Back to resultsControl Cohort CTRL COH (CTRL COH)
Primary Purpose
Parkinson's Disease; Amyotrophic Lateral Sclerosis; Glioblastoma; Cancer Without Neurological Disease; Rheumatoid Polyarthritis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Collection of biological sample (blood and/or CSF)
Sponsored by
About this trial
This is an interventional diagnostic trial for Parkinson's Disease; Amyotrophic Lateral Sclerosis; Glioblastoma; Cancer Without Neurological Disease; Rheumatoid Polyarthritis focused on measuring Biological collection, control cohort,, new biomarkers
Eligibility 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
Sites / Locations
- Hospices Civils de LyonRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Control cohort
Arm Description
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.
Outcomes
Primary Outcome Measures
Samples (blood dry and EDTA tube and optional cerebro-spinal-fluid)
Numbers of samples collected and patients included in the cohort
Secondary Outcome Measures
Description of genetic analysis
Number of new biomarkers (genetic) and specific HLA (human leucocyte antigen)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05370079
Brief Title
Control Cohort CTRL COH
Acronym
CTRL COH
Official Title
Control Cohort CTRL COH
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 8, 2023 (Actual)
Primary Completion Date
August 8, 2028 (Anticipated)
Study Completion Date
August 8, 2028 (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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease; Amyotrophic Lateral Sclerosis; Glioblastoma; Cancer Without Neurological Disease; Rheumatoid Polyarthritis
Keywords
Biological collection, control cohort,, new biomarkers
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
350 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control cohort
Arm Type
Other
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Collection of biological sample (blood and/or CSF)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Samples (blood dry and EDTA tube and optional cerebro-spinal-fluid)
Description
Numbers of samples collected and patients included in the cohort
Time Frame
15 minutes
Secondary Outcome Measure Information:
Title
Description of genetic analysis
Description
Number of new biomarkers (genetic) and specific HLA (human leucocyte antigen)
Time Frame
Data collecting: 3 years Data analysis: 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jerome Honnorat, Pr
Phone
(33) 4 72 35 78 06
Email
jerome.honnorat@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Mathilde Millot, CRA
Phone
(33) 4 72 35 70 58
Email
mathilde.millot@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jerome Honnorat, Pr
Organizational Affiliation
Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes, Lyon, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jerome HONNORAT, Pr
Phone
(33) 4 72 35 78 06
Email
jerome.honnorat@chu-lyon.fr
First Name & Middle Initial & Last Name & Degree
Jerome HONNORAT
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Control Cohort CTRL COH
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