Neurological Diseases or ConditionsNeuro-GFAPNCT05742087
Neuropathy and Anti-GFAP Antibodies
An observational study of Neurological Diseases or Conditions and Neurological Diseases Associated to Anti GFAP Antibodies, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Anti-Glial Fibrillary Acidic Protein (GFAP) are antibodies associated to inflammatory diseases of the central nervous system. The GFAP protein is highly expressed by astrocytes explaining these syndromes, but GFAP is also expressed by immature and non-myelinating Schwann cells. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurological Diseases or Conditions, Neurological Diseases Associated to Anti GFAP Antibodies
- What is being tested?
- Clinical examination and electroneuromyography (ENMG)
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2022to 1 May 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 120 patients presenting with neurological symptoms and with identified anti-GFAP antibodies in the CSF, included in the French cohort of patients with neurological syndroms and anti-GFAP antibodies identified in the cerebrospinal fluid (CSF) of the "Centre de reference des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes", will be studied.
Who may be able to join
- - Age > 18 years old
- Neurological symptoms
- Anti-GFAP antibodies identified in the CSF
Who cannot join
- - Uncomplete data in the medical records of patients
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
Official title: Study of the Consequences of Anti-GFAP Antibodies on the Peripheral Nervous System
Anti-Glial Fibrillary Acidic Protein (GFAP) are antibodies associated to inflammatory diseases of the central nervous system. The GFAP protein is highly expressed by astrocytes explaining these syndromes, but GFAP is also expressed by immature and non-myelinating Schwann cells. Thus, these antibodies could also lead to damages of the peripheral nervous system (PNS). Moreover, such damages have already been reported on small studies, and there is a need for larger cohorts.
The investigators will use the cohort of patients with neurological syndromes and anti-GFAP antibodies identified in the cerebrospinal fluid (CSF) of the "Reference center for paraneoplastic neurological syndromes and autoimmune encephalitis" to determine the frequency of the PNS involvement in these patients.
- Conditions
- Neurological Diseases or Conditions, Neurological Diseases Associated to Anti GFAP Antibodies
- Being tested
- Clinical examination, electroneuromyography (ENMG)
- Keywords
- GFAP, neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical examinationOther
The examination performed by the clinician of the patient will be analyzed from the cohort as previously explained.
electroneuromyography (ENMG)Other
Data from the ENMGs will be extracted from the cohort and analyzed.
| Study group | Role | What they receive |
|---|---|---|
| Patients presenting with neurological symptoms and anti-GFAP antibodies in the CSF. | This is a non-interventional study involving biological samples. Samples are already stored in biobank repositories and collected as part of "good clinical practice" in the diagnostic process of patients with suspected autoimmune encephalitis, meaning that the standard diagnostic and therapeutic approaches will not be altered in the selected study population. Patients have already gave explicit written consent for biological specimens sampling and storage at the "iological Resource Center of the Hospices Civils de Lyon" (CRB-HCL) (including tissue, cells or biological fluids).
The group will be composed of patients included in the French cohort of patients with neurological syndromes and anti-GFAP antibodies in the CSF. Receives: Other: Clinical examination; Other: electroneuromyography (ENMG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cranial nerves abnormality at clinical examination of abnormal ENMG
Data concerning the clinical examination and the ENMG will be extracted from the cohort of patients with neurological syndroms and anti-GFAP antibodies identified in the cerebrospinal fluid (CSF) of the "Centre de reference des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes".
Measured: Immediately after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start1 Sep 2022
- Primary completion1 Oct 2022
- Study completion1 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurological Diseases or ConditionsStudies 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
- 120 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
- NCT05742087
- Sponsor's protocol ID
- 22-5018
- Acronym
- Neuro-GFAP
- Status last verified
- Feb 2023
- First submitted
- 1 Dec 2022
- Last updated
- 23 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Consequences of Anti-GFAP Antibodies on the Peripheral Nervous System
- ClinicalTrials.gov ID
- NCT05742087
- Acronym / sponsor ID
- Neuro-GFAP / 22-5018
- Conditions
- Neurological Diseases or Conditions, Neurological Diseases Associated to Anti GFAP Antibodies
- Keywords
- GFAP, neuropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Oct 2022 (actual)
- Study completion
- 1 May 2023 (estimated)
- First posted
- 23 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.
