Immunogenetic Mechanisms in Behcet's Disease

NCT01109433 | Terminated

• 2 other identifiers: 10009310-EI-0093
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Background: \- Uveitis, the inflammation of the interior of the eye, is responsible for numerous new cases of legal blindness every year. Uveitis can be caused by Beh(SqrRoot)(Beta)et s disease (BD), a chronic inflammatory disorder that can affect the eye, mucous membranes, and other body organs such as the joints, intestinal tract, blood vessels, and central nervous system. Objectives: The purpose of this study is to see how genes affect Beh(SqrRoot)(Beta)et s disease and if there are differences in Beh(SqrRoot)(Beta)et s disease among people of different backgrounds. Eligibility:

• Individuals who have a diagnosis of BD and are enrolled in another NIH study.
• Individuals who are willing to donate blood for the purposes of this research study and who are willing to have their blood stored for possible future/other research purposes. Design:
• As part of the study, blood samples will be drawn from participants when an exacerbation in disease activity occurs and before and after any significant change in treatment for BD.
• No treatments will be provided in this study.

Conditions

Behcet's Disease; Uveitis

Keywords

Behcet's Disease; Intermediate Uveitis; Uveitis; Immunogenetics

Outcome Measures

Primary Outcomes (1)

• Establishing evidence for serum biomarkers associated with BD and establishing demethylation differences between ocular and non-ocular BD participants and controls.

  Ongoing

Secondary Outcomes (1)

• To explore associations between disease severity and treatment response with observed epigenetic modifications and biomarkers.

  Ongoing

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• One of the following must be true:
• Participants must have a diagnosis of BD according to the International Study Group for BD criteria or modified Japanese criteria, be enrolled in another NIH study and be willing to donate their blood for the purposes of this research study.
• Participants must be willing to have their blood stored for future/other research.

You may not qualify if:

• Eligible participants who do not wish to donate their blood sample or undergo a blood draw for the purposes of this research study.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Gritz DC, Wong IG. Incidence and prevalence of uveitis in Northern California; the Northern California Epidemiology of Uveitis Study. Ophthalmology. 2004 Mar;111(3):491-500; discussion 500. doi: 10.1016/j.ophtha.2003.06.014.

  PMID: 15019324 BACKGROUND

• Chamberlain MA. Behcet's syndrome in 32 patients in Yorkshire. Ann Rheum Dis. 1977 Dec;36(6):491-99. doi: 10.1136/ard.36.6.491.

  PMID: 596943 BACKGROUND

• Jankowski J, Crombie I, Jankowski R. Behcet's syndrome in Scotland. Postgrad Med J. 1992 Jul;68(801):566-70. doi: 10.1136/pgmj.68.801.566.

  PMID: 1437955 BACKGROUND

MeSH Terms

Conditions

Behcet Syndrome; Uveitis; Uveitis, Intermediate

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Uveitis, Anterior; Panuveitis; Uveal Diseases; Eye Diseases; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vascular

Study Officials

• Hatice N Sen, M.D.

  National Eye Institute (NEI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2010
• First Posted: April 23, 2010
• Study Start: April 15, 2010
• Study Completion: December 17, 2018
• Last Updated: November 4, 2019

Record last verified: 2018-12-17

Locations

US (1)