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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT05741619

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

8.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autoimmune Encephalitis	Other: Long-term outcome

Study Design

Study Type:

Observational

Actual Enrollment :

70 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 1, 2022

Actual Primary Completion Date :

Jun 1, 2022

Actual Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
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 Autonomy, physical examination, behavioural disorders

Arm

Intervention/Treatment

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

Autonomy, physical examination, behavioural disorders

Outcome Measures

Primary Outcome Measures

Modified-Rankin scale (mRS) [At 60 month (after the beginning of the disease)]
Modified-Rankin scale (mRS) ranked from 0 (full autonomy) to 6 (death)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes	Lyon		France	69677

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT05741619

Other Study ID Numbers:

First Posted:

Feb 23, 2023

Last Update Posted:

Feb 23, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospices Civils de Lyon

anti-GABAbr

autoimmune encephalitis

outcome

Additional relevant MeSH terms:

Encephalitis

Study Results

No Results Posted as of Feb 23, 2023