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

July 13, 2020 updated by: Luca Cimino, Arcispedale Santa Maria Nuova-IRCCS

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The population will be composed of patients who come at the Simple Dipartiental Structure of Ocular Immunology of the Reggio Emilia Hospital with diagnosis of granulomatous uveiti and to whom are diagnosed a uveitis of tuberculous etiology or uveitis of suspect sarcoidosis or uveitis of undifferentiated origin (tuberculosis/sarcoidosis).

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Diagnostic test: 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.
Diagnostic test: 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.
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arcispedale Santa Maria Nuova-IRCCS

Investigators

  • Principal Investigator: Luca Cimino, IRCCS/AUSL Reggio Emilia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 3, 2017

Primary Completion (Anticipated)

August 30, 2021

Study Completion (Anticipated)

December 30, 2021

Study Registration Dates

First Submitted

November 15, 2017

First Submitted That Met QC Criteria

November 15, 2017

First Posted (Actual)

November 17, 2017

Study Record Updates

Last Update Posted (Actual)

July 14, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/0103969

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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