Evaluation of Biological Biomarkers Diagnostic of Toxoplasmosis Uveitis

NCT02843438 | Completed

• 1 other identifier: 38RC09.014
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Subjects Clinically Suspected an Active Source of Toxoplasmosis Chorioretinitis Infection

Keywords

Toxoplasmosis; Uveitis; Chorioretinitis; Infection

Outcome Measures

Primary Outcomes (1)

• ELISA tests

  ELISA (enzyme linked immunosorbent assay) tests. Biological markers evaluation : stress protein Hsp70 and antibodies anti-Hsp70.

  About an hour

Study Arms (1)

Subjects suspected of toxoplasmosis chorioretinitis infection

OTHER

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

Interventions

Fluorescein angiography OTHER

Subjects suspected of toxoplasmosis chorioretinitis infection

Dilated fundus examination OTHER

Subjects suspected of toxoplasmosis chorioretinitis infection

Toxoplasmosis serology BIOLOGICAL

Subjects suspected of toxoplasmosis chorioretinitis infection

Anti-toxoplasmosis treatment DRUG

Subjects suspected of toxoplasmosis chorioretinitis infection

Anti-inflammatory treatments DRUG

Subjects suspected of toxoplasmosis chorioretinitis infection

Puncture in anterior chamber OTHER

Subjects suspected of toxoplasmosis chorioretinitis infection

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Grenoble: lead

Study Sites (1)

UniversityHospitalGrenoble

La Tronche, 38700, France

Location

Related Publications (22)

• Bonfioli AA, Orefice F. Toxoplasmosis. Semin Ophthalmol. 2005 Jul-Sep;20(3):129-41. doi: 10.1080/08820530500231961.

  PMID: 16282146 BACKGROUND

• Bouillet L, Sarrot-Reynauld F, Gonzalvez B, Massot C, Romanet J, Mouillon M. [Diagnostic strategy in uveitis: a prospective study in 125 cases]. J Fr Ophtalmol. 2000 Jun;23(6):569-75. French.

  PMID: 10880922 BACKGROUND

• Brenier-Pinchart MP, Morand-Bui V, Fricker-Hidalgo H, Equy V, Marlu R, Pelloux H. Adapting a conventional PCR assay for Toxoplasma gondii detection to real-time quantitative PCR including a competitive internal control. Parasite. 2007 Jun;14(2):149-54. doi: 10.1051/parasite/2007142149.

  PMID: 17645187 BACKGROUND

• Chen M, Aosai F, Norose K, Mun HS, Yano A. The role of anti-HSP70 autoantibody-forming V(H)1-J(H)1 B-1 cells in Toxoplasma gondii-infected mice. Int Immunol. 2003 Jan;15(1):39-47. doi: 10.1093/intimm/dxg004.

  PMID: 12502724 BACKGROUND

• Chumpitazi BF, Boussaid A, Pelloux H, Racinet C, Bost M, Goullier-Fleuret A. Diagnosis of congenital toxoplasmosis by immunoblotting and relationship with other methods. J Clin Microbiol. 1995 Jun;33(6):1479-85. doi: 10.1128/jcm.33.6.1479-1485.1995.

  PMID: 7650171 BACKGROUND

• Chumpitazi BF, Bouillet L, Drouet MT, Kuhn L, Garin J, Zarski JP, Drouet C. Biological autoimmunity screening in hepatitis C patients by anti-HepG2 lysate and anti-heat shock protein 70.1 autoantibodies. Eur J Clin Microbiol Infect Dis. 2009 Feb;28(2):137-46. doi: 10.1007/s10096-008-0599-y. Epub 2008 Aug 12.

  PMID: 18696130 BACKGROUND

• Delair E, Monnet D, Grabar S, Dupouy-Camet J, Yera H, Brezin AP. Respective roles of acquired and congenital infections in presumed ocular toxoplasmosis. Am J Ophthalmol. 2008 Dec;146(6):851-5. doi: 10.1016/j.ajo.2008.06.027. Epub 2008 Aug 23.

  PMID: 18723143 BACKGROUND

• Derouin F, Bultel C, Roze S. (Coordination rédactionnelle). Toxoplasmose: état des connaissances et évaluation du risque lié à l'alimentation. Rapport du groupe de travail " Toxoplasma gondii " de l'Afssa. Coordination éditoriale : Thomann C & Ribeiro F. AFSSA Déc. 2005, pp318.

  BACKGROUND

• Desmonts G. Definitive serological diagnosis of ocular toxoplasmosis. Arch Ophthalmol. 1966 Dec;76(6):839-51. doi: 10.1001/archopht.1966.03850010841012. No abstract available.

  PMID: 5924940 BACKGROUND

• Direskeneli H, Saruhan-Direskeneli G. The role of heat shock proteins in Behcet's disease. Clin Exp Rheumatol. 2003 Jul-Aug;21(4 Suppl 30):S44-8.

