Completed

NCT Number: NCT03346018

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

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.

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Key information

Conditions

Uveitis Tuberculous Uveitis Sarcoid

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS/AUSL Reggio Emilia Hospital

Reggio Emilia, 42123, Italy

About this study

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:

Determination of the concentration of various cytokines, chemokines and growth factors in aqueous humor and in the plasma.
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.
Evaluation of the presence of anti-human HSP70 antibodies in plasma samples by Western blot immunoprecipitation assays.
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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Analysis of aqueous humor and plasma samples

Diagnostic Test

The collected samples will be analyzed as follow:

Determination of the concentration of various cytokines, chemokines and groeth factors in aqueous humor and in the plasma.
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.
Evaluation of the presence of anti-human HSP70 antibodies in plasma samples by Western blot immunoprecipitation assays.
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.

Primary outcomes

Identify, in the aqueous humor and in the blood of patients suffering from granulomatous uveitis the presence of immunologic markers that distinguish between uveitis of tuberculous etiology and uveitis by sarcoidosis

Time frame: 3 days

The statistical analysis will based on the use of non parametric test between Group (Mann Whitney)

Sponsors and collaborators

Lead sponsor

Azienda USL Reggio Emilia - IRCCS

Other Gov

Registry information

Official study title

Observational Study: Definition of Immunologic Markers for the Differential Diagnosis Between Uveitis From Supposed Tuberculous Etiology and Sarcoidosis Uveitis

Acronym: TBC-SARC

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2022
First posted: Nov 17, 2017
Registry last updated: Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.