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Research/Clinical Trials

Biomarkers Study

Center for Biomarker Research Study of Behçet’s Disease

Behçet’s Disease (BD) is a chronic, multisystem inflammatory disease which occurs in genetically susceptible individuals as a result of poorly understood environmental challenges. These environmental challenges may include infectious agents, environmental toxins, or other unknown entities which appear to cause a harmful and recurrent inflammatory reaction by the patient’s immune system. The inflammatory reaction often results in recurrent genital ulcers, skin lesions, uveitis1, as well as inflammation in large vessels, the central nervous system, and the gastrointestinal tract. Unfortunately, Behçet’s Disease takes years to diagnose and has unpredictable remissions and relapses throughout a patient’s life. The disease is rare in the United States, ~5 cases /100,000, but is more prevalent in the Eastern Mediterranean countries. Onset usually occurs between the ages of 15 and 45 with equal distribution between men and women, and progresses as a series of remissions and relapses. Currently there are no biomarker tests for BD and diagnosis is based on clinical manifestations which are quite varied and not specific for BD. Without biomarkers, remissions and relapses, which occur over the lifetime of the patient, cannot be effectively monitored. This study is designed to develop specific diagnostic tests to help patients and the medical community better manage the disease. Research in better diagnostic biomarkers for rare diseases, which are often difficult to diagnose, is limited by the availability of patient samples. Keck Graduate Institute of Applied Life Sciences (KGI) and the American Behçet’s Disease Association (ABDA) are using social networking to obtain samples directly from patients in order to identify differences in serum proteins between BD patients and controls. ABDA obtains signed informed consent forms, under the Center for Biomarker Research (CBR) approved IRB, from patients interested in participating in this study. ABDA then acts as the firewall between CBR and patient participants. Patients simply ask for an extra tube of serum and whole blood during their normal blood draw and the samples are shipped overnight to CBR. Patient and normal serum are labeled with different tags, mixed and analyzed by gel electrophoresis. Bands that show differential migration will be further analyzed to identify the exact protein present in each band. Based on these findings, immunoassays, which are more precise, rapid and quantitative than gel electrophoresis, will be developed and used in clinical trials to validate their effectiveness as biomarkers to better manage patients with BD.

 

NIH Clinical Trials  

The U.S. National Institutes of Health (NIH) has created a free registry and results database of publicly and privately supported clinical studies of human participants conducted around the world. Click on the link below to be redirected. Once you've arrived at the NIH page, enter Behcet's Disease (or any disease) on the red "Search for Studies" section to access the clinical trials results. http://clinicaltrials.gov

_________________________________________________________________________________________________Clinical Research study of an investigational drug for oral ulcers associated with Behcet's Disease now recruiting. Learn more at: https://studypages.com/celgene/relief-study-behcets/


 "Identification and Characterization of Rare Disease Biomarkers focusing on Behcet's Disease"  View more by clicking on the link:  BEHCET'S DISEASE STUDY STATUS REPORT 2012FINAL(2).PDF

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