Characterisation of Clinical Phenotypes and Outcomes of Ma2 Patient

Completed

• Conditions: Autoimmune Encephalitis; Paraneoplastic Syndromes
• Interventions: Diagnostic Test: Diagnosis test

• Registration Number: NCT05645185
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Paraneoplastic neurological syndromes (PNS) are rare complications of cancer occurring in 0.01% of cases. Their clinical, biological and radiological presentation is heterogeneous and may constitute a diagnostic challenge. Anti-Ma2 PNS are rare diseases with a guarded prognosis. They are most often associated with a seminoma-like testicular tumor but can also be associated with lung cancer. Classically, they present as limbic, diencephalic and/or brainstem encephalitis. Anti-Ma2 antibodies target intracellular receptors and are characteristic of a particular form of encephalitis. Atypical manifestations including narcolepsy-cataplexy, weight gain, sexual dysfunction and motor neuron syndrome have been described and explain the difficulty in diagnosing anti-Ma2 associated PNS. It seems interesting to better characterize the phenotypes of Ma2 patients in order to optimize the diagnosis and follow-up.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-10-01
• Primary Completion: 2022-03-01
• Study Completion: 2022-10-01
• Status Verified: 2022-12
• Study First Submitted: 2022-12-01
• Study First Submitted QC: 2022-12-08
• Last Update Submitted: 2022-12-08
• Study First Posted: 2022-12-09
• Last Update Posted: 2022-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

Inclusion Criteria

• Neurological disorder
• Anti-Ma2 positivity in sera or CSF
• Patient > 18 years old

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Exclusion Criteria

• Patient without clinical data
• Patient without Ma2 antibody in sera or CSF

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient with Ma2 antibody	Diagnosis test	This is a non-interventional study involving biological samples. Samples are already stored in biobank repositories and collected as part of "good clinical practice" in the diagnostic process of patients with suspected autoimmune encephalitis, meaning that the standard diagnostic and therapeutic approaches will not be altered in the selected study population. Patients have already gave explicit written consent for biological specimens sampling and storage at the "Centre de Ressources Biologiques des Hospices Civils de Lyon" (CRB-HCL) (including tissue, cells or biological fluids).

Primary Outcome Measures

Name	Time	Method
Rankin score	12 month after diagnosis	Follow up and survival (rankin score)

Trial Locations

Locations (1)

Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes; 🇫🇷 Lyon, France