Immunologic Markers for the Differential Diagnosis Between Uveitis-TBC and Uveitis-SARC (TBC-SARC)

NCT ID: NCT03346018

Last Updated: 2025-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-03

Study Completion Date

2022-12-30

Brief Summary

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Today there are no tests that allow to make a precise differential diagnosis between uveitis from presumed tuberculous origin and uveitis by sarcoidosis. Therefore, with this study, investigators aim to identify, in the aqueous humor and in the blood of participants (patients that suffering from one of these two forms of uveitis) the presence of immunologic markers that distinguish between uveitis of tuberculous etiology and uveitis by sarcoidosis.

Detailed Description

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Both tuberculosis and sarcoidosis are chronic, multi-systemic and granulomatous pathologies that have very similar pulmonary and extra-pulmonary manifestations, and even in the case of ocular involvement it has been shown that many features of intraocular TB can also be found in participants with ocular sarcoidosis.

In this monocentric observational study investigators are asking to the participants with granulomatous uveitis, in which a tuberculosis or sarcoidosis origin is suspected and who will have undergo paracentesis of the anterior chamber, to grant part of the aqueous humor and a blood sample for this study.

The collected samples will be analyzed as follow:

1. Determination of the concentration of various cytokines, chemokines and growth factors in aqueous humor and in the plasma.
2. Analysis of the mononuclear cells ( T helper lymphocytes CD3+ (CD3 is the acronym of cluster of differentiation 3: a glycoprotein found on the surface of immune cells) and CD4+ ((CD4 is the acronym of cluster of differentiation 4), T cytotoxic lymphocytes CD3+ CD8+ (CD8 is the acronym of cluster of differentiation 8) , B lymphocytes CD19+ (CD19 is the acronym of cluster of differentiation 19), Natural killer lymphocytes CD56+ (CD56 is the acronym of cluster of differentiation 56) and CD3- and monocytes CD14+ (CD14 is the acronym of cluster of differentiation 14) present in the aqueous humor by cytofluorimetry.
3. Evaluation of the presence of anti-human HSP70 antibodies in plasma samples by Western blot immunoprecipitation assays.
4. Whenever possible (adequate number of cells), in vitro stimulation of mononuclear cells in aqueous humor with epitopes of tuberculosis mycobacterium antigens and the analysis of cytokines production in the supernatants.

Conditions

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Uveitis Tuberculous Uveitis Sarcoid

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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uveitis of tuberculous etiology

Analysis of aqueous humor and plasma samples: The patients with diagnosis of uveitis of tuberculous etiology, undergone to paracentesis of anterior chamber, will can able to grant their aqueous humor and a sample of venous blood to the study of immunological markers to distinguish between uveitis of tuberculous etiology from uveitis by sarcoidosis through the analysis of the aqueous humor and the analysis of the plasma samples.

Analysis of aqueous humor and plasma samples

Intervention Type DIAGNOSTIC_TEST

The collected samples will be analyzed as follow:

1. Determination of the concentration of various cytokines, chemokines and groeth factors in aqueous humor and in the plasma.
2. Analysis of the mononuclear cells ( T helper lymphocytes CD3+ and CD4+, T cytotoxic lymphocytes CD3+ CD8+, B lymphocytes CD19+, Natural killer lymphocytes CD56+ and CD3- and monocytes CD14+) present in the aqueous humor by cytofluorimetry.
3. Evaluation of the presence of anti-human HSP70 antibodies in plasma samples by Western blot immunoprecipitation assays.
4. Whenever possible (adequate number of cells), in vitro stimulation of mononuclear cells presence in aqueous humor with epitopes from tuberculosis mycobacterium antigens and the analysis of cytokines production in the supernatants.

uveitis of suspect sarcoidosis

Analysis of aqueous humor and plasma samples:The patients with diagnosis of uveitis of suspect sarcoidosis, undergone to paracentesis of anterior chamber, will can able to grant their aqueous humor and a sample of venous blood to the study of immunological markers to distinguish between uveitis of tuberculous etiology from uveitis by sarcoidosis through the analysis of the aqueous humor and the analysis of the plasma samples.

