NCT00379275

Brief Summary

This study will evaluate patients with sarcoidosis to understand how the disease affects the body. Sarcoidosis is a disease that results from inflammation of body tissues. The lungs, lymph nodes in the chest, skin and eyes are most commonly affected. As the disease progresses, small lumps, or granulomas, appear in the affected tissues. In most cases, the granulomas clear up, but in cases where they do not heal and disappear, the tissues tend to remain inflamed. Eye inflammation (uveitis) associated with sarcoidosis can cause various eye diseases, sometimes leading to blindness. This study will examine the clinical, immunological and genetic features of ocular sarcoidosis. Patients 6 years of age and older with sarcoidosis may be eligible for this study. Candidates are screened with the following procedures:

  • Completion of a questionnaire with medical, social and demographic information
  • Blood draw for laboratory tests
  • Complete eye examination, including measurement of eye pressure and dilation of the pupils to examine the back of the eye. Fluorescein angiography may be done. This test involves injecting a dye into a vein in the arm. The dye travels to the blood vessels in the eyes. A camera flashes a blue light into the eye and takes pictures of the retina that show whether the dye has leaked from the blood vessels into the retina. Other photographs of the eye may also be taken using a special camera. Participants are followed in conjunction with their local eye doctor as required by the status of their disease. Patients whose disease is stable are seen for an initial examination and followed every 12 months for 3 years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2006

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

September 18, 2006

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2006

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2007

Completed
Last Updated

July 2, 2017

Status Verified

December 10, 2007

First QC Date

September 20, 2006

Last Update Submit

June 30, 2017

Conditions

Keywords

SarcoidosisUveitisPulmonary SarcoidosisHLA-TypingCytokinesSerum Markers

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must be at least 6 years old
  • Participants must have biopsy-proven sarcoidosis
  • Participant must be able to consent to participating in the protocol
  • For minors, consent by an adult will be necessary

You may not qualify if:

  • We will exclude participants who are unable or unwilling to give blood at the designated times in the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • Jabs DA, Johns CJ. Ocular involvement in chronic sarcoidosis. Am J Ophthalmol. 1986 Sep 15;102(3):297-301. doi: 10.1016/0002-9394(86)90001-2.

    PMID: 3752193BACKGROUND

MeSH Terms

Conditions

SarcoidosisUveitisSarcoidosis, Pulmonary

Condition Hierarchy (Ancestors)

Lymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesHypersensitivity, DelayedHypersensitivityImmune System DiseasesUveal DiseasesEye DiseasesLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

September 20, 2006

First Posted

September 21, 2006

Study Start

September 18, 2006

Study Completion

December 10, 2007

Last Updated

July 2, 2017

Record last verified: 2007-12-10

Locations