To hear about similar clinical trials, please enter your email below
Trial Title:
Clinico-immunological Characterization and Immune Tolerance Breakdown in HU-autoimmunity
NCT ID:
NCT05745792
Condition:
Immune Tolerance
Conditions: Official terms:
Autoimmune Diseases
Conditions: Keywords:
PARANEOPLASTIC NEUROLOGICAL DISORDERS
LUNG CANCER
HU AUTOIMMUNITY
IMMUNE TOLERANCE BREAKDOWN
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Other
Intervention name:
Description of clinical, immunological and tumor features of patients harboring Hu Abs
Description:
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 group label:
Patients with Hu Abs
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).
Criteria for eligibility:
Study pop:
Patients harboring Hu Abs in serum and/or CSF with or without cancer
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre de référence des syndromes neurologiques paranéoplasiques et encéphalites autoimmunes
Address:
City:
Lyon
Zip:
69677
Country:
France
Start date:
February 1, 2022
Completion date:
February 1, 2025
Lead sponsor:
Agency:
Hospices Civils de Lyon
Agency class:
Other
Source:
Hospices Civils de Lyon
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05745792
