Immunologic Markers for the Differential Diagnosis Between Uveitis-TBC and Uveitis-SARC (TBC-SARC)
NCT ID: NCT03346018
Last Updated: 2025-06-11
Study Results
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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COMPLETED
31 participants
OBSERVATIONAL
2017-11-03
2022-12-30
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
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
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
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
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
90 Years
ALL
Yes
Sponsors
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Azienda USL Reggio Emilia - IRCCS
OTHER_GOV
Responsible Party
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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
Countries
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Other Identifiers
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2017/0103969
Identifier Type: -
Identifier Source: org_study_id
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