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Rheumatology Patient Registry and Biorepository

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ClinicalTrials.gov Identifier: NCT04402086
Recruitment Status : Recruiting
First Posted : May 26, 2020
Last Update Posted : October 8, 2021
Sponsor:
Information provided by (Responsible Party):
Yale University

Study Description
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Brief Summary:
To facilitate clinical, basic science, and translational research projects involving the study of rheumatic diseases.

Condition or disease
Rheumatic Diseases Adult Onset Still Disease Ankylosing Spondylitis Psoriatic Arthritis Reactive Arthritis Antiphospholipid Syndrome Systemic Lupus Erythematosus Behcet Disease Dermatomyositis Polymyositis Giant Cell Arteritis Lyme Disease Mixed Connective Tissue Disease Polymyalgia Rheumatica Rheumatoid Arthritis Sarcoidosis Systemic Sclerosis Scleroderma Sjogren's Syndrome Undifferentiated Connective Tissue Diseases

Detailed Description:
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.
Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Rheumatology Patient Registry and Biorepository
Actual Study Start Date : August 4, 2020
Estimated Primary Completion Date : June 1, 2030
Estimated Study Completion Date : June 1, 2040

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Biorepository
Participants with rheumatic diseases who contributed biospecimen samples (blood, saliva, urine, stool, tissue).


Outcome Measures
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Primary Outcome Measures :
  1. Correlate outcomes and biomarkers of rheumatic diseases [ Time Frame: 10 years ]
    Evaluate clinical data and biospecimens to correlate outcomes and biomarkers of rheumatic diseases.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
The biorepository will consist of both new and established patients with a rheumatic autoimmune disease diagnosis who visit a Yale Rheumatology medical facility and agree to participate in this study. The biorepository will also consist of healthy volunteers who agree to participate in this study.
Criteria

Inclusion Criteria for Rheumatology Patients:

  • Patients ≥18 years old with a diagnosis of a rheumatic autoimmune disease including, but not limited to: adult onset Still's disease, ankylosing spondylitis, antiphospholipid syndrome, Behcet's disease, dermatomyositis, giant cell arteritis, mixed connective tissue disease, polymyalgia rheumatica, polymyositis, psoriatic arthritis, reactive arthritis, rheumatoid arthritis, sarcoidosis, scleroderma, Sjogren's syndrome, systemic lupus erythematosus, undifferentiated connective tissue disease and vasculitis.
  • Receiving clinical care at Yale Rheumatology clinics

Exclusion Criteria for Rheumatology Patients:

  • Unable to provide informed consent
  • No patients will be excluded based on gender or ethnicity or pregnancy status.
  • Women who are currently pregnant will need to wait to donate a skin biopsy until after they deliver.
  • Patients allergic to lidocaine or epinephrine or have a history of impaired wound healing will not be able to donate a skin biopsy.

Inclusion Criteria for Healthy Volunteers:

  • Age ≥ 18 years old
  • No chronic skin conditions
  • No diagnosis of a rheumatic autoimmune disease (e.g., lupus, rheumatoid arthritis)
  • Normal BMI

Exclusion Criteria for Healthy Volunteers:

  • Unable to provide informed consent.
  • Currently pregnant or nursing unless the study goal is to study pregnant or nursing woman.
  • Allergies to lidocaine or epinephrine (skin biopsies).
  • A history of impaired wound healing (skin biopsies).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04402086


Contacts
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Contact: Alyssa Williams 203-737-5571 alyssa.williams@yale.edu

Locations
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United States, Connecticut
Yale New Haven Hospital Recruiting
New Haven, Connecticut, United States, 06510
Contact    203-737-5571      
Principal Investigator: Monique Hinchcliff, MD         
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Monique Hinchcliff, MD Yale University
More Information
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT04402086    
Other Study ID Numbers: 2000026608
First Posted: May 26, 2020    Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spondylitis
Lyme Disease
Arthritis, Reactive
Arthritis
Arthritis, Psoriatic
Spondylitis, Ankylosing
Rheumatic Diseases
Sjogren's Syndrome
Dermatomyositis
Polymyalgia Rheumatica
Polymyositis
Still's Disease, Adult-Onset
Behcet Syndrome
Giant Cell Arteritis
Arteritis
 Sarcoidosis
Lupus Erythematosus, Systemic
Scleroderma, Systemic
Collagen Diseases
Connective Tissue Diseases
Mixed Connective Tissue Disease
Undifferentiated Connective Tissue Diseases
Antiphospholipid Syndrome
Syndrome
Disease
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases
Arthritis, Rheumatoid
Autoimmune Diseases