An observational study in Neurodevelopmental Disorders and Intellectual Developmental Disorder, sponsored by Centre Hospitalier Universitaire de Besancon. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-04-14.
Sponsored by Centre Hospitalier Universitaire de Besancon · Observational
Despite technological advances, a genetic etiology has been identified in only about 50% to 60% of patients with Neurodevelopmental disorders (NDDs), with a higher diagnostic yield in the syndromic NDD and IDD subgroups. However, identifying a precise etiological diagnosis is essential to optimize patient care, clarify their prognosis, consider targeted therapies, refer families to appropriate resources and support, and provide genetic counseling to relatives. The tests typically offered as part of the etiological assessment of syndromic NDDs and IDD include DNA microarray analysis, testing for fragile X syndrome and genome sequencing from a blood sample. When this assessment remains negative, the cause usually remains unknown.
Mosaic genomic abnormalities (or post-zygotic variations) are a common cause of negative results in current diagnostic genetic tests and represent a field of research that has yet to be fully explored outside of skin disorders. Identifying mosaic genomic abnormalities remains technically complex due to the difficulty of detecting low levels of mosaicism and limited access to the tissue of interest when the variation is absent from blood tissue.
High-depth exome sequencing is the technique of choice for detecting low levels of mosaicism. In the case of NNDs, as the affected tissue is not available, the buccal epithelium is an interesting alternative to blood, as it is easily accessible and inexpensive.
The objective of our study is to evaluate the diagnostic yield of high-depth exome sequencing technology on a DNA extracted from a buccal swab in the etiological assessment of patients with IDD or syndromic NDD whose reference analysis (genome sequencing on blood) proved inconclusive.
387 studies on the registry are indexed under Intellectual Disability; 105 are open to participants now.
This study's planned enrollment of 50 is below the median of 150 across 125 observational studies indexed under Intellectual Disability.
Browse Intellectual Disability studies →Centre Hospitalier Universitaire de Besancon is the lead sponsor of 450 studies on the registry; 97 are open to participants now.
Compared within Intellectual Disability, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neurodevelopmental Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Men and women of all ages with syndromic neurodevelopmental disorder (NDD) or intellectual developmental disorder (IDD) and a trio genome sequencing on blood inconclusive
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Exclusion Criteria:
buccal swab
Identification of a defined genetic cause by demonstrating at least one variation of class 4 (probably pathogenic) or 5 (pathogenic) according to the ACMG classification explaining the patient's symptoms.
Time frame: 2 years
No study locations are listed for this record.
Plan to share: No
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This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Besancon →