Analysis of aqueous humor and plasma samples

Intervention Type DIAGNOSTIC_TEST

The collected samples will be analyzed as follow:

1. Determination of the concentration of various cytokines, chemokines and groeth factors in aqueous humor and in the plasma.
2. Analysis of the mononuclear cells ( T helper lymphocytes CD3+ and CD4+, T cytotoxic lymphocytes CD3+ CD8+, B lymphocytes CD19+, Natural killer lymphocytes CD56+ and CD3- and monocytes CD14+) present in the aqueous humor by cytofluorimetry.
3. Evaluation of the presence of anti-human HSP70 antibodies in plasma samples by Western blot immunoprecipitation assays.
4. Whenever possible (adequate number of cells), in vitro stimulation of mononuclear cells presence in aqueous humor with epitopes from tuberculosis mycobacterium antigens and the analysis of cytokines production in the supernatants.

uveitis of undifferentiated origin

Analysis of aqueous humor and plasma samples:The patients with diagnosis of uveitis of undifferentiated origin (tuberculosis/sarcoidosis), undergone to paracentesis of anterior chamber, will can able to grant their aqueous humor and a sample of venous blood to the study of immunological markers to distinguish between uveitis of tuberculous etiology from uveitis by sarcoidosis through the analysis of the aqueous humor and the analysis of the plasma samples.

Analysis of aqueous humor and plasma samples

Intervention Type DIAGNOSTIC_TEST

The collected samples will be analyzed as follow:

1. Determination of the concentration of various cytokines, chemokines and groeth factors in aqueous humor and in the plasma.
2. Analysis of the mononuclear cells ( T helper lymphocytes CD3+ and CD4+, T cytotoxic lymphocytes CD3+ CD8+, B lymphocytes CD19+, Natural killer lymphocytes CD56+ and CD3- and monocytes CD14+) present in the aqueous humor by cytofluorimetry.
3. Evaluation of the presence of anti-human HSP70 antibodies in plasma samples by Western blot immunoprecipitation assays.
4. Whenever possible (adequate number of cells), in vitro stimulation of mononuclear cells presence in aqueous humor with epitopes from tuberculosis mycobacterium antigens and the analysis of cytokines production in the supernatants.

Interventions

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Analysis of aqueous humor and plasma samples

The collected samples will be analyzed as follow:

1. Determination of the concentration of various cytokines, chemokines and groeth factors in aqueous humor and in the plasma.
2. Analysis of the mononuclear cells ( T helper lymphocytes CD3+ and CD4+, T cytotoxic lymphocytes CD3+ CD8+, B lymphocytes CD19+, Natural killer lymphocytes CD56+ and CD3- and monocytes CD14+) present in the aqueous humor by cytofluorimetry.
3. Evaluation of the presence of anti-human HSP70 antibodies in plasma samples by Western blot immunoprecipitation assays.
4. Whenever possible (adequate number of cells), in vitro stimulation of mononuclear cells presence in aqueous humor with epitopes from tuberculosis mycobacterium antigens and the analysis of cytokines production in the supernatants.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Patients with diagnosis of uveitis of tuberculous etiology or patients with diagnosis of uveitis of suspect sarcoidosis or patients with diagnosis of uveitis of undifferentiated origin (tuberculosis/sarcoidosis)

Exclusion Criteria

* Patients suffering from non-granulomatous uveitis.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Azienda USL Reggio Emilia - IRCCS

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Luca Cimino

Role: PRINCIPAL_INVESTIGATOR

IRCCS/AUSL Reggio Emilia

Locations

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IRCCS/AUSL Reggio Emilia Hospital

Reggio Emilia, Reggio Emilia, Italy

Site Status

Countries

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Italy

Other Identifiers

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2017/0103969

Identifier Type: -

Identifier Source: org_study_id

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