Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis Collection (SNP)

February 27, 2024 updated by: Hospices Civils de Lyon
Numerous neurological disorders affecting the central and peripheral nervous system can be attributed to the immune system through multiple effector mechanisms. However, current treatments could be drastically improved by faster and more accurate diagnosis. The sample collection will benefit to patients with rare neuroimmune syndromes such as Autoimmune Encephalitis (AE) and Paraneoplastic Neurological Syndromes (PNS) leading to a better and early diagnosis, as well as treatment improvement.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Aix-en-Provence, France, 13616
        • Not yet recruiting
        • Neurology
        • Contact:
        • Principal Investigator:
          • Laurent MARTINEZ ALMOYNA, MD
      • Amiens, France, 80000
      • Angers, France, 49055
      • Annecy, France, 74370
      • Avignon, France, 84000
      • Bayonne, France, 64100
        • Not yet recruiting
        • Neurologie
        • Contact:
        • Principal Investigator:
          • Olivier FLABEAU, MD
      • Besançon, France, 25056
        • Recruiting
        • Neurology
        • Contact:
        • Principal Investigator:
          • Nathalie Devys Meyer, MD
      • Bobigny, France, 93000
        • Not yet recruiting
        • Neurology
        • Contact:
          • Marie MONGIN, MD
        • Principal Investigator:
          • Marie MONGIN, MD
      • Bordeaux, France, 33000
        • Not yet recruiting
        • Neurology
        • Contact:
        • Principal Investigator:
          • Frederic VILLEGA, MD
      • Brest, France, 29200
        • Not yet recruiting
        • Neurology
        • Principal Investigator:
          • Serge TIMSIT, MD
        • Contact:
      • Cannes, France, 06400
        • Not yet recruiting
        • Intensive Care Medicine
        • Contact:
        • Principal Investigator:
          • CHAMBON Raphaël, MD
      • Chambéry, France, 73011
      • Clermont-Ferrand, France, 63003
        • Not yet recruiting
        • Neurology
        • Contact:
        • Principal Investigator:
          • Eve CHANSON, MD
      • Colmar, France, 68000
        • Not yet recruiting
        • Neurologie
        • Principal Investigator:
          • François SELLAL, MD
        • Contact:
      • Créteil, France, 94010
        • Not yet recruiting
        • Neurology
        • Contact:
        • Principal Investigator:
          • Thierry GENDRE, MD
      • Dijon, France, 21231
        • Not yet recruiting
        • General, Vascular and Degenerative Neurology
        • Contact:
        • Principal Investigator:
          • Yannick BEJOT, MD
      • Gap, France, 05000
        • Not yet recruiting
        • Internal and general practitioner
        • Contact:
          • Thierry WEITTEN, MD
          • Phone Number: 33 0492407680
        • Principal Investigator:
          • WEITTEN Thierry, MD
      • Grenoble, France
        • Recruiting
        • Neurologie
        • Principal Investigator:
          • Martial MALLARET, MD
        • Contact:
      • La Roche-sur-Yon, France, 85925
        • Not yet recruiting
        • Neurology
        • Contact:
        • Principal Investigator:
          • Nathalie Testard, MD
      • Lille, France, 59000
        • Not yet recruiting
        • Neurology
        • Contact:
        • Principal Investigator:
          • Jean Paul Niguet, MD
      • Lille, France
      • Limoges, France, 87042
        • Not yet recruiting
        • Neurology
        • Contact:
        • Principal Investigator:
          • Laurent MAGY, MD
      • Lisieux, France, 14100
        • Not yet recruiting
        • Neurology
        • Contact:
        • Principal Investigator:
          • Doina Ciocanu, MD
      • Lyon, France, 69677
        • Recruiting
        • Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes
        • Contact:
        • Principal Investigator:
          • Jerome HONNORAT, Pr
      • Marseille, France, 13005
        • Not yet recruiting
        • Adult Neurology and Neuropsychology
        • Contact:
        • Principal Investigator:
          • Elsa KAPHAN, MD
      • Marseille, France, 13385
        • Not yet recruiting
        • Neurologie
        • Contact:
        • Principal Investigator:
          • MAAROUF Adil, MD
      • Marseille, France
        • Not yet recruiting
        • Neurology
        • Contact:
          • Hanna BOU ALI, MD
        • Principal Investigator:
          • Hanna BOU ALI, MD
      • Metz, France, 57085
      • Montivilliers, France, 76290
        • Not yet recruiting
        • Neurology
        • Contact:
        • Principal Investigator:
          • Alexandre LECLANCHER, MD
      • Montpellier, France, 34295
        • Not yet recruiting
        • General Neurology
        • Contact:
        • Principal Investigator:
          • Mahmoud CHARIF, MD
      • Mulhouse, France, 68070
        • Not yet recruiting
        • General medicine
        • Contact:
        • Principal Investigator:
          • Sohrab MOSTOUFIZADEH, MD
      • Mâcon, France, 71000
        • Not yet recruiting
        • Neurology
        • Contact:
        • Principal Investigator:
          • Patricia DEPIERRE, MD
      • Nancy, France, 54035
        • Not yet recruiting
        • Neurologie
        • Contact:
        • Principal Investigator:
          • Louise TYVAERT, MD
      • Nantes, France, 44093
        • Not yet recruiting
        • Neurology
        • Contact:
        • Principal Investigator:
          • Hélène COURTEMANCHE, MD
      • Nice, France, 06000
        • Not yet recruiting
        • Neurologie
        • Contact:
        • Principal Investigator:
          • BOURG Véronique, MD
      • Nîmes, France, 30029
        • Not yet recruiting
        • Neurology
        • Contact:
          • Giovanni CASTELNOVO
          • Phone Number: 33 466683261
        • Principal Investigator:
          • CASTELNOVO Giovanni, MD
      • Paris, France, 75014
        • Not yet recruiting
        • Neurology
        • Contact:
