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Risk Prediction Model for Severe Autoimmune Encephalitis

NCT ID: NCT06697678

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2028-12-31

Brief Summary

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A prospective study aims to establish a multicenter clinical diagnosis and treatment database for patients with autoimmune encephalitis (AE). The study will analyze the characteristics of disease progression, changes in immune-inflammatory markers, immunotherapy regimens, and patient outcomes. It seeks to identify clinical indicators for the early recognition of severe AE patients, develop and validate a predictive model for severe AE, and explore effective treatment strategies to rapidly control disease progression during the acute phase of severe AE.

Detailed Description

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To develop and validate a predictive model for severe autoimmune encephalitis (AE), a prospective multicenter study will be conducted. Clinical data of hospitalized AE patients will be collected consecutively, and a multicenter integrated database will be established. This database will include information on the characteristics of disease progression, changes in blood and cerebrospinal fluid immune-inflammatory markers, specific immunotherapy regimens, patient outcomes, and long-term prognoses. The study will analyze the clinical and immunological characteristics of AE patients, identify clinical indicators for early recognition of severe AE, and develop and validate a predictive model for severe AE. Additionally, the study will evaluate the efficacy of early plasma exchange/plasma adsorption therapy and targeted immunotherapy on AE outcomes and long-term prognosis, aiming to explore effective treatment strategies for rapidly controlling disease progression in the acute phase of severe AE.

Conditions

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Severe Autoimmune Encephalitis

Keywords

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severe autoimmune encephalitis prediction model plasma exchange therapy plasma adsorption therapy targeted immunotherapy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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patients with severe autoimmune encephalitis

No intervention

No Intervention: Observational Cohort

Intervention Type OTHER

No intervention

patients with non-severe autoimmune encephalitis

No Intervention: Observational Cohort

Intervention Type OTHER

No intervention

Interventions

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No Intervention: Observational Cohort

No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* age 14-80 years
* no restriction on gender
* meets the diagnostic criteria for confirmed AE, with a clearly identified pathogenic antibody
* within 3 months of AE
* patients voluntarily sign the informed consent form; if unable to express their will or sign, the consent form can be signed by a close relative on their behalf

Exclusion Criteria

* no lumbar puncture performed for CSF antibody testing
* did not receive immunotherapy
* pre-onset modified Rankin Scale (mRS) score ≥3
Minimum Eligible Age

14 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xuanwu Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Yan Zhang

Role: CONTACT

Phone: 0086-13671376710

Email: [email protected]

Other Identifiers

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AE

Identifier Type: -

Identifier Source: org_study_id