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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05745792
Acronym
CarTo-Hu
Enrollment
400
Registered
2023-02-27
Start date
2022-02-01
Completion date
2025-02-01
Last updated
2023-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Immune Tolerance

Keywords

PARANEOPLASTIC NEUROLOGICAL DISORDERS, LUNG CANCER, HU AUTOIMMUNITY, IMMUNE TOLERANCE BREAKDOWN

Brief 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).

Interventions

OTHERDescription 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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Modified Rankin Scale (mRs)At 1 yearApplication of modified rankin scale

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026