        • Principal Investigator:
          • Clément VIALATTE DE PEMILLE, MD
      • Paris, France, 75015
        • Not yet recruiting
        • Neuropediatrics
        • Contact:
        • Principal Investigator:
          • Melodie AUBART, MD
      • Paris, France, 75018
        • Not yet recruiting
        • Intensive Care Medicine
        • Contact:
        • Principal Investigator:
          • Romain SONNEVILLE, MD
      • Paris, France, 75019
        • Not yet recruiting
        • Neurology
        • Contact:
        • Principal Investigator:
          • Marine Boudot de La Motte, MD
      • Paris, France, 75651
        • Not yet recruiting
        • Onco-neurology
        • Contact:
        • Principal Investigator:
          • Dimitri PSIMARAS, MD
      • Paris, France, 94275
        • Not yet recruiting
        • Neurology adult
        • Contact:
        • Principal Investigator:
          • Céline LABEYRIE, MD
      • Poitiers, France
        • Not yet recruiting
        • Neurology, neuropsychology and language rehabilitation
        • Contact:
        • Principal Investigator:
          • NEAU Jean-Philippe, MD
      • Reims, France, 51100
        • Not yet recruiting
        • Neurology
        • Contact:
        • Principal Investigator:
          • Maximilien MOULIN, MD
      • Rennes, France, 35000
        • Not yet recruiting
        • Neurology
        • Principal Investigator:
          • Anca NICA, MD
        • Contact:
      • Rouen, France, 76038
        • Not yet recruiting
        • Vascular and general neurology
        • Contact:
          • Benjamin HEBANT, MD
        • Principal Investigator:
          • Benjamin HEBANT, MD
      • Saint-Brieuc, France, 22000
        • Not yet recruiting
        • Neurology
        • Contact:
          • Olivier VERCRUYSSE, MD
        • Principal Investigator:
          • Olivier VERCRUYSSE, MD
      • Saint-Denis, France, 93200
        • Not yet recruiting
        • Neurology
        • Contact:
        • Principal Investigator:
          • Mickael BONNAN, MD
      • Saint-Malo, France, 35400
        • Not yet recruiting
        • Neurology
        • Contact:
        • Principal Investigator:
          • Alexandre Bonnet, MD
      • Saint-Nazaire, France, 44600
        • Not yet recruiting
        • Neurologie
        • Contact:
        • Principal Investigator:
          • Lucie Metzger, MD
      • Saint-Étienne, France, 42055
      • Strasbourg, France, 67098
        • Not yet recruiting
        • Neurologie
        • Contact:
        • Principal Investigator:
          • Christine TRANCHANT, MD
      • Strasbourg, France, 67098
        • Not yet recruiting
        • Neurology
        • Contact:
        • Principal Investigator:
          • Edouard HIRSCH, MD
      • Suresnes, France, 92150
        • Not yet recruiting
        • Neurology
        • Contact:
        • Principal Investigator:
          • Adrien WANG, MD
      • Toulon, France, 83100
        • Not yet recruiting
        • Neurology
        • Contact:
        • Principal Investigator:
          • Elena-Camelia RUSU, MD
      • Toulon, France, 83800
        • Not yet recruiting
        • Neurology
        • Contact:
        • Principal Investigator:
          • Anthony FAIVRE, MD
      • Tours, France, 37000
        • Not yet recruiting
        • Neurologie
        • Contact:
        • Principal Investigator:
          • Coline DUWICQUET, MD
      • Valenciennes, France, 59300
        • Not yet recruiting
        • Neurology
        • Contact:
        • Principal Investigator:
          • Marianne GIROUX, MD
      • Vannes, France, 56000
      • Versailles, France
        • Not yet recruiting
        • Neurology
        • Contact:
        • Principal Investigator:
          • Jérôme SERVAN, MD
      • Épinal, France, 88023
        • Recruiting
        • Neurology
        • Contact:
        • Principal Investigator:
          • Arnaud LARDIN, MD
    • Guadeloupe
      • POINTE-à-pitre, Guadeloupe, France, 97159
        • Not yet recruiting
        • Neurology
        • Contact:
        • Principal Investigator:
          • Hugo CHAUMONT, MD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient with consent
  • Patient with well-characterized antibodies in serum or cerebrospinal fluid or not
  • Patient with neurological disorder compatible with PNS or auto-immune encephalitis

Exclusion Criteria:

  • Refusal of consent
  • 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: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Paraneoplastic neurological syndrome patients and autoimmune encephalitis patient
patients with diagnosis of paraneoplastic neurological syndrome or autoimmune encephalitis
Biological: Collection of biological sample with sera, CSF, buffy coat, PBMC, plasma.

Blood is collected only one time by blood sample to obtain serum, buffy coat, plasma and PBMC.

2 *4ml of blood on dry tube 2 *4ml of blood on EDTA tube If possibility of delivery in 48 hours at the Centre of Biological Resources, 7*4ml of blood on heparin tube If cerebrospinal fluid has been drawn for diagnosis, remaining sample available will be stored in the collection

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Blood Samples
Time Frame: 10 years
Assessment of biocollection of blood samples
10 years
Cerebrospinal fluid biocollection
Time Frame: 10 years
Assessment of biocollection of Cerebrospinal fluid
10 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Scientific collaboration
Time Frame: 10 years
Number of project issued from the biocollection
10 years
Scientific
Time Frame: 10 years
Number of scientific papers issued from the biocollection
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospices Civils de Lyon

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 2, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 2, 2032

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 2, 2032

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 69HCL21_1271

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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