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Cerebellar AtaxiasALICANCT06467175

The Benefits of Long-read High-throughput Genomic Sequencing for the Causal Diagnosis of Cerebellar Ataxias

A study testing blood sampling for high molecular weight DNA extraction in people with Cerebellar Ataxias, run by Centre Hospitalier Universitaire Dijon at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Cerebellar ataxias are a group of rare neurological disorders that are clinically and genetically heterogeneous, with several hundred genes and diseases known to date. Over the last decade, their diagnosis has been revolutionised by the development of high-throughput sequencing technologies such as exome/genome… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Cerebellar Ataxias
What is being tested?
blood sampling for high molecular weight DNA extraction
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
1 siteFrance
Study dates
11 Dec 2024to Jun 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Index case with progressive cerebellar ataxia of familial form (> 1 1st or 2nd degree relative affected) or sporadic form (onset of symptoms before age 50)
  • Index case having undergone srGS and not having obtained a molecular diagnosis, whose srGS data are available for reanalysis.
  • Ability to understand and sign consent by the index case and his/her relative(s) (up to a maximum of 2)
  • Sample may be taken from the index case and at least one affected or healthy* first-degree relative (parent, sibling) * Healthy relatives must be older than the patient to avoid conducting a presymptomatic test in subjects who consider themselves to be healthy.

Who cannot join

  • Index case or relative(s) not affiliated to national health insurance;
  • Index case and his/her parents presenting a condition that, in the opinion of the investigator, would contraindicate the subject's participation in the study.
  • Person under legal protection (curatorship, guardianship)
  • Person subject to a measure of legal protection
  • Pregnant, parturient or breast-feeding women
  • An adult who is unable to give consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

France1 site, 1 recruiting
  • Chu Dijon Bourgogne

    Dijon, 21000

    Quentin THOMAS, 0380295313 ext. +33, quentin.thomas@chu-dijon.fr

    Recruiting

Other trials in France

About this study

Cerebellar ataxias are a group of rare neurological disorders that are clinically and genetically heterogeneous, with several hundred genes and diseases known to date. Over the last decade, their diagnosis has been revolutionised by the development of high-throughput sequencing technologies such as exome/genome sequencing (ES/GS), making it possible to obtain a molecular diagnosis in a growing number of patients. However, almost 40% of patients remain without a molecular diagnosis, raising questions about the limitations of sequencing technologies based on a technique known as short-read. One limitation of short-read is its poor ability to detect repeated motif expansions, a frequent mechanism in neurology and associated with more than thirty neurogenetic diseases. Although tools for analysing ES/GS data have gradually been developed in response to this problem, their effectiveness and reliability remain moderate. To date, the gold standard for detecting these expansions remains targeted approaches such as PCR and Southern blot, which are long, tedious and costly processes that require an independent search for each expansion, forcing clinicians to select expansions and limiting diagnostic yield. In addition, there are diseases associated with expansions so rare that no French laboratory offers a diagnostic test.

The recent development of long fragment genome sequencing (long-read - lrGS) could provide a solution to all these problems. These technologies are based on a sequencing process during which DNA is preserved in the form of large molecules of several tens of thousands of bases. Regions of the genome containing expansions can therefore be studied directly in their entirety, avoiding the difficulties of reconstruction from small fragments, which is the case in short-read sequencing. In addition, lrGS can characterize the size of repeated motifs and thus detect any causal expansion in an individual in a single analysis.

Read more

A number of recently published studies, particularly in neurology, have demonstrated the ability of lrGS to detect pathologies with known expansions (SCA36, C9ORF72), but also to discover new ones and thus explain the molecular basis of rare pathologies (SCA27b, NOTCH2NLC). Although these sequencing technologies have been around for a number of years, access is still restricted to research work and is limited by their higher cost.

Their value as a second-line diagnostic tool has yet to be demonstrated. The investigators propose to evaluate the feasibility and diagnostic yield of Oxford Nanopore lrGS in duo or trio (patients + 1 or 2 first-degree relatives) in patients with cerebellar ataxia without molecular diagnosis after short-read GS. This will be the first study to transfer this lrGS technique to the second line, in real-life conditions, for the causal genetic diagnosis of cerebellar ataxia.

Being tested
blood sampling for high molecular weight DNA extraction
Medical subject headings
Cerebellar Ataxia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • blood sampling for high molecular weight DNA extractionBiological

    2 EDTA tubes will be taken for the index case, and the DNA will be extracted for sequencing into long-fragments and short-fragments. 1 EDTA tube will be taken for each relative.

Study groups in NCT06467175
Study groupRoleWhat they receive
cax index with 1 to 2 relativesExperimentalNot described
Receives: Biological: blood sampling for high molecular weight DNA extraction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Identification of a causal genetic variant (class 4 or 5 variant - ACMG classification) that may explain the patients' symptoms.

    Measured: Through study completion, on average of 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2024
  2. Study start11 Dec 2024
  3. Primary completionJun 2028 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06467175
Sponsor's protocol ID
THOMAS PHRCI 2022
Acronym
ALICA
Status last verified
Jan 2026
First submitted
11 Jun 2024
Last updated
21 Jan 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing blood sampling for high molecular weight DNA extraction in people with Cerebellar Ataxias, run by Centre Hospitalier Universitaire Dijon 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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 21 Jan 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Quentin THOMAS (0380295313 ext. +33, quentin.thomas@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identification of a causal genetic variant (class 4 or 5 variant - ACMG classification) that may explain the patients' symptoms. (time frame: Through study completion, on average of 18 months). 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 21 Jan 2026.

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