Comparative Autoantibody and Immunologic Cell Marker Study

Official record

Identifier

NCT02422875

Recruiting locations

country

United States

Interventions studied

Not provided in the official record

Lead sponsor

Emory University

Target enrolment

2500 participants

Study type

OBSERVATIONAL

Phase

Not provided in the official record

Status

Enrolling by invitation

First posted

Apr 21, 2015

Last updated on the registry

Oct 1, 2026

Age

18 Years

Sex

ALL

Study contact

No public contact is listed on the official record.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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.

Indexed under

Liver Cancer