<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/NCT04402086</url>
  </required_header>
  <id_info>
    <org_study_id>2000026608</org_study_id>
    <nct_id>NCT04402086</nct_id>
  </id_info>
  <brief_title>Rheumatology Patient Registry and Biorepository</brief_title>
  <official_title>Rheumatology Patient Registry and Biorepository</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yale 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 facilitate clinical, basic science, and translational research projects involving the&#xD;
      study of rheumatic diseases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A rheumatology biorepository will be created to permit comparative analyses between the&#xD;
      rheumatic diseases in order to increase the understanding of disease pathogenesis. Patients&#xD;
      seen at Yale clinics diagnosed with rheumatic diseases are invited to participate in this&#xD;
      study. These rheumatic diseases include, but are not limited to: adult onset Still's disease,&#xD;
      ankylosing spondylitis, psoriatic arthritis, reactive arthritis, antiphospholipid syndrome,&#xD;
      systemic lupus erythematosus, Behcet's disease, dermatomyositis, polymyositis, giant cell&#xD;
      arteritis and other vasculitides, Lyme's disease, mixed connective tissue disease,&#xD;
      polymyalgia rheumatica, rheumatoid arthritis, sarcoidosis, systemic sclerosis (scleroderma),&#xD;
      Sjogren's syndrome, and undifferentiated connective tissue disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 4, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2040</completion_date>
  <primary_completion_date type="Anticipated">June 1, 2030</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>Prospective</time_perspective>
  </study_design_info>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>Correlate outcomes and biomarkers of rheumatic diseases</measure>
    <time_frame>10 years</time_frame>
    <description>Evaluate clinical data and biospecimens to correlate outcomes and biomarkers of rheumatic diseases.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">5000</enrollment>
  <condition>Rheumatic Diseases</condition>
  <condition>Adult Onset Still Disease</condition>
  <condition>Ankylosing Spondylitis</condition>
  <condition>Psoriatic Arthritis</condition>
  <condition>Reactive Arthritis</condition>
  <condition>Antiphospholipid Syndrome</condition>
  <condition>Systemic Lupus Erythematosus</condition>
  <condition>Behcet Disease</condition>
  <condition>Dermatomyositis</condition>
  <condition>Polymyositis</condition>
  <condition>Giant Cell Arteritis</condition>
  <condition>Lyme Disease</condition>
  <condition>Mixed Connective Tissue Disease</condition>
  <condition>Polymyalgia Rheumatica</condition>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Sarcoidosis</condition>
  <condition>Systemic Sclerosis</condition>
  <condition>Scleroderma</condition>
  <condition>Sjogren's Syndrome</condition>
  <condition>Undifferentiated Connective Tissue Diseases</condition>
  <arm_group>
    <arm_group_label>Biorepository</arm_group_label>
    <description>Participants with rheumatic diseases who contributed biospecimen samples (blood, saliva, urine, stool, tissue).</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The biorepository will consist of both new and established patients with a rheumatic&#xD;
        autoimmune disease diagnosis who visit a Yale Rheumatology medical facility and agree to&#xD;
        participate in this study. The biorepository will also consist of healthy volunteers who&#xD;
        agree to participate in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for Rheumatology Patients:&#xD;
&#xD;
          -  Patients ≥18 years old with a diagnosis of a rheumatic autoimmune disease including,&#xD;
             but not limited to: adult onset Still's disease, ankylosing spondylitis,&#xD;
             antiphospholipid syndrome, Behcet's disease, dermatomyositis, giant cell arteritis,&#xD;
             mixed connective tissue disease, polymyalgia rheumatica, polymyositis, psoriatic&#xD;
             arthritis, reactive arthritis, rheumatoid arthritis, sarcoidosis, scleroderma,&#xD;
             Sjogren's syndrome, systemic lupus erythematosus, undifferentiated connective tissue&#xD;
             disease and vasculitis.&#xD;
&#xD;
          -  Receiving clinical care at Yale Rheumatology clinics&#xD;
&#xD;
        Exclusion Criteria for Rheumatology Patients:&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
&#xD;
          -  No patients will be excluded based on gender or ethnicity or pregnancy status.&#xD;
&#xD;
          -  Women who are currently pregnant will need to wait to donate a skin biopsy until after&#xD;
             they deliver.&#xD;
&#xD;
          -  Patients allergic to lidocaine or epinephrine or have a history of impaired wound&#xD;
             healing will not be able to donate a skin biopsy.&#xD;
&#xD;
        Inclusion Criteria for Healthy Volunteers:&#xD;
