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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06325878
Other study ID # NEU2-OSS-2022-001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 15, 2022
Est. completion date December 31, 2025

Study information

Verified date March 2024
Source Istituto Clinico Humanitas
Contact Pietro Emiliano Emiliano Doneddu, MD
Phone 00390282247761
Email pietro.doneddu@hunimed.eu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to characterize the genetic architecture of a large cohort of CIDP patients to evaluate whether specific alleles/haplotypes are implicated in the risk of CIDP, in its clinical and immunological variability, severity, therapeutic response, and association with diabetes and other autoimmune diseases. We will genotype >700,000 single nucleotide polymorphisms (SNPs) by using the Illumina Global Screening Array (GSA), of approximately 1000 patients with CIDP. About 3500 healthy controls from the Italian population have been already genotyped using GWAS from our genetic department. Alleles/haplotypes will be also compared between patients with typical CIDP and its variants, between CIDP patients with and without specific antibodies, between CIDP patients with and without comorbidities, between CIDP patients with low and high levels of disability and between CIDP patients with and without response to each individual treatment (IVIg, steroids, plasma exchange)


Description:

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Study Design


Related Conditions & MeSH terms

  • Chronic Inflammatory Demyelinating Polyradiculoneuropathy
  • Polyradiculoneuropathy
  • Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

Intervention

Genetic:
Genome-wide association study
Alleles/haplotypes evidence through GWAS will be compared between patients with CIDP and control subjects without CIDP

Locations

Country Name City State
Italy IRCCS Istituto Clinico Humanitas Rozzano

Sponsors (1)

Lead Sponsor Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary single nucleotide polymorphisms (SNPs) Differences in single nucleotide polymorphisms (SNPs) between CIDP patients and controls 3 years
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