  PMID: 14727460 BACKGROUND

• Echeverria PC, Matrajt M, Harb OS, Zappia MP, Costas MA, Roos DS, Dubremetz JF, Angel SO. Toxoplasma gondii Hsp90 is a potential drug target whose expression and subcellular localization are developmentally regulated. J Mol Biol. 2005 Jul 22;350(4):723-34. doi: 10.1016/j.jmb.2005.05.031.

  PMID: 15967463 BACKGROUND

• Fang H, Aosai F, Mun HS, Norose K, Ahmed AK, Furuya M, Yano A. Anaphylactic reaction induced by Toxoplasma gondii-derived heat shock protein 70. Int Immunol. 2006 Oct;18(10):1487-97. doi: 10.1093/intimm/dxl081. Epub 2006 Aug 30.

  PMID: 16943259 BACKGROUND

• Holland GN. Reconsidering the pathogenesis of ocular toxoplasmosis. Am J Ophthalmol. 1999 Oct;128(4):502-5. doi: 10.1016/s0002-9394(99)00263-9.

  PMID: 10577593 BACKGROUND

• Imamura Y, Kurokawa MS, Yoshikawa H, Nara K, Takada E, Masuda C, Tsukikawa S, Ozaki S, Matsuda T, Suzuki N. Involvement of Th1 cells and heat shock protein 60 in the pathogenesis of intestinal Behcet's disease. Clin Exp Immunol. 2005 Feb;139(2):371-8. doi: 10.1111/j.1365-2249.2005.02695.x.

  PMID: 15654837 BACKGROUND

• Kodjikian L, Wallon M, Fleury J, Denis P, Binquet C, Peyron F, Garweg JG. Ocular manifestations in congenital toxoplasmosis. Graefes Arch Clin Exp Ophthalmol. 2006 Jan;244(1):14-21. doi: 10.1007/s00417-005-1164-3. Epub 2005 May 20.

  PMID: 15906073 BACKGROUND

• Lyons RE, Johnson AM. Heat shock proteins of Toxoplasma gondii. Parasite Immunol. 1995 Jul;17(7):353-9. doi: 10.1111/j.1365-3024.1995.tb00902.x.

  PMID: 8552407 BACKGROUND

• Maubon D, Ajzenberg D, Brenier-Pinchart MP, Darde ML, Pelloux H. What are the respective host and parasite contributions to toxoplasmosis? Trends Parasitol. 2008 Jul;24(7):299-303. doi: 10.1016/j.pt.2008.03.012. Epub 2008 May 29.

  PMID: 18514029 BACKGROUND

• Pelloux H, Mouillon M, Romanet JP, Reynier P, Ligeon P, Goullier-Fleuret A, Ambroise-Thomas P. [Ocular toxoplasmosis. Comparison between two biological methods to study aqueous humor]. Presse Med. 1991 Oct 26;20(34):1655-8. French.

  PMID: 1836568 BACKGROUND

• Quintana FJ, Cohen IR. Heat shock proteins as endogenous adjuvants in sterile and septic inflammation. J Immunol. 2005 Sep 1;175(5):2777-82. doi: 10.4049/jimmunol.175.5.2777.

  PMID: 16116161 BACKGROUND

• SenGupta D, Norris PJ, Suscovich TJ, Hassan-Zahraee M, Moffett HF, Trocha A, Draenert R, Goulder PJ, Binder RJ, Levey DL, Walker BD, Srivastava PK, Brander C. Heat shock protein-mediated cross-presentation of exogenous HIV antigen on HLA class I and class II. J Immunol. 2004 Aug 1;173(3):1987-93. doi: 10.4049/jimmunol.173.3.1987.

  PMID: 15265933 BACKGROUND

• Silva NM, Gazzinelli RT, Silva DA, Ferro EA, Kasper LH, Mineo JR. Expression of Toxoplasma gondii-specific heat shock protein 70 during In vivo conversion of bradyzoites to tachyzoites. Infect Immun. 1998 Aug;66(8):3959-63. doi: 10.1128/IAI.66.8.3959-3963.1998.

  PMID: 9673286 BACKGROUND

• Wang XH, Qin Y, Hu MH, Xie Y. Dendritic cells pulsed with gp96-peptide complexes derived from human hepatocellular carcinoma (HCC) induce specific cytotoxic T lymphocytes. Cancer Immunol Immunother. 2005 Oct;54(10):971-80. doi: 10.1007/s00262-005-0662-9. Epub 2005 Jun 18.

  PMID: 15965645 BACKGROUND

MeSH Terms

Conditions

Toxoplasmosis; Uveitis; Chorioretinitis; Infections

Interventions

Punctures

Condition Hierarchy (Ancestors)

Coccidiosis; Protozoan Infections; Parasitic Diseases; Uveal Diseases; Eye Diseases; Retinitis; Retinal Diseases; Choroiditis; Choroid Diseases; Uveitis, Posterior; Panuveitis

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative

Study Officials

• Laurence Bouillet, Professor

  Grenoble Hospital University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2016
• First Posted: July 25, 2016
• Study Start: January 1, 2010
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: July 25, 2016

Record last verified: 2016-07

Locations

FR (1)