Paraneoplastic Neurological SyndromeIPNSAENCT03957616
Incidence of Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis
An observational study of Paraneoplastic Neurological Syndrome and Autoimmune Encephalitis, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Paraneoplastic Neurological Syndrome, Autoimmune Encephalitis
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 30 May 2019to 31 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Data on location of diagnosis missing
- Patients diagnosed out of the mainland French territory
- Patients for whom insufficient data was available
Trial locations and contacts
1 site in 1 country.
France1 site
Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes
Lyon, 69003
About this study
Official title: 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.
- Medical subject headings
- Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and prevalence of diagnosed Paraneoplastic Neurological Syndromes (PNS) and Autoimmune Encephalitis (AE) between 2016 and 2018.
Comparison between general population of the French counties and the cohort of PNS to calculate incidence and prevalence.
Measured: 3 years
Secondary outcomes (2)
Location (city) of diagnosis
Name of city where the diagnosis of Paraneoplastic Neurological Syndromes (PNS) or Autoimmune Encephalitis (AE) was made.
Measured: 1 hour
French general population of each counties
Person years for each region
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2019
- Study start30 May 2019 (estimated)
- Primary completion30 May 2019 (estimated)
- Study completion31 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paraneoplastic Neurological SyndromeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérôme Honnorat, Principal investigator, center for paraneoplastic neurological syndromes and autoimmune encephalitis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03957616
- Sponsor's protocol ID
- IPNSAE
- Acronym
- IPNSAE
- Status last verified
- May 2019
- First submitted
- 17 May 2019
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Paraneoplastic Neurological Syndromes and Autoimmune Encephalitis in France Between 2016 and 2018
- ClinicalTrials.gov ID
- NCT03957616
- Acronym / sponsor ID
- IPNSAE / IPNSAE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 30 May 2019 (estimated)
- Primary completion
- 30 May 2019 (estimated)
- Study completion
- 31 Jul 2019 (estimated)
- First posted
- 21 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (3 listed)
- Data on location of diagnosis missing
- Patients diagnosed out of the mainland French territory
- Patients for whom insufficient data was available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Location (city) of diagnosis
Time frame: 1 hour
French general population of each counties
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jérôme Honnorat principal investigator
center for paraneoplastic neurological syndromes and autoimmune encephalitis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paraneoplastic Neurological Syndrome and Autoimmune Encephalitis, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Géraldine Picard (4 72 35 58 42 ext. 33, geraldine.picard@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and prevalence of diagnosed Paraneoplastic Neurological Syndromes (PNS) and Autoimmune Encephalitis (AE) between 2016 and 2018. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2019.