Use of Omics Methods to Classify Variations of Uncertain Significance and Improve Diagnosis of Neurogenetic Diseases

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorUniversity Hospital, Rouen

About this trial

Many neurological disorders show a strong genetic basis, from hereditary diseases caused by a single mutation in a given gene, to diseases caused by combinations of strong genetic risk factors. However, even after the sequencing of the appropriate genes, a large proportion of patients remains undiagnosed, either because there is no candidate mutation observed, or in case of identification of a candidate mutation with insufficient knowledge to consider it as pathogenic or not.

The aim of this project is to identify the cause of neurogenetic diseases in patients in situations of diagnostic wandering or dead ends by proposing the analysis of RNA and/or proteins from different tissues.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

1a. Patient, major or minor, with a neurological disease affecting the central nervous system, who has already benefited from a genomic analysis (panel, exome or genome sequencing) as part of routine care, with inconclusive analysis because the result was either a variation of uncertain significance or the absence of a variant of interest (patients with inconclusive genomic results).

1b. Patient with neurological disease affecting the central nervous system, of confirmed monogenic or probable oligogenic cause (positive controls).

A relative of a type 1a. or 1b. patient with no symptoms of the disease, after the expected age of onset of symptoms in the patient's own family (healthy relatives).

Affiliation with a social security scheme

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • RNA and/or DNA methylation and/or protein analysis

    Genetic

    RNA and/or DNA methylation and/or protein analysis from a blood sample or another tissue including dedifferenciation into induced pluripotent stem cells

Treatment groups

95 Participants
are divided into 1 treatment group
Group A: ControlsOther 1 intervention

Trial outcomes

Primary outcomes

1

number and proportion of patients

number and proportion of patients in the "Patients with inconclusive results" group for whom a final diagnosis can be made at the end of this research.

Time frame
through study completion, an average of 5 years

Secondary outcomes

1

Inclusion

Inclusion of at least 50 participants with successful implementation of at least two procedures (see below, list of procedures)

Time frame
through study completion, an average of 5 years
2

Identification of at least one candidate biomarker linked to one or more abnormalities of a gene or group of genes.

Identification of at least one candidate biomarker linked to one or more abnormalities of a gene or group of genes.

Time frame
through study completion, an average of 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Rouen

Lead sponsor

University Hospital, Lille

Collaborator

Groupe Hospitalier Pitie-Salpetriere

Collaborator