&#xD;
          -  Age ≥ 18 years old&#xD;
&#xD;
          -  No chronic skin conditions&#xD;
&#xD;
          -  No diagnosis of a rheumatic autoimmune disease (e.g., lupus, rheumatoid arthritis)&#xD;
&#xD;
          -  Normal BMI&#xD;
&#xD;
        Exclusion Criteria for Healthy Volunteers:&#xD;
&#xD;
          -  Unable to provide informed consent.&#xD;
&#xD;
          -  Currently pregnant or nursing unless the study goal is to study pregnant or nursing&#xD;
             woman.&#xD;
&#xD;
          -  Allergies to lidocaine or epinephrine (skin biopsies).&#xD;
&#xD;
          -  A history of impaired wound healing (skin biopsies).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Monique Hinchcliff, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yale University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nicolas Page</last_name>
    <phone>203-737-5571</phone>
    <email>scleroderma@yale.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Yale New Haven Hospital</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>203-737-5571</phone>
    </contact>
    <investigator>
      <last_name>Monique Hinchcliff, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>September 13, 2022</last_update_submitted>
  <last_update_submitted_qc>September 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Lyme Disease</mesh_term>
    <mesh_term>Arthritis, Reactive</mesh_term>
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Psoriatic</mesh_term>
    <mesh_term>Spondylitis, Ankylosing</mesh_term>
    <mesh_term>Rheumatic Diseases</mesh_term>
    <mesh_term>Sjogren's Syndrome</mesh_term>
    <mesh_term>Dermatomyositis</mesh_term>
    <mesh_term>Polymyalgia Rheumatica</mesh_term>
    <mesh_term>Polymyositis</mesh_term>
    <mesh_term>Still's Disease, Adult-Onset</mesh_term>
    <mesh_term>Behcet Syndrome</mesh_term>
    <mesh_term>Giant Cell Arteritis</mesh_term>
    <mesh_term>Arteritis</mesh_term>
    <mesh_term>Sarcoidosis</mesh_term>
    <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
    <mesh_term>Scleroderma, Systemic</mesh_term>
    <mesh_term>Collagen Diseases</mesh_term>
    <mesh_term>Connective Tissue Diseases</mesh_term>
    <mesh_term>Mixed Connective Tissue Disease</mesh_term>
    <mesh_term>Undifferentiated Connective Tissue Diseases</mesh_term>
    <mesh_term>Antiphospholipid Syndrome</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Undecided</ipd_description>
  </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/NCT04402086
org study id: 2000026608
nct id: NCT04402086
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To facilitate clinical, basic science, and translational research projects involving the
      study of rheumatic diseases.
A rheumatology biorepository will be created to permit comparative analyses between the
      rheumatic diseases in order to increase the understanding of disease pathogenesis. Patients
      seen at Yale clinics diagnosed with rheumatic diseases are invited to participate in this
      study. These rheumatic diseases include, but are not limited to: adult onset Still's disease,
      ankylosing spondylitis, psoriatic arthritis, reactive arthritis, antiphospholipid syndrome,
      systemic lupus erythematosus, Behcet's disease, dermatomyositis, polymyositis, giant cell
      arteritis and other vasculitides, Lyme's disease, mixed connective tissue disease,
      polymyalgia rheumatica, rheumatoid arthritis, sarcoidosis, systemic sclerosis (scleroderma),
      Sjogren's syndrome, and undifferentiated connective tissue disease.
observational model: Other
time perspective: Prospective
measure: Correlate outcomes and biomarkers of rheumatic diseases
time frame: 10 years
description: Evaluate clinical data and biospecimens to correlate outcomes and biomarkers of rheumatic diseases.
arm group label: Biorepository
description: Participants with rheumatic diseases who contributed biospecimen samples (blood, saliva, urine, stool, tissue).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Monique Hinchcliff, MD
role: Principal Investigator
affiliation: Yale University
last name: Nicolas Page
phone: 203-737-5571
email: scleroderma@yale.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Spondylitis
mesh term: Lyme Disease
mesh term: Arthritis, Reactive
mesh term: Arthritis
mesh term: Arthritis, Psoriatic
mesh term: Spondylitis, Ankylosing
mesh term: Rheumatic Diseases
mesh term: Sjogren's Syndrome
mesh term: Dermatomyositis
mesh term: Polymyalgia Rheumatica
mesh term: Polymyositis
mesh term: Still's Disease, Adult-Onset
mesh term: Behcet Syndrome
mesh term: Giant Cell Arteritis
mesh term: Arteritis
mesh term: Sarcoidosis
mesh term: Lupus Erythematosus, Systemic
mesh term: Scleroderma, Systemic
mesh term: Collagen Diseases
mesh term: Connective Tissue Diseases
mesh term: Mixed Connective Tissue Disease
mesh term: Undifferentiated Connective Tissue Diseases
mesh term: Antiphospholipid Syndrome
mesh term: Syndrome
sharing ipd: Undecided
ipd description: Undecided