CarTo-Hu: Clinico-immunological Characterization and Immune Tolerance Breakdown in HU-autoimmunity

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05745792

Collaborator

(none)

400

Enrollment

Location

Anticipated Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Immune Tolerance	Other: Description of clinical, immunological and tumor features of patients harboring Hu Abs

Study Design

Study Type:

Observational

Anticipated Enrollment :

400 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Feb 1, 2022

Actual Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Feb 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
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 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.

Arm

Intervention/Treatment

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

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.

Outcome Measures

Primary Outcome Measures

Modified Rankin Scale (mRs) [At 1 year]
Application of modified rankin scale

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes	Lyon		France	69677

Sponsors and Collaborators

Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hospices Civils de Lyon

ClinicalTrials.gov Identifier:

NCT05745792

Other Study ID Numbers:

First Posted:

Feb 27, 2023

Last Update Posted:

Feb 27, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Hospices Civils de Lyon

PARANEOPLASTIC NEUROLOGICAL DISORDERS

LUNG CANCER

HU AUTOIMMUNITY

IMMUNE TOLERANCE BREAKDOWN

Additional relevant MeSH terms:

Autoimmune Diseases

Study Results

No Results Posted as of Feb 27, 2023