NCT05741619

Brief Summary

First described in 2010, GABA-B-receptor antibodies-associated encephalitis is a disease with a severe vital and functional prognosis. Indeed, functional status is mostly altered by encephalitis and it induced consequences while vital status is mostly engaged by cancer very often associated in the course of the disease, mostly small-cell lung cancer (SCLC). While knowledge is growing on clinical features at each stage of the disease, long-term outcome data is still lacking even if known to be pejorative. In this study, we aimed to describe long-term follow up of all patients who were diagnosed a GABAb-receptor antibodies-associated encephalitis in the French Paraneoplastic Neurological Syndrome Reference Center until now.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 23, 2023

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

5 months

First QC Date

February 14, 2023

Last Update Submit

February 14, 2023

Conditions

Keywords

anti-GABAbrautoimmune encephalitisoutcome

Outcome Measures

Primary Outcomes (1)

  • Modified-Rankin scale (mRS)

    Modified-Rankin scale (mRS) ranked from 0 (full autonomy) to 6 (death)

    At 60 month (after the beginning of the disease)

Study Arms (1)

Anti-GABABr encephalitis

This is a non-interventional study involving clinical data. This data are information of medical follow up on patient like diagnosis, symptoms, biological results, cancer, treatments.

Other: Long-term outcome

Interventions

Autonomy, physical examination, behavioural disorders

Anti-GABABr encephalitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients of reference center on paraneoplastic neurological syndrom

You may qualify if:

  • encephalitis tested positive to GABAbr-antibodies after the examination of CSF samples tested for autoimmune encephalitis at the French Paraneoplastic Neurological Syndrome Reference Center from January 2011 to January 2022.

You may not qualify if:

  • tested positive to another onconeural antibody.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes

Lyon, 69677, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

Sera and CSF at the diagnosis have been stocked in biobank (samples are already stored in biobank repositories and collected as part of "good clinical practice")

MeSH Terms

Conditions

Autoimmune Diseases of the Nervous System

Condition Hierarchy (Ancestors)

Nervous System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

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

Study Record Dates

First Submitted

February 14, 2023

First Posted

February 23, 2023

Study Start

January 1, 2022

Primary Completion

June 1, 2022

Study Completion

September 1, 2022

Last Updated

February 23, 2023

Record last verified: 2023-02

Locations