Long-term Follow up of Patient With Anti-GABAbr Antibodie... | NCT05741619

Studies
Long-term Follow up of Patient With Anti-GABAbr Antibodies Associated-encephalitis.

NCT05741619

Sponsor

Hospices Civils de Lyon

Status

Completed

Last Update Posted

Feb 23, 2023Actual

Enrollment

70Actual

Phase

Not provided

Conditions

Autoimmune Encephalitis

Interventions

Long-term outcome

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2022Actual

Primary Completion Date

Jun 1, 2022Actual

Completion Date

Sep 1, 2022Actual

First Submitted Date

Feb 14, 2023

First Submission Date that Met QC Criteria

Feb 14, 2023

First Posted Date

Feb 23, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2023

Last Update Posted Date

Feb 23, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Long-term outcome	Other	Autonomy, physical examination, behavioural disorders	Anti-GABABr encephalitis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

tested positive to another onconeural antibody.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients of reference center on paraneoplastic neurological syndrom

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes		Lyon		69677	France

Condition Browse Module

MeSH Terms

ID	Term
D020274	Autoimmune Diseases of the Nervous System

Ancestor Terms

ID	Term
D009422	Nervous System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided