Subjects Clinically Suspected an Active Source of Toxoplasmosis Chorioretinitis InfectionBIOLUVENCT02843438
Evaluation of Biological Biomarkers Diagnostic of Toxoplasmosis Uveitis
A study testing Fluorescein angiography, Dilated fundus examination and Toxoplasmosis serology in people with Subjects Clinically Suspected an Active Source of Toxoplasmosis Chorioretinitis Infection, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Subjects Clinically Suspected an Active Source of Toxoplasmosis Chorioretinitis Infection
- What is being tested?
- Fluorescein angiography, Dilated fundus examination and Toxoplasmosis serology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2010to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age over 18 years
- Subjects clinically suspected at least of one active source of toxoplasmosis chorioretinitis infection
- Persons affiliated to national social security
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Being tested
- Fluorescein angiography, Dilated fundus examination, Toxoplasmosis serology, Anti-toxoplasmosis treatment, Anti-inflammatory treatments
- Keywords
- Toxoplasmosis, Uveitis, Chorioretinitis, Infection
- Medical subject headings
- Toxoplasmosis, Uveitis, Chorioretinitis, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescein angiographyOther
Dilated fundus examinationOther
Toxoplasmosis serologyBiological
Anti-toxoplasmosis treatmentDrug
Anti-inflammatory treatmentsDrug
Puncture in anterior chamberOther
| Study group | Role | What they receive |
|---|---|---|
| Subjects suspected of toxoplasmosis chorioretinitis infection | Other | Subjects clinically suspected at least of one active source of toxoplasmosis chorioretinitis infection Receives: 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 being measured
The primary outcome is the main question the study is designed to answer.
ELISA tests
ELISA (enzyme linked immunosorbent assay) tests. Biological markers evaluation : stress protein Hsp70 and antibodies anti-Hsp70.
Measured: About an hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2016 (estimated)
- Study startJan 2010
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Subjects Clinically Suspected an Active Source of Toxoplasmosis Chorioretinitis InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurence Bouillet, Professor, Principal investigator, Grenoble Hospital University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02843438
- Sponsor's protocol ID
- 38RC09.014
- Acronym
- BIOLUVE
- Status last verified
- Jul 2016
- First submitted
- 21 Jul 2016
- Last updated
- 25 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Bonfioli AA, Orefice F. Toxoplasmosis. Semin Ophthalmol. 2005 Jul-Sep;20(3):129-41. doi: 10.1080/08820530500231961.
PubMed 16282146Bouillet 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.
PubMed 10880922Brenier-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.
PubMed 17645187Chen 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.
PubMed 12502724Chumpitazi 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.
PubMed 7650171Chumpitazi 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.
PubMed 18696130Delair 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.
PubMed 18723143Derouin 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.
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.
PubMed 5924940Direskeneli 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.
PubMed 14727460Echeverria 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.
PubMed 15967463Fang 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.
PubMed 16943259Holland GN. Reconsidering the pathogenesis of ocular toxoplasmosis. Am J Ophthalmol. 1999 Oct;128(4):502-5. doi: 10.1016/s0002-9394(99)00263-9.
PubMed 10577593Imamura 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.
PubMed 15654837Kodjikian 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.
PubMed 15906073
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Biological Biomarkers Diagnostic of Toxoplasmosis Uveitis
- ClinicalTrials.gov ID
- NCT02843438
- Acronym / sponsor ID
- BIOLUVE / 38RC09.014
- Keywords
- Toxoplasmosis, Uveitis, Chorioretinitis, Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 25 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects suspected of toxoplasmosis chorioretinitis infection | Other | Other: Fluorescein angiography, Other: Dilated fundus examination, Biological: Toxoplasmosis serology, Drug: Anti-toxoplasmosis treatment, Drug: Anti-inflammatory treatments, Other: Puncture in anterior chamberSubjects clinically suspected at least of one active source of toxoplasmosis chorioretinitis infection |
Who may qualify
- Ages
- Up to 18 years
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age over 18 years
- Subjects clinically suspected at least of one active source of toxoplasmosis chorioretinitis infection
- Persons affiliated to national social security
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 |
Primary outcome
ELISA tests
Time frame: About an hour
ELISA (enzyme linked immunosorbent assay) tests. Biological markers evaluation : stress protein Hsp70 and antibodies anti-Hsp70.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2016.
- Background: PubMed 16282146Bonfioli AA, Orefice F. Toxoplasmosis. Semin Ophthalmol. 2005 Jul-Sep;20(3):129-41. doi: 10.1080/08820530500231961.
- Background: PubMed 10880922Bouillet 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.
- Background: PubMed 17645187Brenier-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.
- Background: PubMed 12502724Chen 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.
- Background: PubMed 7650171Chumpitazi 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.
- Background: PubMed 18696130Chumpitazi 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.
- Background: PubMed 18723143Delair 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.
- BackgroundDerouin 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: PubMed 5924940Desmonts G. Definitive serological diagnosis of ocular toxoplasmosis. Arch Ophthalmol. 1966 Dec;76(6):839-51. doi: 10.1001/archopht.1966.03850010841012. No abstract available.
- Background: PubMed 14727460Direskeneli 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.
- Background: PubMed 15967463Echeverria 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.
- Background: PubMed 16943259Fang 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurence Bouillet, Professor principal investigator
Grenoble Hospital University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluorescein angiography, Dilated fundus examination and Toxoplasmosis serology in people with Subjects Clinically Suspected an Active Source of Toxoplasmosis Chorioretinitis Infection, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ELISA tests (time frame: About an hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02843438, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2016.