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出境医 / 临床实验 / Incidence of Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis (IPNSAE)
Incidence of Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis (IPNSAE)
Study Description
Brief Summary:
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.
| Condition or disease |
|---|
| Paraneoplastic Neurological Syndrome Autoimmune Encephalitis |
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 600 participants |
| Observational Model: | Cohort |
| Time Perspective: | Retrospective |
| Official Title: | Incidence of Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis in France Between 2016 and 2018 |
| Estimated Study Start Date : | May 30, 2019 |
| Estimated Primary Completion Date : | May 30, 2019 |
| Estimated Study Completion Date : | July 31, 2019 |
Arms and Interventions
| Group/Cohort |
|---|
|
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.
|
Outcome Measures
Primary Outcome Measures :
- Incidence and prevalence of diagnosed Paraneoplastic Neurological Syndromes (PNS) and Autoimmune Encephalitis (AE) between 2016 and 2018. [ Time Frame: 3 years ]Comparison between general population of the French counties and the cohort of PNS to calculate incidence and prevalence.
Secondary Outcome Measures :
- 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.
- French general population of each counties [ Time Frame: 3 years ]Person years for each region
Eligibility Criteria
| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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.
Criteria
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
Contacts and Locations
Contacts
| Contact: Géraldine Picard | 4 72 35 58 42 ext 33 | geraldine.picard@chu-lyon.fr | |
| Contact: Jérôme Honnorat | 4 72 35 78 06 ext 33 | jerome.honnorat@chu-lyon.fr |
Locations
| France | |
| Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes | |
| Lyon, France, 69003 | |
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
| Principal Investigator: | Jérôme Honnorat | center for paraneoplastic neurological syndromes and autoimmune encephalitis |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 17, 2019 | ||||
| First Posted Date | May 21, 2019 | ||||
| Last Update Posted Date | May 21, 2019 | ||||
| Estimated Study Start Date | May 30, 2019 | ||||
| Estimated Primary Completion Date | May 30, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Incidence and prevalence of diagnosed Paraneoplastic Neurological Syndromes (PNS) and Autoimmune Encephalitis (AE) between 2016 and 2018. [ Time Frame: 3 years ] Comparison between general population of the French counties and the cohort of PNS to calculate incidence and prevalence.
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
|
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| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Incidence of Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis | ||||
| Official Title | Incidence of Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis in France Between 2016 and 2018 | ||||
| Brief Summary | 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. | ||||
| Condition |
|
||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts | 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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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Unknown status | ||||
| Estimated Enrollment |
600 | ||||
| Original Estimated Enrollment | Same as current | ||||
| Estimated Study Completion Date | July 31, 2019 | ||||
| Estimated Primary Completion Date | May 30, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
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:
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| Sex/Gender |
|
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| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03957616 | ||||
| Other Study ID Numbers | IPNSAE | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Hospices Civils de Lyon | ||||
| Study Sponsor | Hospices Civils de Lyon | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Hospices Civils de Lyon | ||||
| Verification Date | May 2019 | ||||
