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NCT05745792 Clinical Trial

Clinico-immunological Characterization and Immune Tolerance Breakdown in HU-autoimmunity

Immune Tolerance Clinical Trial

— CarTo-Hu  

Official title:
Clinico-immunological Characterization and Immune Tolerance Breakdown in HU-autoimmunity

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05745792
Other study ID # 751
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 1, 2022
Est. completion date February 1, 2025

Study information
Verified date February 2023
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Phenotypic characterization of patients with Hu-Abs, including the different neurological presentation and the presence or not of an underlying cancer. Analysis and clinical correlation of the diagnostic techniques for Hu-Abs detection (immunofluorescence, immunodot/Western blot, and CBA) in serum and/or CSF. Genomic and transcriptomic features of tumors (histological and immune infiltrate characteristics, transcriptomic profile, mutational status).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 400
Est. completion date February 1, 2025
Est. primary completion date October 1, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility - Inclusion Criteria * : - Patient with neurological disorder - Patient with Hu antibody in sera or CSF - Exclusion Criteria * : - Patient with no data - Patient without neurological disorder - Patient without Hu antibody in sera/CSF

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Description of clinical, immunological and tumor features of patients harboring Hu Abs
This observationnal study involves clinical data and bio. samples (DNA and tumors block). Demographic and clinical data already in French Reference Center on PNS database will be reviewed. Additional data will be obtained from the referral physicians. The results of diagnostic tests performed to detect Hu-Abs in the patients are already in this database and will be retrospectively analyzed. In addition, the 4 available techniques (immunofluorescence, commercial immunodot, Western blot, and CBA) will be performed from Jan. 2022 to Dec. 2022.Tumor samples from 2 cohorts will be analyzed: (i) tumors of patients with Hu-Abs and PNS, and (ii) tumors of patients without PNS (mostly SCLC). After selecting patients, the study will involve 3 steps: (i) pathological confirmation; (ii) DNA sequencing and CNV analysis (panel of genes involved in anti-Hu autoimmunity; mainly ELAVL1 to 4, encoding for HuA to HuD, the 4 main proteins of the Hu family); and (iii) whole-genome RNA sequencing.

Locations
Country Name City State
France Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes Lyon

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Modified Rankin Scale (mRs) Application of modified rankin scale At 1 year
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