Clinical-immunological Features of DNER Ataxia (CLIMDA)

February 4, 2022 updated by: Hospices Civils de Lyon
Using a retrospective cohort of 34 patients with DNER ataxia, we will characterize clinical presentation, tumor associations, and outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bron, France
        • Recruiting
        • HCL Hôpital Neurologique / Groupement EST

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with DNER antibodies

Description

Inclusion Criteria:

  • Patient > 18 years old
  • Patient with neurological disorder
  • Patient with DNER antibodies in sera or CSF

Exclusion Criteria:

  • - No available clinical data
  • Patient without DNER antibodies or neurological disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
DNER ataxia
Patients with well-characterized DNER antibodies.
Genetic: Description of clinical characteristic and genetic tumors
This is a non-interventional study involving clinical data and biological samples (DNA). Clinical data are collected for the center and samples are already stored in biobank repositories and collected as part of "good clinical practice" in the diagnostic process of patients with suspected autoimmune encephalitis, meaning that the standard diagnostic and therapeutic approaches will not be altered in the selected study population. Patients have already gave explicit written consent for biological specimens sampling and storage at the "Centre de Ressources Biologiques des Hospices Civils de Lyon" (CRB-HCL) (including tissue, cells or biological fluids) and genetic analysis for research purposes. Additionally, patients will be informed about the present study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Rankin scale (mRS)
Time Frame: 6 month after the beginning of study
Residual neurological disability as assessed by the modified Rankin scale (mRS) score at last visit)
6 month after the beginning of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 15, 2021

Primary Completion (ACTUAL)

December 15, 2021

Study Completion (ANTICIPATED)

June 1, 2022

Study Registration Dates

First Submitted

January 25, 2022

First Submitted That Met QC Criteria

February 4, 2022

First Posted (ACTUAL)

February 7, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 7, 2022

Last Update Submitted That Met QC Criteria

February 4, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 497

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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