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Determination of Genetic Susceptibility in Severe Recurrences of Ocular Toxoplasmosis (TREXO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02863588
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : August 21, 2019
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief Summary:
Ocular toxoplasmosis (OT) is a major cause of visual impairment worldwide. OT is responsible for 30 to 50% of posterior uveitis. It is characterized by dormant infections that may reactivate without known reasons, causing severe irreversible visual loss. The overall recurrence rate of OT in Europe is greater than 80% for patients and may range from one episode to 11 episodes (1% of OT) in the most extreme cases. Current treatments do not reduce the risk of recurrences and the risk of toxoplasmosis recurrence cannot be predicted in these immunocompetent patients. These clinical and biological expression changes might be related to an individual genetic susceptibility of each patient. The advanced analysis of the entire genome now possible to consider the project.

Condition or disease Intervention/treatment Phase
Toxoplasmosis Infection Genotype II Ocular Toxoplasmosis With Recurrences Biological: seropositive for Toxoplasma gondii Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Determination of Genetic Susceptibility in Severe Recurrences of Ocular Toxoplasmosis
Actual Study Start Date : March 30, 2017
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Toxoplasmosis

Arm Intervention/treatment
Experimental: seropositive for Toxoplasma gondii Biological: seropositive for Toxoplasma gondii
blood sample

Primary Outcome Measures :
  1. Highlighting of genetic mutations associated with the susceptibility to Toxoplasma gondii.severe eye recurrences. Mutation analysis will be done by exome sequencing of the subjects included in this study [ Time Frame: This analysis will be performed on a blood sample taken in patients included in the inclusion visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • seropositive for Toxoplasma gondii (for patient and parents)
  • Infection with genotype II (for patient and parents)
  • ocular toxoplasmosis recurrences >5 (patients only)

Exclusion Criteria:

  • Parents seronegative for T. gondii infection
  • Infection with others genotypes than type II

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02863588

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Contact: Arnaud SAUER, MD 03 69 55 13 13 ext 0033

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University Hospital, Strasbourg, france Recruiting
Strasbourg, France, 67000
Contact: Arnaud Sauer, MD   
Sponsors and Collaborators
University Hospital, Strasbourg, France
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Principal Investigator: Arnaud SAUER, MD University Hospital, Strasbourg, France

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Responsible Party: University Hospital, Strasbourg, France Identifier: NCT02863588     History of Changes
Other Study ID Numbers: 6433
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Toxoplasmosis, Ocular
Genetic Predisposition to Disease
Disease Attributes
Pathologic Processes
Disease Susceptibility
Protozoan Infections
Parasitic Diseases
Eye Infections, Parasitic
Eye Infections
Eye Diseases