SNP: Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis Collection

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05198661

Collaborator

(none)

3,500

Enrollment

Location

Arm

120

Anticipated Duration (Months)

29.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Paraneoplastic Neurological Syndromes or Autoimmune Encephalitis	Biological: Collection of biological sample with sera, CSF, buffy coat, PBMC, plasma.	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

3500 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Blood sampleBlood sample

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis Collection

Anticipated Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Feb 1, 2032

Anticipated Study Completion Date :

Feb 1, 2032

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Blood Samples [10 years]
Assessment of biocollection of blood samples
Cerebrospinal fluid biocollection [10 years]
Assessment of biocollection of Cerebrospinal fluid

Secondary Outcome Measures

Scientific collaboration [10 years]
Number of project issued from the biocollection
Scientific [10 years]
Number of scientific papers issued from the biocollection

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes	Lyon		France	69677

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT05198661

Other Study ID Numbers:

69HCL21_1271

First Posted:

Jan 20, 2022

Last Update Posted:

Jan 20, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospices Civils de Lyon

Paraneoplastic Neurological Syndromes

Autoimmune Encephalitis

biological collection

Additional relevant MeSH terms:

Encephalitis

Hashimoto Disease

Syndrome

Study Results

No Results Posted as of Jan 20, 2022