ALICA
Sponsor study identifier
interventional
210
1 country
1
Study Start
December 11, 2024
Actual (reported)Primary Completion
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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. 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 11, 2024
Actual (reported)June 20, 2024
Actual (reported)December 11, 2024
Actual (reported)June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Identification of a causal genetic variant (class 4 or 5 variant - ACMG classification) that may explain the patients' symptoms.
Through study completion, on average of 18 months
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Chu Dijon Bourgogne
Dijon, 21000, France
First Submitted
June 11, 2024
First Posted
June 20, 2024
Study Start
December 11, 2024
Actual (reported)Primary Completion
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Study Completion
June 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
January 21, 2026
Record last verified: 2026-01
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Source: ClinicalTrials.gov.
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