NCT06660108: TSLO

MOLECULAR BASIS OF LANGUAGE DEVELOPMENT AND ASSOCIATED DISORDERS

Recruiting now NA Last updated 4 April 2025

What this trial tests

NA trial testing blood draw in Developmental Language Disorder in 50 participants. Currently enrolling.

Timeline

25 March 2025

Primary endpoint
25 March 2025

25 March 2028

Quick facts

Lead sponsor	Institut National de la Santé Et de la Recherche Médicale, France
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	50
Start date	25 March 2025
Primary completion	25 March 2025
Estimated completion	25 March 2028
Sites	3 locations across France

Drugs / interventions tested

• blood draw — full drug profile →

Conditions studied

• Developmental Language Disorder — all drugs for Developmental Language Disorder →

Sponsor

Institut National de la Santé Et de la Recherche Médicale, France — full company profile →

Who can join

5 and older, any sex, with Developmental Language Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Developmental Language Disorder (DLD) refers to children who present with language difficulties that are not due to a known biomedical condition or associated with autism spectrum disorder (ASD) or intellectual disability. The prevalence of DLD is \~7%-8% or 2% if severe forms are considered.

However, the clinical heterogeneity of language disorders, the presence of co-morbidities and the inconsistent terminology used for many years have hindered research and clinical practice. Distinguishing sub-groups of children with language problems is crucial when tackling the underlying genetic causes of this disease. Recently, several studies using high-throughput sequencing have better define the genetic basis of CAS but such studies focusing on DLD are limited. The investigation of more homogeneous cohorts of individuals that clearly distinguish DLD cases, from ID and not including children with CAS should improve our understanding of the genetic basis of this disorder.

In this study, we aim to built and investigate a well-characterized cohort of DLD patients using pangenomic approaches to better define the molecular basis of this disorder. All individuals will be analyzed using chromosomal microarray analysis and whole genome sequencing. Multiple observations and preliminary results suggest strong links with the genetic basis of other neurodevelopmental disorders.

The goal is to identify CNV or SNV as causative allele or risk factor and already known to be involved in other neurodevelopmental disorders as well as potential new variants.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Deciphering the genetic basis of developmental language disorder in children without intellectual disability, autism or apraxia of speech.
   Ormieres C, Lesieur-Sebellin M, Siquier-Pernet K, Delplancq G, et al · · 2025 · cited 3× · PMID 39948625 · DOI 10.1186/s13229-025-00642-8