- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05370079
Control Cohort CTRL COH (CTRL COH)
January 13, 2026 updated by: Hospices Civils de Lyon
Autoimmune encephalitis (AE) and paraneoplastic neurological syndromes (PNS) are rare disease that could be difficult to diagnose.
So it necessary to obtain numerous sample from different disease to develop more specific diagnosis kit It could be possible through the characterisation of new genetic biomarkers.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
350
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jerome HONNORAT, Pr
- Phone Number: (33) 4 72 35 78 06
- Email: jerome.honnorat@chu-lyon.fr
Study Contact Backup
- Name: Géraldine Picard, CRA
- Phone Number: (33) 4 72 35 58 42
- Email: geraldine.picard@chu-lyon.fr
Study Locations
-
-
-
Bron, France, 69500
- Recruiting
- Hospices Civils de Lyon
-
Contact:
- Jerome HONNORAT, Pr
- Phone Number: (33) 4 72 35 78 06
- Email: jerome.honnorat@chu-lyon.fr
-
Principal Investigator:
- Jerome HONNORAT
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- patient with consent
- patient with following disease: Parkinson's disease, Amyotrophic lateral sclerosis, Glioblastoma, cancer without neurological disease (pulmonary cancer, breast cancer, ovarian cancer, melanoma, thymoma), rheumatoid arthritis.
Exclusion Criteria:
- refusal consent
- patient with neurological disorder compatible with paraneoplastic neurological syndrome or auto-immune encephalitis
- patient under guardianship
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control cohort
Patient with following disease: Parkinson's disease, Amyotrophic lateral sclerosis, Glioblastoma, cancer without neurological disease (pulmonary cancer, breast cancer, ovarian cancer, melanoma, thymoma), rheumatoid arthritis.
|
Blood sample will be collected one time for each patient: 2 *4ml of blood on dry tube 2 *4ml of blood on EDTA tube If cerebrospinal fluid (CSF) has been drawn for diagnosis, remaining sample available will be stored in the control cohort (1 ml). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Samples (blood dry and EDTA tube and optional cerebro-spinal-fluid)
Time Frame: 15 minutes
|
Numbers of samples collected and patients included in the cohort
|
15 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Description of genetic analysis
Time Frame: Data collecting: 3 years Data analysis: 2 years
|
Number of new biomarkers (genetic) and specific HLA (human leucocyte antigen)
|
Data collecting: 3 years Data analysis: 2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jerome Honnorat, Pr, Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes, Lyon, France
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 8, 2023
Primary Completion (Estimated)
August 8, 2028
Study Completion (Estimated)
August 8, 2028
Study Registration Dates
First Submitted
May 6, 2022
First Submitted That Met QC Criteria
May 6, 2022
First Posted (Actual)
May 11, 2022
Study Record Updates
Last Update Posted (Actual)
January 15, 2026
Last Update Submitted That Met QC Criteria
January 13, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Synucleinopathies
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms
- Neuromuscular Diseases
- Metabolic Diseases
- Neoplasms by Histologic Type
- Neurodegenerative Diseases
- Neoplasms, Glandular and Epithelial
- Astrocytoma
- Glioma
- Neoplasms, Neuroepithelial
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Movement Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Spinal Cord Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Motor Neuron Disease
- Nutritional and Metabolic Diseases
- Glioblastoma
- Parkinson Disease
- Amyotrophic Lateral Sclerosis
Other Study ID Numbers
- 69HCL22_0275
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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