Dallas Regional Autoimmune Disease Registry

Study ID
STU 042011-135

Cancer Related

Healthy Volunteers

Study Sites

  • Parkland Health & Hospital System
  • UT Southwestern Ambulatory Services

Azza Badr

Principal Investigator
David Karp, M.D., Ph.D.


The establishment of this registry for subjects with rheumatic diseases will accomplish several goals.First, it will serve as a mechanism to provide informative samples via peripheral blood, urine and/or buccal swabs to researchers in the Simmons arthritis Research Center and Rheumatic Diseases Division.These samples will be used to test the hypothesis that the cellular, proteomic and gene expression profiles of subjects with established autoimmune disease is different from healthy controls or subjects with early disease. These experiments rely on sophisticated analytical techniques now available at uT Southwestern.This includes proteomic studies that determine the level and type of autoantibodies and other important proteins in blood.Transcriptomic studies quantify the level of messenger and micro Rna in cells and tissues.Metabolomic assays use mass spectroscopy to measure the amounts of chemicals in body fluids.Genomic studies look at the variation in Dna sequences.This ranges from determining general levels of genetic variation by single nucleotide polymorphism typing, to sequencing of portions of or the whole genome of individuals.This [Quote]omics[Quote] approach is designed to provide a total picture of the immune system function in healthy and affected individuals. By creating a registry/repository that oversees a number of categories of experiments ranging from minimal risk blood tests to more complicated genetic studies, the registry can provide integral ethical and regulatory oversight; allowing investigators the ability to innovate new techniques and studies while respecting the rights and confidentiality of participants.

While patients could be asked to donate samples without the establishment of a registry, this mechanism will provide an infrastructure that centralizes recruitment, standardizes contact with subjects, and keeps track of which patients have been studied.This will be more efficient for investigators and convenient for subjects. it will also minimize the inadvertent disclosure of personal information during the conduct of research by separating sample collection from sample or data analysis. This will ensure effective compliance with institutional regulations and policies, State and Federal laws, and the Privacy Rule authorized by the Health insurance Portability and accountability act (HiPaa) of 1996 (45 CFR 164).Specifically, covered health care entities would be assured that subjects had given written informed consent to allow their protected health information (PHi) to be disclosed to the registry as part of an iRB approved protocol. Research records of PHi maintained in the registry database would also be subject to terms of the Privacy Rule preventing disclosure to other individuals or entities without the subject's consent.

The genomic Dna, serum and urine repository maintained by the registry will serve as a valuable research resource. as candidate genes are identified, stored Dna samples can be screened for polymorphic markers.Such studies could further mechanistic studies, lead to the development of genetic testing, or open new avenues of therapy.Lack of such a repository would require re-contacting subjects at later dates unnecessarily.

This project is not merely a specimen repository.Samples will be analyzed for protein content (e.g., cytokines, immunoglobulin), for cellular makeup, for gene expression patterns, and for variation in genes involved in the immune response.Such derived data will be analyzed by registry investigators and stored along with clinical and epidemiological data.

Finally, the organization of this registry will serve as a means to inform potential subjects and their physicians about the possibility of participating in this type of clinical research.By seeking participants from a wide geographic distribution (north Texas region), it will shorten the time to conduct the research supported by the registry and improve the statistical power of the data collected.

Participant Eligibility

Criteria for Inclusion of Subjects:

1. Health status: Persons with autoimmune diseases as well as healthy controls (including unaffected family members) can participate in this registry. The primary focus will be on patients with systemic lupus erythematosus, rheumatoid arthritis, ankylosing Spondylitis, allergic asthma, and multiple sclerosis. Subjects with other conditions such as Sj[?]gren[Single Quote]s syndrome, inflammatory myopathy, vasculitis, psoriatic arthritis, reactive arthritis, gout, sarcoidosis, osteoarthritis, and fibromyalgia may also be included.
2. Age: Persons of any age can participate in this registry. Participation of children with autoimmune disease is extremely important and will be emphasized where possible. All research involving children will be conducted in accordance with the regulations contained in 45 CFR 46, Subpart D.
3. Gender: Men and women, including pregnant women, will be eligible for this registry. Due to the nature of the illnesses under study, it is anticipated that mild to marked deviation from the general population ratio of women to men will occur.
4. Ethnicity: Persons of all ethnic groups will be encouraged to participate in this registry.
5. Relationship to proband: Some studies supported by this registry will need family members of affected individuals. These family members could either be healthy or affected themselves, depending on the study.
6. Availability for follow-up: All participants will be asked for permission to be contacted at a future date for additional samples or data. Refusal to grant such permission will not disqualify the subject from participation in the registry. All future contact with subjects will be initiated from the Principal Investigator[Single Quote]s office to maintain confidentiality.
7. Ability to speak and read English: In general, subjects will be recruited for the registry regardless of their English fluency. Some studies will require reading and answering questionnaires. Subjects may not qualify for those studies if they cannot read English and the study instruments are not available in a validated format in their native language.
8. Ability to give informed consent: All subjects (or their parents or legal guardians) must be able to give consent to enter the registry.