemical factors of the cell tissues of chronic tendon lesions and the
      clinical ultrasound image. This study will help us to understand the mechanism of chronic
      tendinopathy.
observational model: Other
time perspective: Cross-Sectional
measure: correlation between ultrasound image and tendon tissue sectioning and staining
time frame: Month 2
description: comparing the image of ultrasound and tendon tissue sectioning and staining to understand the tendon changing in micro stage while the defect could be singed on the ultrasound image
measure: tendon-related transcription factors
time frame: Month 1
description: Tendon tissue sectioning and staining Immunohistochemical staining DNA microarray Tendon cell culture Flow cytometry Real-time quantitative reverse transcription polymerase chain reaction RNA-interference-mediated gene silencing
rotator cuff tendon fragments collecting from rotator cuff tendon repair surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Chao Yuan-Hung, PhD
phone: 0933121572
email: yuanhungchao@ntu.edu.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Tendinopathy
mesh term: Rotator Cuff Injuries