<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/NCT02234388</url>
  </required_header>
  <id_info>
    <org_study_id>2014-311</org_study_id>
    <secondary_id>Robin J. Sillau Fund</secondary_id>
    <nct_id>NCT02234388</nct_id>
  </id_info>
  <brief_title>Undifferentiated Connective Tissue Disease Registry</brief_title>
  <acronym>UCTD Registry</acronym>
  <official_title>Undifferentiated Connective Tissue Disease Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital for Special Surgery, New York</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital for Special Surgery, New York</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This registry has been established to gain a better understanding of the clinical and&#xD;
      emotional presentations of patients with undifferentiated connective tissue disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this research registry is to gather information about clinical symptoms and&#xD;
      laboratory test results in patients with undifferentiated connective tissue disease (UCTD).&#xD;
      Analysis of this information may help to better predict the prognosis for patients with this&#xD;
      form of autoimmune disease, and may identify risk factors for progression to more specific&#xD;
      connective tissue diseases such as systemic lupus. This is done by collecting information&#xD;
      from your medical records including clinical history, physical examination, and lab test&#xD;
      results, and by asking you questions about specific symptoms you may have such as joint pain,&#xD;
      rashes, and other common symptoms of UCTD. This information will be stored in a database, and&#xD;
      used at a later time for research studies. All future research studies using information in&#xD;
      this registry will be subject to oversight by HSS's Institutional Review Board (which is&#xD;
      responsible for oversight of research at HSS involving human subjects). All patients who seek&#xD;
      or receive medical care at HSS for undifferentiated connective tissue disease will be invited&#xD;
      to participate in this registry.&#xD;
&#xD;
      Most future research studies involving this registry will only use the information in this&#xD;
      registry, and therefore will not require the further involvement or additional informed&#xD;
      consent of participants in the registry. But the information in this registry may also be&#xD;
      used to identify patients who may be eligible to participate in certain future research&#xD;
      studies conducted by HSS that relate to their particular disease, condition, or treatment and&#xD;
      for which information is needed that is not in the registry. If you are identified (based on&#xD;
      information about you in the registry) as being potentially eligible for a future research&#xD;
      study that relates to your particular disease, condition, or treatment, you may be contacted&#xD;
      to find out if you would be interested in participating in the research study. If you are&#xD;
      interested, the research study would be fully explained to you, and you would have to give&#xD;
      your informed consent before you could participate. If you participate in this registry, you&#xD;
      will not be required to participate in any future research study that HSS contacts you about.&#xD;
&#xD;
      By participating in this registry, you will not be asked to do anything that would not&#xD;
      ordinarily be done as a matter of routine care at HSS including clinical assessments,&#xD;
      laboratory tests and radiology procedures. During your routine visits we will be recording&#xD;
      all of the information about you that relates to your disease, condition, or treatment and&#xD;
      will include that information in the registry. Your participation will involve a minimum of&#xD;
      one yearly visit at the time of your visit to your own rheumatologist. Most study visits are&#xD;
      expected to last 10 - 15 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Anticipated">March 31, 2027</completion_date>
  <primary_completion_date type="Anticipated">March 31, 2027</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Years</target_duration>
  <primary_outcome>
    <measure>Change in SF-36 Score</measure>
    <time_frame>3 years</time_frame>
    <description>Patient questionnaire that measures health-related quality of life.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Fatigue Severity Scale Score</measure>
    <time_frame>3 years</time_frame>
    <description>Evaluates the impact of fatigue on the patient.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Beck Depression Inventory Score</measure>
    <time_frame>3 years</time_frame>
    <description>Self-reported depression severity questionnaire</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Connective Tissue Disease Criteria</measure>
    <time_frame>3 years</time_frame>
    <description>The physician will monitor which characteristics from each connective tissue disease the patient presents with. This will show how UCTD progresses and what the most prominent characteristics of the disease are.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CBC</measure>
    <time_frame>3 years</time_frame>
    <description>Patients may have this clinical lab test ordered to monitor their hemoglobin, hematocrit, and platlet counts.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comprehensive Metabolic Panel</measure>
    <time_frame>3 years</time_frame>
    <description>Patients may have this clinical laboratory test ordered to monitor their electrolytes, creatinine, glucose levels, phosphates, and blood protein levels.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cholesterol Profile</measure>
    <time_frame>3 years</time_frame>
    <description>Patients may have this clinical laboratory test ordered to monitor their blood cholesterol levels.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinalysis</measure>
    <time_frame>3 years</time_frame>
    <description>Patients may have this clinical laboratory test ordered to monitor their health and the presence of any infections.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Undifferentiated Connective Tissue Disease</condition>
  <arm_group>
    <arm_group_label>Registry Participants</arm_group_label>
    <description>All patients who participate in the UCTD Registry will be put into this cohort and observed over approximately 3 years.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observation</intervention_name>
    <description>There are no interventions associated with this registry as it is purely observational.</description>
    <arm_group_label>Registry Participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients under the care of any HSS rheumatologist that have been diagnosed with&#xD;
        undifferentiated connective tissue disease.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient under the care of an HSS rheumatologist&#xD;
&#xD;
          -  Positive ANA or a positive anti-ds DNA, anti-Ro/SS-A or other autoantibody on 2 or&#xD;
