NCT00001278

Brief Summary

The purpose of this study is to develop a relatively simple, accurate method of diagnosing sarcoidosis. Sarcoidosis is a disease in which granulomas (nodules of inflamed tissue) develop in various organs, such as the lungs, liver, skin and eyes. Disease symptoms vary depending on the tissues involved. Many patients develop uveitis (eye inflammation). Tissue biopsy-often a costly and difficult invasive procedure-is currently the only definitive diagnostic test for sarcoidosis. Other tests, such as blood and urine tests, do not provide definitive results. Patients with uveitis that is 1) known to be due to sarcoidosis; 2) suspected to be due to sarcoidosis based on specific diagnostic criteria; and 3) known not to be due to sarcoidosis may be enrolled in this study. Participants will undergo an eye examination, blood tests, chest X-ray, and skin test for tuberculosis and other infections. Small tissue samples from the conjunctiva (the thin lining covering the outside of the eye and the inside of the eyelid) and the lacrimal (tear) gland will be taken after the eye is numbed with anesthetic drops and injection. Investigators will examine and compare levels of certain proteins in the biopsied tissues from the three patient groups to see if elevated levels of these substances may indicate granuloma formation. Development of a new, relatively simple diagnostic test for sarcoidosis based on these findings may permit doctors to start appropriate therapy earlier in the course of disease without invasive biopsy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 1991

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1991

Completed
8.5 years until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2001

Completed
1.7 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

May 1, 2000

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

Keywords

Conjunctival BiopsyLacrimal Gland BiopsySarcoid UveitisSarcoidosisConjunctivaInflammatory Eye Disease

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Biopsy proven sarcoidosis with intraocular inflammatory eye disease.
  • Intraocular inflammatory eye disease with suspected sarcoidosis based on age, race and characteristic granulomatous intraocular inflammation.
  • Inflammatory eye disease of a known etiology other than sarcoidosis.
  • Age greater than 18 years.
  • Can not have known bleeding diathesis, ocular infection, known allergy to local anesthetic agent or current treatment with a monoamine oxidase inhibitor, or vision worse than 20/400 in either eye.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Eye Institute (NEI)

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

  • Chan CC, Wetzig RP, Palestine AG, Kuwabara T, Nusenblatt RB. Immunohistopathology of ocular sarcoidosis. Report of a case and discussion of immunopathogenesis. Arch Ophthalmol. 1987 Oct;105(10):1398-402. doi: 10.1001/archopht.1987.01060100100036.

    PMID: 3478042BACKGROUND
  • Moller DR, Konishi K, Kirby M, Balbi B, Crystal RG. Bias toward use of a specific T cell receptor beta-chain variable region in a subgroup of individuals with sarcoidosis. J Clin Invest. 1988 Oct;82(4):1183-91. doi: 10.1172/JCI113715.

    PMID: 2459159BACKGROUND

MeSH Terms

Conditions

Sarcoidosis

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

May 1, 1991

Study Completion

April 1, 2001

Last Updated

March 4, 2008

Record last verified: 2000-05

Locations