ClinicalTrials.gg
Not yet recruitingNCT07492199SEPASAUpdated Apr 14, 2026

High Depth Exome Sequencing on DNA From a Salivary Sample by Mouth Smear.

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.

Primary conditionIntellectual DisabilityRegistry: Neurodevelopmental DisordersReclassifiedWhy we changed it
Registry
Neurodevelopmental Disorders — the first condition term the registry derived for this study.
ClinicalTrials.gg
Intellectual Disability
Why
  1. The study's title name Intellectual Disability, a narrower term within Neurodevelopmental Disorders.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Centre Hospitalier Universitaire de Besancon · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Sex
All
01

Study summary

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.

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Conditions studied

  • Neurodevelopmental Disorders
  • Intellectual Developmental Disorder

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03

In context

Intellectual Disability Reclassified

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 →

Lead sponsor

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 →

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Men and women of all ages with syndromic neurodevelopmental disorder (NDD) or intellectual developmental disorder (IDD) and a trio genome sequencing on blood inconclusive

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient with syndromic neurodevelopmental disorder (NDD) or intellectual developmental disorder (IDD)
  • Trio genome sequencing on blood inconclusive
  • Men and women
  • All ages
  • No objection to participating in the study
  • Affiliation with a French social security system or beneficiary of such a system

Exclusion criteria

Exclusion Criteria:

  • Pregnant women and nursing mothers
  • Persons deprived of their liberty by judicial or administrative decision; persons undergoing compulsory psychiatric care; persons admitted to a health or social care facility for purposes other than research
  • Subjects who are in the exclusion period of another study or listed in the "national volunteer registry"
  • Genetic cause identified in the preliminary etiological assessment
  • Phenocopy: other likely non-genetic cause of TND (perinatal anoxia, infection, trauma, etc.)
  • Patients without health insurance
  • Patients unlikely to cooperate with the study and/or anticipated low cooperation by the investigator
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testgenetic

    buccal swab

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What researchers measure

Primary outcomes

  1. 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

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07492199
Responsible party
Sponsor
First posted
Mar 25, 2026
Start date
Apr 1, 2026 (estimated)
Primary completion
Apr 1, 2028 (estimated)
Completion
Apr 1, 2029 (estimated)
Last update
Apr 14, 2026

Study contacts

Juliette PIARD, Pr
Contact
jpiard@chu-besancon.fr
33381218187

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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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Discussion

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