- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03957616
Incidence of Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis (IPNSAE)
May 17, 2019 updated by: Hospices Civils de Lyon
Incidence of Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis in France Between 2016 and 2018
This study aims to provide an estimate of the incidence of paraneoplastic neurological syndromes and autoimmune encephalitides in France between the years 2016 and 2018.
The study will describe the incidence of antibody subtypes and regional variations.
Study Overview
Status
Unknown
Study Type
Observational
Enrollment (Anticipated)
600
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Lyon, France, 69003
- Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients diagnosed with a paraneoplastic neurological syndrome or autoimmune encephalitis in France and referred to the national center in Lyon between 2016 and 2018.
Description
Inclusion Criteria:
- Clinical diagnosis of Paraneoplastic Neurological Syndrome (PNS) or Autoimmune Encephalitis (AE) made by the referring physician to the national center for PNS and AE in Lyon between 2016 and 2018
Exclusion Criteria:
- Data on location of diagnosis missing
- Patients diagnosed out of the mainland French territory
- Patients for whom insufficient data was available
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
|---|
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Paraneoplastic neurological syndromes patients
Patients tested for Paraneoplastic neurological syndromes (PNS) and Autoimmune Encephalitis (AE) with a lumbar puncture, with detection of an antibody or negative, but with PNS clinically diagnosed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Incidence and prevalence of diagnosed Paraneoplastic Neurological Syndromes (PNS) and Autoimmune Encephalitis (AE) between 2016 and 2018.
Time Frame: 3 years
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Comparison between general population of the French counties and the cohort of PNS to calculate incidence and prevalence.
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3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Location (city) of diagnosis
Time Frame: 1 hour
|
Name of city where the diagnosis of Paraneoplastic Neurological Syndromes (PNS) or Autoimmune Encephalitis (AE) was made.
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1 hour
|
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French general population of each counties
Time Frame: 3 years
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Person years for each region
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3 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jérôme Honnorat, center for paraneoplastic neurological syndromes and autoimmune encephalitis
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 30, 2019
Primary Completion (Anticipated)
May 30, 2019
Study Completion (Anticipated)
July 31, 2019
Study Registration Dates
First Submitted
May 17, 2019
First Submitted That Met QC Criteria
May 17, 2019
First Posted (Actual)
May 21, 2019
Study Record Updates
Last Update Posted (Actual)
May 21, 2019
Last Update Submitted That Met QC Criteria
May 17, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IPNSAE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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