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Status unknownNCT05745792CarTo-HuUpdated Feb 27, 2023

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

An observational study in Immune Tolerance, sponsored by Hospices Civils de Lyon. Status unknown at 1 site in France. Per ClinicalTrials.gov, last updated 2023-02-27.

Sponsored by Hospices Civils de Lyon · Observational

The sponsor has not verified this record recently (last verified Feb 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
400
Sex
All
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Study 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).

02

Conditions studied

  • Immune Tolerance

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Keywords

  • PARANEOPLASTIC NEUROLOGICAL DISORDERS
  • LUNG CANCER
  • HU AUTOIMMUNITY
  • IMMUNE TOLERANCE BREAKDOWN
03

In context

Autoimmune Diseases

655 studies on the registry are indexed under Autoimmune Diseases; 275 are open to participants now.

This study's planned enrollment of 400 is above the median of 300 across 208 observational studies indexed under Autoimmune Diseases.

Browse Autoimmune Diseases studies →

Lead sponsor

Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients harboring Hu Abs in serum and/or CSF with or without cancer

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
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
400 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Patients with Hu Abs

    Patients harboring Hu Abs and a neurological syndrome

    Other: Description of clinical, immunological and tumor features of patients harboring Hu Abs

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.

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What researchers measure

Primary outcomes

  1. Modified Rankin Scale (mRs)

    Application of modified rankin scale

    Time frame: At 1 year

07

Study locations

1 site
  • Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes
    Lyon, 69677, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05745792
Lead sponsor
Hospices Civils de Lyon
Responsible party
Sponsor
First posted
Feb 27, 2023
Start date
Feb 1, 2022
Primary completion
Oct 1, 2022
Completion
Feb 1, 2025 (estimated)
Last update
Feb 27, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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