             more occasions at least 12 weeks apart&#xD;
&#xD;
          -  One or more signs or symptoms of connective tissue disease, including but not limited&#xD;
             to arthralgia, arthritis, myalgia, rash, sicca symptoms, pericarditis, pleuritis,&#xD;
             pulmonary symptoms, peripheral neuropathy, photosensitivity, alopecia, oral or nasal&#xD;
             ulcers, leucopenia, anemia, and abnormal nailfold capillaroscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who meet criteria for well defined CTD including SLE, rheumatoid arthritis,&#xD;
             polymyositis or dermatomyositis, systemic sclerosis, or antiphospholipid syndrome&#xD;
&#xD;
          -  Patients who are less than 18&#xD;
&#xD;
          -  Those unable to give informed consent in English&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital for Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lucy Masto, BS</last_name>
      <phone>917-260-4968</phone>
      <email>mastol@hss.edu</email>
    </contact>
    <contact_backup>
      <last_name>Amaya Smole, BA</last_name>
      <phone>212-774-2960</phone>
      <email>smolea@hss.edu</email>
    </contact_backup>
    <investigator>
      <last_name>Lisa Sammaritano, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>September 3, 2014</study_first_submitted>
  <study_first_submitted_qc>September 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <last_update_submitted>January 9, 2023</last_update_submitted>
  <last_update_submitted_qc>January 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>connective tissue disease</keyword>
  <keyword>registry</keyword>
  <keyword>hospital for special surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Connective Tissue Diseases</mesh_term>
    <mesh_term>Undifferentiated Connective Tissue Diseases</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/NCT02234388
org study id: 2014-311
secondary id: Robin J. Sillau Fund
nct id: NCT02234388
lead sponsor: 
has dmc: No
This registry has been established to gain a better understanding of the clinical and
      emotional presentations of patients with undifferentiated connective tissue disease.
The purpose of this research registry is to gather information about clinical symptoms and
      laboratory test results in patients with undifferentiated connective tissue disease (UCTD).
      Analysis of this information may help to better predict the prognosis for patients with this
      form of autoimmune disease, and may identify risk factors for progression to more specific
      connective tissue diseases such as systemic lupus. This is done by collecting information
      from your medical records including clinical history, physical examination, and lab test
      results, and by asking you questions about specific symptoms you may have such as joint pain,
      rashes, and other common symptoms of UCTD. This information will be stored in a database, and
      used at a later time for research studies. All future research studies using information in
      this registry will be subject to oversight by HSS's Institutional Review Board (which is
      responsible for oversight of research at HSS involving human subjects). All patients who seek
      or receive medical care at HSS for undifferentiated connective tissue disease will be invited
      to participate in this registry.

      Most future research studies involving this registry will only use the information in this
      registry, and therefore will not require the further involvement or additional informed
      consent of participants in the registry. But the information in this registry may also be
      used to identify patients who may be eligible to participate in certain future research
      studies conducted by HSS that relate to their particular disease, condition, or treatment and
      for which information is needed that is not in the registry. If you are identified (based on
      information about you in the registry) as being potentially eligible for a future research
      study that relates to your particular disease, condition, or treatment, you may be contacted
      to find out if you would be interested in participating in the research study. If you are
      interested, the research study would be fully explained to you, and you would have to give
      your informed consent before you could participate. If you participate in this registry, you
      will not be required to participate in any future research study that HSS contacts you about.

      By participating in this registry, you will not be asked to do anything that would not
      ordinarily be done as a matter of routine care at HSS including clinical assessments,
      laboratory tests and radiology procedures. During your routine visits we will be recording
      all of the information about you that relates to your disease, condition, or treatment and
      will include that information in the registry. Your participation will involve a minimum of
      one yearly visit at the time of your visit to your own rheumatologist. Most study visits are
      expected to last 10 - 15 minutes.
observational model: Cohort
time perspective: Prospective
measure: Change in SF-36 Score
time frame: 3 years
description: Patient questionnaire that measures health-related quality of life.
measure: Change in Fatigue Severity Scale Score
time frame: 3 years
description: Evaluates the impact of fatigue on the patient.
measure: Change in Beck Depression Inventory Score
time frame: 3 years
description: Self-reported depression severity questionnaire
measure: Connective Tissue Disease Criteria
time frame: 3 years
description: The physician will monitor which characteristics from each connective tissue disease the patient presents with. This will show how UCTD progresses and what the most prominent characteristics of the disease are.
measure: CBC
time frame: 3 years
description: Patients may have this clinical lab test ordered to monitor their hemoglobin, hematocrit, and platlet counts.
measure: Comprehensive Metabolic Panel
time frame: 3 years
description: Patients may have this clinical laboratory test ordered to monitor their electrolytes, creatinine, glucose levels, phosphates, and blood protein levels.
measure: Cholesterol Profile
time frame: 3 years
description: Patients may have this clinical laboratory test ordered to monitor their blood cholesterol levels.
measure: Urinalysis
time frame: 3 years
description: Patients may have this clinical laboratory test ordered to monitor their health and the presence of any infections.
arm group label: Registry Participants
description: All patients who participate in the UCTD Registry will be put into this cohort and observed over approximately 3 years.
intervention type: Other
intervention name: Observation
description: There are no interventions associated with this registry as it is purely observational.
arm group label: Registry Participants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Connective Tissue Diseases
mesh term: Undifferentiated Connective Tissue Diseases