Control Cohort CTRL COH

Sponsor
Hospices Civils de Lyon (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05370079
Collaborator
(none)
350
1
1
60
5.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Collection of biological sample (blood and/or CSF)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
350 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Control Cohort CTRL COH
Anticipated Study Start Date :
Aug 1, 2022
Anticipated Primary Completion Date :
Aug 1, 2027
Anticipated Study Completion Date :
Aug 1, 2027

Arms and Interventions

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.

Biological: Collection of biological sample (blood and/or CSF)
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).

Outcome Measures

Primary Outcome Measures

  1. Samples (blood dry and EDTA tube and optional cerebro-spinal-fluid) [15 minutes]

    Numbers of samples collected and patients included in the cohort

Secondary Outcome Measures

  1. Description of genetic analysis [Data collecting: 3 years Data analysis: 2 years]

    Number of new biomarkers (genetic) and specific HLA (human leucocyte antigen)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospices Civils de Lyon Bron France 69500

Sponsors and Collaborators

  • Hospices Civils de Lyon

Investigators

  • Principal Investigator: Jerome Honnorat, Pr, Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes, Lyon, France

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT05370079
Other Study ID Numbers:
  • 69HCL22_0275
First Posted:
May 11, 2022
Last Update Posted:
May 11, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospices Civils de Lyon
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 11, 2022