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Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis Collection (SNP)

Primary Purpose

Paraneoplastic Neurological Syndromes or Autoimmune Encephalitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Collection of biological sample with sera, CSF, buffy coat, PBMC, plasma.
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Paraneoplastic Neurological Syndromes or Autoimmune Encephalitis focused on measuring Paraneoplastic Neurological Syndromes, Autoimmune Encephalitis, biological collection

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Paraneoplastic neurological syndrome patients and autoimmune encephalitis patient

Arm Description

patients with diagnosis of paraneoplastic neurological syndrome or autoimmune encephalitis

Outcomes

Primary Outcome Measures

Blood Samples
Assessment of biocollection of blood samples
Cerebrospinal fluid biocollection
Assessment of biocollection of Cerebrospinal fluid

Secondary Outcome Measures

Scientific collaboration
Number of project issued from the biocollection
Scientific
Number of scientific papers issued from the biocollection

Full Information

First Posted
December 20, 2021
Last Updated
January 6, 2022
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT05198661
Brief Title
Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis Collection
Acronym
SNP
Official Title
Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis Collection
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2022 (Anticipated)
Primary Completion Date
February 2032 (Anticipated)
Study Completion Date
February 2032 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Paraneoplastic Neurological Syndromes or Autoimmune Encephalitis
Keywords
Paraneoplastic Neurological Syndromes, Autoimmune Encephalitis, biological collection

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Blood sample
Masking
None (Open Label)
Allocation
N/A
Enrollment
3500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Paraneoplastic neurological syndrome patients and autoimmune encephalitis patient
Arm Type
Other
Arm Description
patients with diagnosis of paraneoplastic neurological syndrome or autoimmune encephalitis
Intervention Type
Biological
Intervention Name(s)
Collection of biological sample with sera, CSF, buffy coat, PBMC, plasma.
Intervention Description
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
Primary Outcome Measure Information:
Title
Blood Samples
Description
Assessment of biocollection of blood samples
Time Frame
10 years
Title
Cerebrospinal fluid biocollection
Description
Assessment of biocollection of Cerebrospinal fluid
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Scientific collaboration
Description
Number of project issued from the biocollection
Time Frame
10 years
Title
Scientific
Description
Number of scientific papers issued from the biocollection
Time Frame
10 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jerome HONNORAT, Pr
Phone
4 72 35 78 06
Ext
+33
Email
jerome.honnorat@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Geraldine PICARD
Phone
4 72 35 58 42
Ext
+33
Email
geraldine.picard@chu-lyon.fr
Facility Information:
Facility Name
Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes
City
Lyon
ZIP/Postal Code
69677
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis Collection

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