SarcoidosisNCT00379275
Eye and Immunogenetic Features of Sarcoidosis
An observational study of Sarcoidosis and Uveitis, run by National Eye Institute (NEI) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Sarcoidosis, Uveitis
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2006to 10 Dec 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- We will exclude participants who are unable or unwilling to give blood at the designated times in the protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Ocular and Immuno-Genetic Manifestations of Sarcoidosis
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:
Read more
- 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.
Read the detailed description
BACKGROUND
Sarcoidosis is a multi-systemic granulomatous disease. The lungs, thoracic lymph nodes, the skin and the eyes are the most commonly affected organs. Most patients with sarcoidosis present with respiratory symptoms. Sarcoid uveitis is usually suspected when ocular inflammation is found in conjunction with suggestive serological and radiological studies. Currently, the diagnosis of sarcoidosis requires the demonstration of non-caseating granulomas on biopsy; but even this is not always diagnostic; more sensitive and specific noninvasive tools are needed.
Ophthalmic involvement has been reported in as many as 40% of patients with sarcoidosis, but most series report ophthalmic findings in approximately 25% of patients who develop chronic, systemic sarcoidosis. Uveitis associated with sarcoidosis can be very diverse, including: acute non-granulomatous or chronic granulomatous iridocyclitis, vitritis, retinal vasculitis, choroiditis with choroidal granulomas and papillitis secondary to optic nerve granulomas; and it can cause ocular morbidity due to a high incidence of glaucoma and cataracts. Other ophthalmic findings include lacrimal gland enlargement, secondary Sjogren's disease, scleritis, orbital gland involvement, secondary proliferative retinopathy, subretinal neovascularization, and optic neuropathy.
To better evaluate and diagnose patients, we also need to improve our ability to predict susceptibility and prognosis, especially among African-Americans. Current epidemiologic studies of sarcoidosis indicate that in the United States, African Americans have about a threefold higher age-adjusted annual incidence, 35.5/100,000, compared with Caucasians, 10.9/100,000. In addition, African Americans with chronic sarcoidosis are more likely to develop ocular manifestations than whites. The study of ocular sarcoidosis is important because it is a leading inflammatory cause of blindness and ocular morbidity. In large surveys of patients with uveitis, approximately 5% of patients were found to have ocular sarcoidosis, and approximately 10% of these patients become blind in at least one eye.
AIMS:
AIM 1: CLINICAL ANALYSIS:
Documentation of:
- Clinical features of sarcoidosis associated uveitis
- Chronological association of ocular disease to histopathologic diagnosis of sarcoidos
- Family history of sarcoidosis
- Previous therapies and response
- Ocular status compared with systemic disease status, current and historical Environmental exposure history
AIM 2: IMMUNOLOGICAL ANALYSIS:
One of the goals of this study is to determine the diagnostically important cytokines in biopsy-proven ocular sarcoidosis.
The chemokine profile of the Peripheral Blood Mononuclear Cells and Broncho-Alveolar Lavage Fluid (BALF) of pulmonary sarcoidosis patients has been reported and many cytokines have been implicated in the pathogenesis of this disease.
- Serum Level for
- TNF alpha
- MIP-1 alpha
- IL-8
- IL-2
- TGF Beta
- INF gamma
- Immunophenotyping of whole blood cells and BALF by flow cytometry Focus on:
- T cell sub-typing (examples: CD4, CD8)
- NK cell sub-typing (examples:CD56, KIR)
- TLRs sub-typing
AIM 3: GENETIC ANALYSIS:
Serum analysis for HLA Class I and II typing
A cohort of 100 patients with biopsy-proven sarcoidosis will be recruited from the Uveitis and Ocular Immunology Clinic at the National Eye Institute and the Pulmonary Clinic at the National Heart Lung and Blood Institute.
FUTURE AIMS:
We aim to characterize the TLR activation profile in patients with ocular sarcoidosis, and compare them to patients with pulmonary sarcoidosis and normal volunteers. Using this immuno-genetic classification scheme, in conjunction with HLA typing, we hope to develop novel diagnostic and/or prognostic criteria for sarcoidosis. In addition, the TLR activation profile may allow risk stratification for different sarcoidosis phenotypes.
METHODS:
A cohort of 100 patients with biopsy-proven sarcoidosis will be recruited from the Uveitis and Ocular Immunology Clinic at the National Eye Institute and the Pulmonary Clinic at the National Heart Lung and Blood Institute. After obtaining informed consent, the patients will be invited to participate in the study. After appropriate enrollment, they will undergo the following
- Completion of a questionnaire, with medical, social and demographic data
- A complete ophthalmologic examination
- Baseline serologic analysis
- Baseline serum analysis for immunologic analysis
- HLA-Typing
- Patients who are quiescent will be seen at baseline with a second visit at 1 year
- Patients who are active will be treated appropriately, by their referring ophthalmologist or on a treatment protocol at the National Eye Institute
- Conditions
- Sarcoidosis, Uveitis
- Keywords
- Sarcoidosis, Uveitis, Pulmonary Sarcoidosis, HLA-Typing, Cytokines, Serum Markers
- Medical subject headings
- Sarcoidosis, Uveitis, Sarcoidosis, Pulmonary
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2006 (estimated)
- Study start18 Sep 2006
- Study completion10 Dec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SarcoidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379275
- Sponsor's protocol ID
- 060239
- Other IDs
- 06-EI-0239
- Status last verified
- 10 Dec 2007
- First submitted
- 20 Sep 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
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.
