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Compares immune cells in people with lupus, infections, and healthy people

Compares B lymphocytes from people with autoimmune disease, infections, and healthy people.

Key facts

Who runs it
Emory University
Where
Atlanta, United StatesSee the 3 sites
Trial code
Registry title
Comparative Autoantibody and Immunologic Cell Marker Study
Status
Enrolling by invitation
People taking part
2,500 people, planned
Started
Aug 2012
Expected to end
May 2028
Type of study
Observational, 5 groups
Record updated
1 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with autoimmune diseases such as lupus, people with HIV or another infectious disease, and healthy controls. It studies their B cells (a type of immune cell).

Age
18 Years and older
Sex
All sexes can join
Disease stage
People with lupus (SLE) are not limited by treatment or disease activity, and may have incomplete lupus criteria (fewer than 4 items). People in a sudden flare of their disease, including those in hospital, can join.
Earlier treatment
People taking biologic or immune-modulating drugs for conditions such as cancer, allergy or lung disease can join. People who had a vaccination may give bone marrow samples before or after it.

Main reasons for not taking part

  • Poor venous access (hard to draw blood from a vein)
  • Past side effects to local anesthetics such as lidocaine, or taking blood thinners such as warfarin
  • Healthy controls with acute or chronic disease, or medicines that may affect the tests
  • Not enough access to the hip bone (iliac crest) for bone marrow donation
  • Pregnant or breastfeeding women cannot donate bone marrow

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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; Subjects with acute exacerbations of their disease, including hospitalized patients; 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
  • Subjects taking biologic and/or immune modulatory agents in diseases such as cancer, allergy, and pulmonary diseases will be enrolled
  • Healthy controls must be free of acute or chronic disease at the time of bone marrow donation. Healthy controls that are first-degree relatives of subjects with active disease will be enrolled as well

Who cannot take part

  • Normal controls must be free of acute or chronic diseases or medications that may affect the assay (as determined by the investigator)
  • Poor venous access
  • Subjects who have had side effects to local anesthetics such as lidocaine and who are on blood thinners such as warfarin
  • For subjects donating bone marrow, insufficient access to the iliac crest such that the periosteum and bone is hindered based on normal aspiration procedures
  • Pregnant or lactating women may not donate bone marrow

Where in United States

  • Emory University HospitalAtlanta, United StatesEnrolling by invitation
  • Emory University/Winship Cancer InstituteAtlanta, United StatesEnrolling by invitation
  • Grady Health SystemAtlanta, United StatesEnrolling by invitation

About the trial

What the trial wants to find out

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.

The 5 groups in the trial

  • 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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Comparative Autoantibody and Immunologic Cell Marker Study
Plain-language title
Compares immune cells in people with lupus, infections, and healthy peopleGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
1 October 2026