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Control Cohort CTRL COH (CTRL COH)

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ClinicalTrials.gov Identifier: NCT05370079
Recruitment Status : Not yet recruiting
First Posted : May 11, 2022
Last Update Posted : September 14, 2022
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Study Description
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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
Parkinson's Disease; Amyotrophic Lateral Sclerosis; Glioblastoma; Cancer Without Neurological Disease; Rheumatoid Polyarthritis Biological: Collection of biological sample (blood and/or CSF) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Control Cohort CTRL COH
Estimated Study Start Date : September 16, 2022
Estimated Primary Completion Date : September 16, 2027
Estimated Study Completion Date : September 16, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05370079


Contacts
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Contact: Jerome Honnorat, Pr (33) 4 72 35 78 06 jerome.honnorat@chu-lyon.fr
Contact: Mathilde Millot, CRA (33) 4 72 35 70 58 mathilde.millot@chu-lyon.fr

Locations
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France
Hospices Civils de Lyon
Bron, France, 69500
Contact: Jerome HONNORAT, Pr    (33) 4 72 35 78 06    jerome.honnorat@chu-lyon.fr   
Principal Investigator: Jerome HONNORAT         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Jerome Honnorat, Pr Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes, Lyon, France
More Information
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT05370079    
Other Study ID Numbers: 69HCL22_0275
First Posted: May 11, 2022    Key Record Dates
Last Update Posted: September 14, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Biological collection, control cohort,, new biomarkers
Additional relevant MeSH terms:
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Glioblastoma
Arthritis
Parkinson Disease
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Nervous System Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Astrocytoma
Glioma
 Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neuromuscular Diseases
Spinal Cord Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Joint Diseases
Musculoskeletal Diseases