Anti-Glial Fibrillary Acidic Protein (GFAP) are antibodies associated to inflammatory diseases of the central nervous system. The GFAP protein is highly expressed by astrocytes explaining these syndromes, but GFAP is also expressed by immature and non-myelinating Schwann cells. Thus, these antibodies could also lead to damages of the peripheral nervous system (PNS). Moreover, such damages have already been reported on small studies, and there is a need for larger cohorts.
The investigators will use the cohort of patients with neurological syndromes and anti-GFAP antibodies identified in the cerebrospinal fluid (CSF) of the "Reference center for paraneoplastic neurological syndromes and autoimmune encephalitis" to determine the frequency of the PNS involvement in these patients.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients presenting with neurological symptoms and anti-GFAP antibodies in the CSF. | – | Other: Clinical examination, Other: electroneuromyography (ENMG)This is a non-interventional study involving biological samples. Samples are already stored in biobank repositories and collected as part of "good clinical practice" in the diagnostic process of patients with suspected autoimmune encephalitis, meaning that the standard diagnostic and therapeutic approaches will not be altered in the selected study population. Patients have already gave explicit written consent for biological specimens sampling and storage at the "iological Resource Center of the Hospices Civils de Lyon" (CRB-HCL) (including tissue, cells or biological fluids). The group will be composed of patients included in the French cohort of patients with neurological syndromes and anti-GFAP antibodies in the CSF. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 120 patients presenting with neurological symptoms and with identified anti-GFAP antibodies in the CSF, included in the French cohort of patients with neurological syndroms and anti-GFAP antibodies identified in the cerebrospinal fluid (CSF) of the "Centre de reference des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes", will be studied.
Key inclusion criteria (3 listed)
- - Age > 18 years old
- Neurological symptoms
- Anti-GFAP antibodies identified in the CSF
Key exclusion criteria (1 listed)
- - Uncomplete data in the medical records of 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 |
|---|---|---|
| Clinical examinationThe examination performed by the clinician of the patient will be analyzed from the cohort as previously explained. | Other | Patients presenting with neurological symptoms and anti-GFAP antibodies in the CSF. |
| electroneuromyography (ENMG)Data from the ENMGs will be extracted from the cohort and analyzed. | Other | Patients presenting with neurological symptoms and anti-GFAP antibodies in the CSF. |
Primary outcome
Cranial nerves abnormality at clinical examination of abnormal ENMG
Time frame: Immediately after diagnosis
Data concerning the clinical examination and the ENMG will be extracted from the cohort of patients with neurological syndroms and anti-GFAP antibodies identified in the cerebrospinal fluid (CSF) of the "Centre de reference des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
Related trials for Neurological Diseases or Conditions
Active, not recruitingPhase 1
E-CEL UVEC Cells as an Adjunct Cell Therapy for the Arthroscopic Rotator Cuff Repair in Adults
Rotator Cuff Tears, Muscle Atrophy or Weakness
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Use a Breathing Machine (PAP) (VESPER-OSA 1)
Apnea, Sleep Disorders
Not yet recruiting
Artificial Grammar Learning in Children Who Are Deaf or Hard-of-Hearing: Stimulus Length Effect
Hearing Impaired Children
Not yet recruitingPhase 1
Buprenorphine for the Management of Pain in Children With Sickle Cell Disease
Sickle Cell Disease (SCD), Sickle Cell Disease Vaso-occlusive Crisis
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 Neurological Diseases or Conditions and Neurological Diseases Associated to Anti GFAP Antibodies, 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 3 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: status not confirmed, as of the sponsor's last update on 23 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?
Results are not available in the source record.
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?
Cranial nerves abnormality at clinical examination of abnormal ENMG (time frame: Immediately after diagnosis). 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 23 Feb 2023.