Ocular ToxoplasmosisCOPILOTNCT03948750
Immunoblotting and Goldmann-Witmer Coefficient for Ocular Toxoplasmosis
An observational study of Ocular Toxoplasmosis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Ocular toxoplasmosis (OT) is a common cause of posterior uveitis worldwide. The diagnosis of OT is based on clinical findings, but in most cases, laboratory tests are required to confirm the etiology, especially when other diseases are suspected. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ocular Toxoplasmosis
- What is being tested?
- Aqueous humour sampling
- Type of treatment
- Surgery or procedure
- How many people
- 87 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2010to 31 May 2014
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who had underwent aqueous humor and serum sample for ocular toxoplasmosis
Who may be able to join
- Patients who had underwent aqueous humor and serum sample for ocular toxoplasmosis diagnosis
Who cannot join
- Immunocompromised patients
Trial locations and contacts
1 site in 1 country.
France1 site
Service d'ophtalmologie, Hôpital de la Croix-Rousse (HCL)
Lyon, 69004
About this study
Official title: Comparison of Immunoblotting (IgA and IgG) and the Goldmann-Witmer Coefficient for Diagnosis of Ocular Toxoplasmosis in Immunocompetent Patients
Ocular toxoplasmosis (OT) is a common cause of posterior uveitis worldwide. The diagnosis of OT is based on clinical findings, but in most cases, laboratory tests are required to confirm the etiology, especially when other diseases are suspected. The aim of this study was to evaluate which methods, between the Goldmann-Witmer coefficient (GWC) and immunoblotting (IB) with both IgG and IgA, in aqueous humour (AH) samples, can be the most sensitive to diagnose OT, in current practice, especially in the first three weeks.
Read the detailed description
Goldmann-Witmer coefficient (GWC): compares the levels of intraocular antibody (igG) production to that serum, as measured by ELISA.
GWC = (Level of specific IgG in aqueous humour/level of specific IgG in serum)/(Total IgG in aqueous humour/Total IgG in serum)
0.5 to 2: No intraocular antibody production, 2 to 4: Suggestive of intraocular antibody production, > 4: Diagnostic of intraocular antibody production to a specific microbial pathogen
- Conditions
- Ocular Toxoplasmosis
- Being tested
- Aqueous humour sampling
- Medical subject headings
- Toxoplasmosis, Ocular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aqueous humour samplingProcedure or surgery
Aqueous humour sampling with Goldman-Witmer coefficient and immunoblotting
| Study group | Role | What they receive |
|---|---|---|
| Patients with Ocular Toxoplasmosis | Not described Receives: Procedure: Aqueous humour sampling | |
| Patients without Ocular Toxoplasmosis | Not described Receives: Procedure: Aqueous humour sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Goldmann-Witmer coefficient and immunoblotting results
All tests realized in patients were performed before their repartition in the two groups as well as the biologist could not know the status of the patient. Sensitivity and specificity were calculated for each test.
Measured: Assessment of each test result at the inclusion of the patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2019
- Study start1 Jan 2010
- Primary completion31 May 2014
- Study completion31 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular ToxoplasmosisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03948750
- Sponsor's protocol ID
- COPILOT
- Acronym
- COPILOT
- Status last verified
- May 2019
- First submitted
- 10 May 2019
- Last updated
- 14 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Immunoblotting (IgA and IgG) and the Goldmann-Witmer Coefficient for Diagnosis of Ocular Toxoplasmosis in Immunocompetent Patients
- ClinicalTrials.gov ID
- NCT03948750
- Acronym / sponsor ID
- COPILOT / COPILOT
- Conditions
- Ocular Toxoplasmosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 May 2014 (actual)
- Study completion
- 31 May 2014 (actual)
- First posted
- 14 May 2019 (actual)
- 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.
Ocular toxoplasmosis (OT) is a common cause of posterior uveitis worldwide. The diagnosis of OT is based on clinical findings, but in most cases, laboratory tests are required to confirm the etiology, especially when other diseases are suspected. The aim of this study was to evaluate which methods, between the Goldmann-Witmer coefficient (GWC) and immunoblotting (IB) with both IgG and IgA, in aqueous humour (AH) samples, can be the most sensitive to diagnose OT, in current practice, especially in the first three weeks.
Detailed description
Goldmann-Witmer coefficient (GWC): compares the levels of intraocular antibody (igG) production to that serum, as measured by ELISA.
GWC = (Level of specific IgG in aqueous humour/level of specific IgG in serum)/(Total IgG in aqueous humour/Total IgG in serum)
0.5 to 2: No intraocular antibody production, 2 to 4: Suggestive of intraocular antibody production, > 4: Diagnostic of intraocular antibody production to a specific microbial pathogen
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with Ocular Toxoplasmosis | – | Procedure: Aqueous humour sampling |
| Patients without Ocular Toxoplasmosis | – | Procedure: Aqueous humour sampling |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who had underwent aqueous humor and serum sample for ocular toxoplasmosis
Key inclusion criteria (1 listed)
- Patients who had underwent aqueous humor and serum sample for ocular toxoplasmosis diagnosis
Key exclusion criteria (1 listed)
- Immunocompromised patients
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 |
|---|---|---|
| Aqueous humour samplingAqueous humour sampling with Goldman-Witmer coefficient and immunoblotting | Procedure or surgery | Patients with Ocular Toxoplasmosis, Patients without Ocular Toxoplasmosis |
Primary outcome
Comparison of Goldmann-Witmer coefficient and immunoblotting results
Time frame: Assessment of each test result at the inclusion of the patient
All tests realized in patients were performed before their repartition in the two groups as well as the biologist could not know the status of the patient. Sensitivity and specificity were calculated for each test.
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 14 May 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ocular Toxoplasmosis, run by Hospices Civils de Lyon 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 1 inclusion and 1 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 14 May 2019. 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?
Comparison of Goldmann-Witmer coefficient and immunoblotting results (time frame: Assessment of each test result at the inclusion of the patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 May 2019.