<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/NCT04415502</url>
  </required_header>
  <id_info>
    <org_study_id>CTHRC1 in RA</org_study_id>
    <nct_id>NCT04415502</nct_id>
  </id_info>
  <brief_title>CTHRC1: A Biomarker for Evaluation of Rheumatoid Arthritis Disease Activity</brief_title>
  <official_title>CTHRC1: A Biomarker for Evaluation of Rheumatoid Arthritis Disease Activity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut 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>
      The purpose of the study is to determine whether plasma levels of the collagen triple helix&#xD;
      repeat containing (CTHRC1) protein can serve as a blood-based biomarker for diagnosis of&#xD;
      rheumatoid arthritis (RA) ,and furthermore its correlation with disease activity&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rheumatoid arthritis (RA) is a chronic, progressive, autoimmune disease of synovial joints.&#xD;
      Characterized by periods of flares with high disease activity involving both a systemic&#xD;
      immune response and tissue-specific inflammatory events that can lead to erosive joint and&#xD;
      bone destruction and subsequent disability . Currently, diagnosis of RA is based mainly on&#xD;
      the extent of tenderness and swelling of the joints , levels of acute-phase reactants such as&#xD;
      C-reactive protein (CRP) ,erythrocyte sedimentation rate(ESR) , high titers of rheumatoid&#xD;
      factor (RF) and high titers of antibodies against cyclic citrullinated peptide (anti-CCP) in&#xD;
      the plasma .Recently, reported increased levels of collagen triple helix repeat containing 1&#xD;
      protein (CTHRC1) are strongly associated with the severity of murine proteoglycan-induced&#xD;
      arthritis and collagen antibody-induced murine arthritis (CAIA) , further CTHRC1 expression&#xD;
      in murine experimental arthritis is increased in the synovium and specifically detected in&#xD;
      activated murine , located at the synovial intimal lining and at the bone-pannus interface&#xD;
      .Of interest,The expression pattern of CTHRC1 in pannus, its role in the function of FLS&#xD;
      relevant to cartilage damage in RA, and CTHRC1's association with disease severity in murine&#xD;
      arthritis raised the question of whether CTHRC1 could be used as a marker for RA diagnosis&#xD;
      and monitoring of disease activity in patients .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2020</start_date>
  <completion_date type="Anticipated">May 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>CTHRC1 in RA</measure>
    <time_frame>One year</time_frame>
    <description>Measuring of CTHRc1 in Rheumatoid arthritis patients.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CTHRc1 and RA disease activity</measure>
    <time_frame>One year</time_frame>
    <description>Correlation of CTHRc1levels with RA disease activity</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Measuring of CTHRc1 , its correlation with RAdisease activity</arm_group_label>
    <description>Measuring of CTHRc1 levels and its correlation with RA disease activity</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Measuring of CTHRc1 levels and its correlation with RA disease activity&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients diagnosed as RA&#xD;
&#xD;
          -  age more than 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other rheumatological diseases Malignancies Hepatic diseases&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Lobna Amer Araby Ahmed, Master</last_name>
    <phone>01019313530</phone>
    <email>Lobnaamer20@gmail.com</email>
  </overall_contact>
  <reference>
    <citation>Chewick S. Infection control demand administrative support. Dimens Health Serv. 1975 Dec;52(12):40-1. No abstract available.</citation>
    <PMID>1305</PMID>
  </reference>
  <reference>
    <citation>Lumholtz IB. [Nurses' drug information: therapeutic action group: benzodiazepine derivatives. 2]. Sygeplejersken. 1975 Sep 24;75(38):15. No abstract available. Danish.</citation>
    <PMID>803</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 31, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>June 2, 2020</last_update_submitted>
  <last_update_submitted_qc>June 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Lobna Amer Araby Ahmed</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Rheumatoid</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/NCT04415502
org study id: CTHRC1 in RA
nct id: NCT04415502
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to determine whether plasma levels of the collagen triple helix
      repeat containing (CTHRC1) protein can serve as a blood-based biomarker for diagnosis of
      rheumatoid arthritis (RA) ,and furthermore its correlation with disease activity
Rheumatoid arthritis (RA) is a chronic, progressive, autoimmune disease of synovial joints.
      Characterized by periods of flares with high disease activity involving both a systemic
      immune response and tissue-specific inflammatory events that can lead to erosive joint and
      bone destruction and subsequent disability . Currently, diagnosis of RA is based mainly on
      the extent of tenderness and swelling of the joints , levels of acute-phase reactants such as
      C-reactive protein (CRP) ,erythrocyte sedimentation rate(ESR) , high titers of rheumatoid
      factor (RF) and high titers of antibodies against cyclic citrullinated peptide (anti-CCP) in
      the plasma .Recently, reported increased levels of collagen triple helix repeat containing 1
      protein (CTHRC1) are strongly associated with the severity of murine proteoglycan-induced
      arthritis and collagen antibody-induced murine arthritis (CAIA) , further CTHRC1 expression
      in murine experimental arthritis is increased in the synovium and specifically detected in
      activated murine , located at the synovial intimal lining and at the bone-pannus interface
      .Of interest,The expression pattern of CTHRC1 in pannus, its role in the function of FLS
      relevant to cartilage damage in RA, and CTHRC1's association with disease severity in murine
      arthritis raised the question of whether CTHRC1 could be used as a marker for RA diagnosis
      and monitoring of disease activity in patients .
observational model: Case-Control
time perspective: Prospective
measure: CTHRC1 in RA
time frame: One year
description: Measuring of CTHRc1 in Rheumatoid arthritis patients.
measure: CTHRc1 and RA disease activity
time frame: One year
description: Correlation of CTHRc1levels with RA disease activity
arm group label: Measuring of CTHRc1 , its correlation with RAdisease activity
description: Measuring of CTHRc1 levels and its correlation with RA disease activity
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Lobna Amer Araby Ahmed, Master
phone: 01019313530
email: Lobnaamer20@gmail.com
citation: Chewick S. Infection control demand administrative support. Dimens Health Serv. 1975 Dec;52(12):40-1. No abstract available.
PMID: 1305
citation: Lumholtz IB. [Nurses' drug information: therapeutic action group: benzodiazepine derivatives. 2]. Sygeplejersken. 1975 Sep 24;75(38):15. No abstract available. Danish.
PMID: 803
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Lobna Amer Araby Ahmed
investigator title: Principal investigator
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid