Who may be eligible for the Comparative Autoantibody and Immunologic Cell Marker Study trial?

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 * 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. 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). * 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.

ClinicalTrials.gov record NCT02422875

Comparative Autoantibody and Immunologic Cell Marker Study

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

Comparative Autoantibody and Immunologic Cell Marker Study

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusEnrolling by invitationThe study enrols only people the study team invites, for example patients already at a particular clinic. It is not open to the public.

Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.

Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.

Age18 years old and older

SexAll

LocationUnited States

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is an observational case-control study comparing B lymphocytes from people with autoimmune diseases, people with certain infectious diseases, relatives of affected people, and healthy volunteers. Participation involves blood draws; some volunteers may also have a bone marrow aspirate. The study is cross-sectional with a short target duration (about 3 days of procedures).

What it is studying. The study tests how B cells differ in their development stage, function, and specificity — including autoreactivity — across people with autoimmune conditions, people with certain infections, and healthy controls. Researchers analyze cells from blood and, for some participants, bone marrow samples to map where autoreactive B cells are found.

What the researchers hope to learn. To describe the distribution, phenotype, and function of B cells — including autoreactive B cells — in bone marrow and blood across different groups. To compare immune-cell characteristics between autoimmune disease, infectious disease, relatives, and healthy volunteers to improve scientific understanding of autoimmune development.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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
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.

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).
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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants give blood samples (individual draws may be about 2/3 to ~9 tablespoons depending on tests). Blood draws will not occur more than twice a week and not exceed 16 tablespoons in one month. Some participants may undergo a bone marrow aspirate (about 3½ tablespoons taken with a large needle from the back of the hip); bone marrow donors may also be asked to give additional blood (up to 7 tablespoons) and may repeat marrow donation only after a minimum 8‑week interval. Samples will be used for laboratory analyses (for example, flow cytometry) and some people may have a screening blood draw to identify suitable candidates; vaccinated participants may have marrow sampling before and/or after vaccination.

How the study is structured. Observational, case-control, cross-sectional study. Participants provide blood samples and some provide a bone marrow aspirate; researchers compare immune cell features across predefined groups (autoimmune, infectious, relatives, healthy). No treatments are assigned.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
The registry says participants are enrolled by invitation. Who decides who is invited, and how?
The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

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Important dates

Study start: August 2012
Primary completion: May 2028 (estimated)
Study completion: May 2028 (estimated)
Target enrollment: 2500 participants (estimated)
Last updated on registry: Oct 1, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Emory University
Principal investigator: Ignacio Sanz, Professor
Emory University
Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)

Participating sites (3)

Emory University Hospital
Atlanta, Georgia, 30322 · United States
Emory University Winship Cancer Institute
Atlanta, Georgia, 30322 · United States
Grady Health System
Atlanta, Georgia, 30322 · United States

Terms used on this page · explanations by MedicalUpdates.ai

written informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
legal representative: A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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