PubMed 3752193
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular and Immuno-Genetic Manifestations of Sarcoidosis
- ClinicalTrials.gov ID
- NCT00379275
- Acronym / sponsor ID
- 060239
- Conditions
- Sarcoidosis, Uveitis
- Keywords
- Sarcoidosis, Uveitis, Pulmonary Sarcoidosis, HLA-Typing, Cytokines, Serum Markers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 18 Sep 2006
- Study completion
- 10 Dec 2007
- First posted
- 21 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
BACKGROUND
Sarcoidosis is a multi-systemic granulomatous disease. The lungs, thoracic lymph nodes, the skin and the eyes are the most commonly affected organs. Most patients with sarcoidosis present with respiratory symptoms. Sarcoid uveitis is usually suspected when ocular inflammation is found in conjunction with suggestive serological and radiological studies. Currently, the diagnosis of sarcoidosis requires the demonstration of non-caseating granulomas on biopsy; but even this is not always diagnostic; more sensitive and specific noninvasive tools are needed.
Ophthalmic involvement has been reported in as many as 40% of patients with sarcoidosis, but most series report ophthalmic findings in approximately 25% of patients who develop chronic, systemic sarcoidosis. Uveitis associated with sarcoidosis can be very diverse, including: acute non-granulomatous or chronic granulomatous iridocyclitis, vitritis, retinal vasculitis, choroiditis with choroidal granulomas and papillitis secondary to optic nerve granulomas; and it can cause ocular morbidity due to a high incidence of glaucoma and cataracts. Other ophthalmic findings include lacrimal gland enlargement, secondary Sjogren's disease, scleritis, orbital gland involvement, secondary proliferative retinopathy, subretinal neovascularization, and optic neuropathy.
To better evaluate and diagnose patients, we also need to improve our ability to predict susceptibility and prognosis, especially among African-Americans. Current epidemiologic studies of sarcoidosis indicate that in the United States, African Americans have about a threefold higher age-adjusted annual incidence, 35.5/100,000, compared with Caucasians, 10.9/100,000. In addition, African Americans with chronic sarcoidosis are more likely to develop ocular manifestations than whites. The study of ocular sarcoidosis is important because it is a leading inflammatory cause of blindness and ocular morbidity. In large surveys of patients with uveitis, approximately 5% of patients were found to have ocular sarcoidosis, and approximately 10% of these patients become blind in at least one eye.
AIMS:
AIM 1: CLINICAL ANALYSIS:
Documentation of:
- Clinical features of sarcoidosis associated uveitis
- Chronological association of ocular disease to histopathologic diagnosis of sarcoidos
- Family history of sarcoidosis
- Previous therapies and response
- Ocular status compared with systemic disease status, current and historical Environmental exposure history
AIM 2: IMMUNOLOGICAL ANALYSIS:
One of the goals of this study is to determine the diagnostically important cytokines in biopsy-proven ocular sarcoidosis.
The chemokine profile of the Peripheral Blood Mononuclear Cells and Broncho-Alveolar Lavage Fluid (BALF) of pulmonary sarcoidosis patients has been reported and many cytokines have been implicated in the pathogenesis of this disease.
- Serum Level for
- TNF alpha
- MIP-1 alpha
- IL-8
- IL-2
- TGF Beta
- INF gamma
- Immunophenotyping of whole blood cells and BALF by flow cytometry Focus on:
- T cell sub-typing (examples: CD4, CD8)
- NK cell sub-typing (examples:CD56, KIR)
- TLRs sub-typing
AIM 3: GENETIC ANALYSIS:
Serum analysis for HLA Class I and II typing
A cohort of 100 patients with biopsy-proven sarcoidosis will be recruited from the Uveitis and Ocular Immunology Clinic at the National Eye Institute and the Pulmonary Clinic at the National Heart Lung and Blood Institute.
FUTURE AIMS:
We aim to characterize the TLR activation profile in patients with ocular sarcoidosis, and compare them to patients with pulmonary sarcoidosis and normal volunteers. Using this immuno-genetic classification scheme, in conjunction with HLA typing, we hope to develop novel diagnostic and/or prognostic criteria for sarcoidosis. In addition, the TLR activation profile may allow risk stratification for different sarcoidosis phenotypes.
METHODS:
A cohort of 100 patients with biopsy-proven sarcoidosis will be recruited from the Uveitis and Ocular Immunology Clinic at the National Eye Institute and the Pulmonary Clinic at the National Heart Lung and Blood Institute. After obtaining informed consent, the patients will be invited to participate in the study. After appropriate enrollment, they will undergo the following
- Completion of a questionnaire, with medical, social and demographic data
- A complete ophthalmologic examination
- Baseline serologic analysis
- Baseline serum analysis for immunologic analysis
- HLA-Typing
- Patients who are quiescent will be seen at baseline with a second visit at 1 year
- Patients who are active will be treated appropriately, by their referring ophthalmologist or on a treatment protocol at the National Eye Institute
Study design
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (1 listed)
- We will exclude participants who are unable or unwilling to give blood at the designated times in the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 3752193Jabs 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcoidosis and Uveitis, run by National Eye Institute (NEI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00379275, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.