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

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ClinicalTrials.gov Identifier: NCT02863588
Recruitment Status : Recruiting
First Posted : August 11, 2016
Last Update Posted : August 21, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Tracking Information
First Submitted Date  ICMJE August 8, 2016
First Posted Date  ICMJE August 11, 2016
Last Update Posted Date August 21, 2019
Actual Study Start Date  ICMJE March 30, 2017
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2016)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02863588 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Determination of Genetic Susceptibility in Severe Recurrences of Ocular Toxoplasmosis
Official Title  ICMJE Determination of Genetic Susceptibility in Severe Recurrences of Ocular Toxoplasmosis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE
  • Toxoplasmosis Infection
  • Genotype II
  • Ocular Toxoplasmosis With Recurrences
Intervention  ICMJE Biological: seropositive for Toxoplasma gondii
blood sample
Study Arms  ICMJE Experimental: seropositive for Toxoplasma gondii
Intervention: Biological: seropositive for Toxoplasma gondii
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 8, 2016)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Arnaud SAUER, MD 03 69 55 13 13 ext 0033 arnaud.sauer@chru-strasbourg.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02863588
Other Study ID Numbers  ICMJE 6433
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Strasbourg, France
Study Sponsor  ICMJE University Hospital, Strasbourg, France
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arnaud SAUER, MD University Hospital, Strasbourg, France
PRS Account University Hospital, Strasbourg, France
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP