NCT03957616

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 21, 2019

Completed
9 days until next milestone

Study Start

First participant enrolled

May 30, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

May 21, 2019

Status Verified

May 1, 2019

Enrollment Period

Same day

First QC Date

May 17, 2019

Last Update Submit

May 17, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 years

Secondary Outcomes (2)

  • Location (city) of diagnosis

    1 hour

  • French general population of each counties

    3 years

Study Arms (1)

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \- 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

You may not qualify if:

  • Data on location of diagnosis missing
  • Patients diagnosed out of the mainland French territory
  • Patients for whom insufficient data was available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites auto-immunes

Lyon, 69003, France

Location

MeSH Terms

Conditions

Autoimmune Diseases of the Nervous System

Condition Hierarchy (Ancestors)

Nervous System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Jérôme Honnorat

    center for paraneoplastic neurological syndromes and autoimmune encephalitis

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2019

First Posted

May 21, 2019

Study Start

May 30, 2019

Primary Completion

May 30, 2019

Study Completion

July 31, 2019

Last Updated

May 21, 2019

Record last verified: 2019-05

Locations