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Comparative Autoantibody and Immunologic Cell Marker Study

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ClinicalTrials.gov Identifier: NCT02422875
Recruitment Status : Enrolling by invitation
First Posted : April 21, 2015
Last Update Posted : August 2, 2017
Sponsor:
Information provided by (Responsible Party):
Ignacio Sanz, Emory University

Brief Summary:
The purpose of this study is to compare immune phenotype, function, and specificity of B lymphocytes from different developmental stages in autoimmune patients to B cells from infectious disease patients and healthy controls.

Condition or disease
Autoimmune Diseases Lupus Erythematosus, Systemic Communicable Diseases

Detailed Description:

Systemic lupus erythematosus (SLE) is an autoimmune disease (in autoimmune illness, the immune system in the body attacks it's own cells, leading to illness). It is not completely understood how this disease develops in the body. In a normal person, there is a tolerance of antigens (substances that make antibodies, which protect the body from disease-causing agents). Research in mice suggests that defects in certain types of cells can make the body lose this tolerance, therefore recognizing antigens made in the body as foreign, and mounting an immune response to the "self", thus causing autoimmune disease. In this study, the researchers will look at these potentially defective cells in people with SLE and other autoimmune diseases and compare them to cells in healthy participants, as well as looking at the blood of first-degree relatives of people with autoimmune disease.

The study involves blood draws and bone marrow aspirates. Participants may be asked to donate 2/3 to about 9 tablespoons of blood. The volume of blood needed will depend on the experiment being done as different numbers of cells are necessary to run different experiments. Study participants may return for additional blood draws will not donate blood more than twice a week, and will not have more than 16 tablespoons of blood drawn in a one-month period. Participants donating bone marrow will have about 3 ½ tablespoons of bone marrow obtained, which will be drawn with a large needle from the bone located in the back of the hip. Bone marrow participants may be asked to donate up to 7 tablespoons of blood as well, in order to correlate the blood with the bone marrow sample and the populations of cells residing in each. Participants donating bone marrow may donate more than once, but must wait a minimum of 8 weeks between donations.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 3 Days
Official Title: Comparative Autoantibody and Immunologic Cell Marker Study
Study Start Date : August 2012
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020


Group/Cohort
Healthy Controls
Subjects are healthy persons without any autoimmune conditions or infectious diseases
Autoimmune Disease
Subjects diagnosed with autoimmune disease including but not limited to: Systemic Lupus Erythematosus (SLE), Sjögren's Syndrome (SS), Scleroderma, Myositis, Juvenile Idiopathic Arthritis (JIA), Rheumatoid Arthritis (RA), inflammatory arthritis, undifferentiated connective tissue disease, idiopathic thrombocytopenic purpura (ITP), Graft vs Host Disease (GVHD), Autoimmune Lymphoproliferative Syndrome (ALPS) and IgG4-related disease
Infectious Disease
Subjects diagnosed with an infectious disease including but not limited to: Hepatitis C, Epstein Barr Virus (infectious mononucleosis - EBV), Sepsis, Guillain-Barre syndrome (GBS), Mycoplasma pneumoniae or Human Immunodeficiency Virus (HIV)
Autoimmune - Family
Subjects have a brother, sister, mother, father, or child with an autoimmune disease
Vaccination
Subjects have received or will receive a vaccination as part of regular standard of care from their healthcare provider or other outside source



Primary Outcome Measures :
  1. Distribution of autoreactive B cells within bone marrow [ Time Frame: Baseline ]
    B cells will be analyzed using flow cytometry.


Biospecimen Retention:   Samples With DNA
Acquisition and storage of blood and bone marrow samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • Subjects with certain autoimmune conditions or if subjects have brothers, sisters, mother, father, or children with an autoimmune condition
  • Subjects with certain infectious diseases
  • Subjects who are without an autoimmune condition or infectious disease
  • Subjects who have received or will receive a vaccination as part of their regular standard of care from one of their healthcare providers
Criteria

Inclusion Criteria:

  • Signed written informed consent by the subject or, if the subject is unable to provide informed consent, the subject's legal representative may provide consent.
  • Subjects can be of either gender
  • Subjects with autoimmune diseases, and Systemic Lupus Erythematosus (SLE) patients will fulfill the American College of Rheumatology Classification criteria for SLE to be determined by their treating physician but may have incomplete criteria (<4 items). SLE patients are not restricted by treatment or by disease activity as determined by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) or Systemic Lupus Activity Measure (SLAM) score

    1. Subjects with acute exacerbations of their disease, including hospitalized patients
    2. First-degree relatives of subjects with active disease
  • Subjects who have received or will receive a vaccination may be enrolled for bone marrow aspirates before and/or after vaccination. Vaccination will have been done by the subject's healthcare provider or through another outside source.
  • Subjects may have a screening blood draw performed in cases where a certain subset of cells or antibody titer is desired. This may be followed by additional blood draws and/or bone marrow aspiration after the ideal candidates have been identified.
  • Subjects who have been diagnosed with HIV or another infectious disease
  • Healthy controls must be free of acute or chronic disease at the time of bone marrow donation

Exclusion Criteria:

  • Poor venous access
  • Subjects who have had side effects to local anesthetics such as Lidocaine and who are on blood thinners such as warfarin
  • Normal controls must be free of acute or chronic diseases or medications that may affect the assay (as determined by the investigator).
  • Insufficient access to the iliac crest and bone is hindered. This generally correlates to a BMI (Body Mass Index) of greater than 25.0.

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): NCT02422875


Locations
United States, Georgia
Emory University Hospital (CIN/ACTSI)
Atlanta, Georgia, United States, 30322
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Ignatio Sanz, MD Emory University

Responsible Party: Ignacio Sanz, Professor, Emory University
ClinicalTrials.gov Identifier: NCT02422875     History of Changes
Other Study ID Numbers: IRB00058515
First Posted: April 21, 2015    Key Record Dates
Last Update Posted: August 2, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ignacio Sanz, Emory University:
Myositis
Inflammatory Arthritis
Sjögren's Syndrome
Scleroderma
Juvenile Idiopathic Arthritis
Rheumatoid Arthritis
Undifferentiated Connective Tissue Disease
Idiopathic thrombocytopenic purpura
Graft vs Host Disease
Autoimmune Lymphoproliferative Syndrome
Immunoglobulin G4 (IgG4)-related disease
Hepatitis C
Epstein Barr Virus (infectious mononucleosis - EBV)
Sepsis
Guillain-Barre syndrome
Mycoplasma pneumoniae
Human Immunodeficiency Virus

Additional relevant MeSH terms:
Autoimmune Diseases
Lupus Erythematosus, Systemic
Communicable Diseases
Infection
Immune System Diseases
Connective Tissue Diseases
Autoantibodies
Immunologic Factors
Physiological Effects of Drugs