Paraneoplastic Neurological SyndromeDeNobioNCT05728931
New Biomarkers in Auto-immune Encephalitis and Neurological Paraneoplastic Syndromes
An observational study of Paraneoplastic Neurological Syndrome and Autoimmune Encephalitis, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Autoimmune encephalitis (AE) and paraneoplastic neurological syndromes (PNS) are rare neuroimmune syndromes with a wide range of clinical presentation but without pathognomonic clinical sign facilitating the diagnosis. A lot of differential diagnoses are possible such as neurodegenerative diseases or viral infections. 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?
- Test of biological samples
- How many people
- 210 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jan 2022to 15 Jan 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Patient without antibodies known with neurological disorder and include in biobank of "centre de reference des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes".
Who may be able to join
- patient with neurological disorder
- patient without antibody
Who cannot join
- patient with characterized antibody
- patient without neurological disorder
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes
Lyon, 69677
About this study
Autoimmune encephalitis (AE) and paraneoplastic neurological syndromes (PNS) are rare neuroimmune syndromes with a wide range of clinical presentation but without pathognomonic clinical sign facilitating the diagnosis. A lot of differential diagnoses are possible such as neurodegenerative diseases or viral infections. Although rare the diagnosis of AE or PNS is essential because despite severe neurological symptoms, patients can be cured by appropriate immunotherapy. Autoantibodies highly specific of AE and PNS has been described in the serum and cerebrospinal fluid of the patients and can be used as biomarkers of the disease. Their presence can predict an autoimmune origin and in many cases a good prognosis after immunotherapy. However, if some autoantibodies are now well-characterized and industrial kits have been developed to detect them, in numerous cases of highly suspect AE or PNS no specific autoantibodies are identified leading frequently to an inappropriate treatment. Furthermore, as the mechanisms of AE and PNS is still unknown, treatments are not optimal and in some cases inefficient. There is no prognosis biomarker able to predict the patient's sensitivity to immunotherapy and there are only few clues to know how the immune system can provoke the neuropsychiatric symptoms observed in the patients. The investigators will use this project to better characterize AE and PNS patients to identify new diagnostic and prognostic biomarkers and develop new diagnostic tools.
- Being tested
- Test of biological samples
- Keywords
- Paraneoplastic Neurological Syndrome, Autoimmune Encephalitis
- Medical subject headings
- Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Test of biological samplesBiological
Different tests can be use on biological sample : western bloc, dot blot, immune-fluorescence, immunoprecipitation, CBA, functional test, epitope research, IgG title
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of new biomarkers
Results of diagnostics tests for each patient, description of marking
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start15 Jan 2022
- Primary completion15 Jan 2026 (estimated)
- Study completion15 Jan 2032 (estimated)
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
- Other
- Time perspective
- Retrospective
- Enrolment
- 210 participants (estimated)
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
- NCT05728931
- Sponsor's protocol ID
- 748
- Acronym
- DeNobio
- Status last verified
- Feb 2023
- First submitted
- 21 Nov 2022
- Last updated
- 15 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Biomarkers in Auto-immune Encephalitis and Neurological Paraneoplastic Syndromes
- ClinicalTrials.gov ID
- NCT05728931
- Acronym / sponsor ID
- DeNobio / 748
- Keywords
- Paraneoplastic Neurological Syndrome, Autoimmune Encephalitis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Jan 2022 (actual)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 15 Jan 2032 (estimated)
- First posted
- 15 Feb 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.
Autoimmune encephalitis (AE) and paraneoplastic neurological syndromes (PNS) are rare neuroimmune syndromes with a wide range of clinical presentation but without pathognomonic clinical sign facilitating the diagnosis. A lot of differential diagnoses are possible such as neurodegenerative diseases or viral infections. Although rare the diagnosis of AE or PNS is essential because despite severe neurological symptoms, patients can be cured by appropriate immunotherapy. Autoantibodies highly specific of AE and PNS has been described in the serum and cerebrospinal fluid of the patients and can be used as biomarkers of the disease. Their presence can predict an autoimmune origin and in many cases a good prognosis after immunotherapy. However, if some autoantibodies are now well-characterized and industrial kits have been developed to detect them, in numerous cases of highly suspect AE or PNS no specific autoantibodies are identified leading frequently to an inappropriate treatment. Furthermore, as the mechanisms of AE and PNS is still unknown, treatments are not optimal and in some cases inefficient. There is no prognosis biomarker able to predict the patient's sensitivity to immunotherapy and there are only few clues to know how the immune system can provoke the neuropsychiatric symptoms observed in the patients. The investigators will use this project to better characterize AE and PNS patients to identify new diagnostic and prognostic biomarkers and develop new diagnostic tools.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient without antibodies known with neurological disorder and include in biobank of "centre de reference des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes".
Key inclusion criteria (2 listed)
Key exclusion criteria (2 listed)
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 |
|---|---|---|
| Test of biological samplesDifferent tests can be use on biological sample : western bloc, dot blot, immune-fluorescence, immunoprecipitation, CBA, functional test, epitope research, IgG title | Biological | – |
Primary outcome
Description of new biomarkers
Time frame: Baseline
Results of diagnostics tests for each patient, description of marking
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Characterization of Immune-response in Autoimmune Encephalitis and Paraneoplastic Neurological Syndromes
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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.
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 Paraneoplastic Neurological Syndrome and Autoimmune Encephalitis, 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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 15 Feb 2023. 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?
This study is still under way. Results are not available in the source record yet.
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?
Description of new biomarkers (time frame: 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 15 Feb 2023; AzTrials last refreshed its copy on 8 Nov 2026.