DNER AtaxiaCLIMDANCT05225896
Clinical-immunological Features of DNER Ataxia
An observational study of DNER Ataxia, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Using a retrospective cohort of 34 patients with DNER ataxia, we will characterize clinical presentation, tumor associations, and outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DNER Ataxia
- What is being tested?
- Description of clinical characteristic and genetic tumors
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 15 Jun 2021to Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with DNER antibodies
Who may be able to join
- Patient > 18 years old
- Patient with neurological disorder
- Patient with DNER antibodies in sera or CSF
Who cannot join
- - No available clinical data
- Patient without DNER antibodies or neurological disorder
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
HCL Hôpital Neurologique / Groupement EST
Bron
About this study
Using a retrospective cohort of 34 patients with DNER ataxia, we will characterize clinical presentation, tumor associations, and outcomes.
- Conditions
- DNER Ataxia
- Being tested
- Description of clinical characteristic and genetic tumors
- Keywords
- DNER antibodies, autoimmune cerebellar ataxia, Hodgkin lymphoma
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Description of clinical characteristic and genetic tumorsGenetic
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.
| Study group | Role | What they receive |
|---|---|---|
| DNER ataxia | Patients with well-characterized DNER antibodies. Receives: Genetic: Description of clinical characteristic and genetic tumors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin scale (mRS)
Residual neurological disability as assessed by the modified Rankin scale (mRS) score at last visit)
Measured: 6 month after the beginning of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start15 Jun 2021
- Primary completion15 Dec 2021
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DNER AtaxiaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05225896
- Sponsor's protocol ID
- 497
- Acronym
- CLIMDA
- Status last verified
- Feb 2022
- First submitted
- 25 Jan 2022
- Last updated
- 7 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical-immunological Features of DNER Ataxia
- ClinicalTrials.gov ID
- NCT05225896
- Acronym / sponsor ID
- CLIMDA / 497
- Conditions
- DNER Ataxia
- Keywords
- DNER antibodies, autoimmune cerebellar ataxia, Hodgkin lymphoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 15 Jun 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- Jun 2022 (estimated)
- First posted
- 7 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Using a retrospective cohort of 34 patients with DNER ataxia, we will characterize clinical presentation, tumor associations, and outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DNER ataxia | – | Genetic: Description of clinical characteristic and genetic tumorsPatients with well-characterized DNER antibodies. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with DNER antibodies
Key inclusion criteria (3 listed)
- Patient > 18 years old
- Patient with neurological disorder
- Patient with DNER antibodies in sera or CSF
Key exclusion criteria (2 listed)
- - No available clinical data
- Patient without DNER antibodies or neurological disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Description of clinical characteristic and genetic tumorsThis 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. | Genetic | DNER ataxia |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of DNER Ataxia, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bastien JOUBERT, MD (04.27.85.54.60, bastien.joubert@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Rankin scale (mRS) (time frame: 6 month after the beginning of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.