Paraneoplastic Neurological SyndromeIFINEURONCT05783947
Diagnostic Performance of a Commercial Assay for the Detection of Neuronal Antibodies
An observational study of Paraneoplastic Neurological Syndrome and Autoimmune Encephalitis, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
Detection of autoantibodies targeting neuronal surface or intracellular antigens is a keystone for the diagnosis and the treatment of auto-immune encephalitis and paraneoplastic neurological syndromes. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Paraneoplastic Neurological Syndrome, Autoimmune Encephalitis
- What is being tested?
- Indirect immunofluorescence assay on tissue slides and cell-based assays with CSF and/or sera
- How many people
- 34 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Mar 2021to 28 Feb 2022
- 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 with a suspicion of autoimmune encephalitis or paraneoplastic neurological syndrome
- Inclusion Criteria * : Sera and/or CSF with sufficient volume to perform both in-house and commercial assays
- Exclusion Criteria * : Sera and/or CSF with insufficient volume to perform both in-house and commercial assays
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hospice Civils de Lyon
Bron, 69500,
Hospices Civils de Lyon
Pierre-Bénite
About this study
Official title: Diagnostic Performance of a Commercial Indirect Immunofluorescence Assay for the Detection of Neuronal Antibodies in Auto-immune Encephalitis and Paraneoplastic Neurological Syndromes
Detection of autoantibodies targeting neuronal surface or intracellular antigens is a keystone for the diagnosis and the treatment of auto-immune encephalitis and paraneoplastic neurological syndromes. A strategy commonly used for their detection is to perform a screening with a tissue-based immunofluorescence assay or immunohistochemistry assay and a second line test to confirm and identify the autoantibody. Since several years, commercial kits are used by a growing number of laboratories to screen the presence of these autoantibodies. However, the diagnostic performance of these commercial kits is highly variable and several studies reported a high prevalence of false-positive and false-negative results with commercial immunodots and cell-based assays. It is therefore essential to explore commercial kits limitations in order to avoid false-positive and false-negative results that could lead to misdiagnosis and/or to delay the treatments.
To assess the diagnostic performance of commercial kits, the investigators performed a prospective study in which the investigators screened patients neuronal autoantibodies in cerebrospinal fluid and sera using commercial tissue-based indirect immunofluorescence assay and CBAs in comparison with an in-house tissue-based indirect immunofluorescence assay.
- Being tested
- Indirect immunofluorescence assay on tissue slides and cell-based assays with CSF and/or sera
- Keywords
- autoantibodies, diagnostic, paraneoplastic, encephalitis, neuronal
- Medical subject headings
- Autoimmune Diseases of the Nervous System, Disease, Encephalitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirect immunofluorescence assay on tissue slides and cell-based assays with CSF and/or seraDiagnostic test
Sera and/or CSF samples are drawn from patients with a clinical suspicion of autoimmune encephalitis or paraneoplastic neurological syndrome. Indirect immunofluorescence assays will be performed on commercial and in-house slides upon receipt in our center. In case of positive staining, additional tests such as cell-based assays, western-blots, ELISA or immunodots can be performed.
| Study group | Role | What they receive |
|---|---|---|
| Suspicion of autoimmune neurological disorder | Sera and CSF of patients with a suspicion of autoimmune encephalitis or paraneoplastic neurological syndrome Receives: Diagnostic Test: Indirect immunofluorescence assay on tissue slides and cell-based assays with CSF and/or sera |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of discrepant results between commercial and in-house assays
Both in-house and commercial assays will be performed independently and results will be compared once all tests are done. Number of discrepant results will be compared with concordant results according to the autoantibody identified.
Measured: at the baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2023
- Study start1 Mar 2021
- Primary completion15 Jul 2021
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paraneoplastic Neurological SyndromeStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérome HONNORAT, PhD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05783947
- Sponsor's protocol ID
- 23-5024
- Acronym
- IFINEURO
- Status last verified
- Mar 2023
- First submitted
- 13 Mar 2023
- Last updated
- 24 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Performance of a Commercial Indirect Immunofluorescence Assay for the Detection of Neuronal Antibodies in Auto-immune Encephalitis and Paraneoplastic Neurological Syndromes
- ClinicalTrials.gov ID
- NCT05783947
- Acronym / sponsor ID
- IFINEURO / 23-5024
- Keywords
- autoantibodies, diagnostic, paraneoplastic, encephalitis, neuronal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 24 Mar 2023 (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.
Detection of autoantibodies targeting neuronal surface or intracellular antigens is a keystone for the diagnosis and the treatment of auto-immune encephalitis and paraneoplastic neurological syndromes. A strategy commonly used for their detection is to perform a screening with a tissue-based immunofluorescence assay or immunohistochemistry assay and a second line test to confirm and identify the autoantibody. Since several years, commercial kits are used by a growing number of laboratories to screen the presence of these autoantibodies. However, the diagnostic performance of these commercial kits is highly variable and several studies reported a high prevalence of false-positive and false-negative results with commercial immunodots and cell-based assays. It is therefore essential to explore commercial kits limitations in order to avoid false-positive and false-negative results that could lead to misdiagnosis and/or to delay the treatments.
To assess the diagnostic performance of commercial kits, the investigators performed a prospective study in which the investigators screened patients neuronal autoantibodies in cerebrospinal fluid and sera using commercial tissue-based indirect immunofluorescence assay and CBAs in comparison with an in-house tissue-based indirect immunofluorescence assay.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspicion of autoimmune neurological disorder | – | Diagnostic Test: Indirect immunofluorescence assay on tissue slides and cell-based assays with CSF and/or seraSera and CSF of patients with a suspicion of autoimmune encephalitis or paraneoplastic neurological syndrome |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a suspicion of autoimmune encephalitis or paraneoplastic neurological syndrome
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 |
|---|---|---|
| Indirect immunofluorescence assay on tissue slides and cell-based assays with CSF and/or seraSera and/or CSF samples are drawn from patients with a clinical suspicion of autoimmune encephalitis or paraneoplastic neurological syndrome. Indirect immunofluorescence assays will be performed on commercial and in-house slides upon receipt in our center. In case of positive staining, additional tests such as cell-based assays, western-blots, ELISA or immunodots can be performed. | Diagnostic test | Suspicion of autoimmune neurological disorder |
Primary outcome
Number of discrepant results between commercial and in-house assays
Time frame: at the baseline
Both in-house and commercial assays will be performed independently and results will be compared once all tests are done. Number of discrepant results will be compared with concordant results according to the autoantibody identified.
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 24 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Jérome HONNORAT, PhD principal investigator
Hospices Civils de Lyon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paraneoplastic Neurological Syndrome and Autoimmune Encephalitis, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Number of discrepant results between commercial and in-house assays (time frame: at the baseline). 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 24 Mar 2023.