NCT07036042

Brief Summary

Autoimmune encephalitis (AE) is an important autoimmune neurological disease, and its clinical manifestations, treatment and prognosis are closely related to the type of pathogenic antibodies. However, due to the limited antibody spectrum and the unclear pathogenic mechanism, the disease is difficult to diagnose and treat, and the morbidity and mortality rates are high. In a previous study, we found that anti-CRMP2 antibodies were AE-specific autoantibodies, adding a new member to the AE antibody spectrum and thus defining a new class of AEs, anti-CRMP2 encephalitis. However, due to the limited number of cases, its clinical characteristics such as incidence, concomitant diseases, imaging manifestations, treatment effects and prognosis are not yet clear. This study plans to conduct large-scale anti-CRMP2 antibody screening in critically ill patients with suspected neurological autoimmune diseases in our hospital, and compare the clinical differences between anti-CRMP2 encephalitis and other known AEs and non-autoimmune encephalitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2022

Typical duration 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

June 1, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 25, 2025

Completed
Last Updated

June 26, 2025

Status Verified

June 1, 2025

Enrollment Period

2.6 years

First QC Date

June 17, 2025

Last Update Submit

June 25, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Antibodies CRMP2 detected in blood or cerebrospinal fluid

    2024.12

Eligibility Criteria

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

Patients admitted to the Department of Neurology, Nanfang Hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanfang hospital

Guangzhou, Guangdong, 510515, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood and cerebrospinal fluid

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
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2025

First Posted

June 25, 2025

Study Start

June 1, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

June 26, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

All participants' data are confidential.

Locations