Subjects Clinically Suspected an Active Source of Toxoplasmosis Chorioretinitis Infection Clinical Trial
— BIOLUVEOfficial title:
Evaluation of Biological Biomarkers Diagnostic of Toxoplasmosis Uveitis
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.
| Status | Completed |
| Enrollment | 72 |
| Est. completion date | January 2016 |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 18 Years |
| Eligibility |
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 |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
| Country | Name | City | State |
|---|---|---|---|
| France | UniversityHospitalGrenoble | La Tronche |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Grenoble |
France,
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* Note: There are 22 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | ELISA tests | ELISA (enzyme linked immunosorbent assay) tests. Biological markers evaluation : stress protein Hsp70 and antibodies anti-Hsp70. | About an hour | No |