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 9, 2018
|Condition or disease|
|Autoimmune Diseases Lupus Erythematosus, Systemic Communicable Diseases|
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 :||1000 participants|
|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|
Subjects are healthy persons without any autoimmune conditions or infectious diseases
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
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
Subjects have received or will receive a vaccination as part of regular standard of care from their healthcare provider or other outside source
- Distribution of autoreactive B cells within bone marrow [ Time Frame: Baseline ]B cells will be analyzed using flow cytometry.
Biospecimen Retention: Samples With DNA
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
|United States, Georgia|
|Emory University Hospital (CIN/ACTSI)|
|Atlanta, Georgia, United States, 30322|
|Emory University Winship Cancer Institute|
|Atlanta, Georgia, United States, 30322|
|Principal Investigator:||Ignatio Sanz, MD||Emory University|