Evaluation of Biological Biomarkers Diagnostic of Toxoplasmosis Uveitis (BIOLUVE)

July 22, 2016 updated by: University Hospital, Grenoble

Toxoplasmosis affects one to two newborn each 10000 births. Among them, 1 to 2 % develop learning disabilities or die, and 4 to 27 % develop a chorioretinitis sometimes leading to an amblyopia responsible for visual impairment. Toxoplasmosis uveitis affects too adults immunocompetent and immunodepressed who have had an acquired toxoplasmosis. Clinical diagnosis of ocular toxoplasmosis is more complicated in presence of posterior neuro-retinitis, inflammation of the papilla, uveitis without chorioretinitis, fuchs heterochromic iridocyclitis, scleritis, diffuse necrotizing or multifocal retinitis. In this situation biological markers diagnostic and prognostic of toxoplasmosis uveitis are useful.

Highly kept molecules (during evolution) like stress proteins (Hsp) are are found in the host and the pathogen and there can trigger a crossed immune response. Stress proteins haven't been explored yet, in the context of toxoplasmosis uveitis on humans.

The hypothesis is that Hsp70 and antibodies anti-Hsp70 are diagnostic and prognostic markers of ocular toxoplasmosis.

The goal is to evaluate diagnosis value of biological markers (Hsp70 and antibodies IgG anti-Hsp70) in toxoplasmosis uveitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • France
      • La Tronche, France, 38700
        • UniversityHospitalGrenoble

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

No older than 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age over 18 years
  • Subjects clinically suspected at least of one active source of toxoplasmosis chorioretinitis infection
  • Persons affiliated to national social security

Exclusion Criteria:

  • Pregnant, parturient or breastfeeding women
  • Persons deprived of liberty by judicial or administrative decision, person under legal protection
  • Refusal by a patient to do the PCA (anterior chamber puncture)
  • Patients whose following will be difficult or nonexistent

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

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Subjects suspected of toxoplasmosis chorioretinitis infection
Subjects clinically suspected at least of one active source of toxoplasmosis chorioretinitis infection
Other: Fluorescein angiography
Other: Dilated fundus examination
Biological: Toxoplasmosis serology
Drug: Anti-toxoplasmosis treatment
Drug: Anti-inflammatory treatments
Other: Puncture in anterior chamber

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ELISA tests
Time Frame: About an hour
ELISA (enzyme linked immunosorbent assay) tests. Biological markers evaluation : stress protein Hsp70 and antibodies anti-Hsp70.
About an hour

Collaborators and Investigators

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

Sponsor

University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2010

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

July 21, 2016

First Submitted That Met QC Criteria

July 22, 2016

First Posted (Estimate)

July 25, 2016

Study Record Updates

Last Update Posted (Estimate)

July 25, 2016

Last Update Submitted That Met QC Criteria

July 22, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC09.014

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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