NCT05858606 Multidisciplinary Evaluation and a Genome-wide Analysis in a Cohort of Idiopathic Short Stature Patients
| NCT ID | NCT05858606 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Montpellier |
| Condition | Idiopathic Short Stature |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-03-16 |
| Primary Completion | 2029-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 200 participants in total. It began in 2026-03-16 with a primary completion date of 2029-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This trial aims to evaluate the prevalence of idiopathic short stature among children whose growth is above -2,5SD (AFPA- CRESS/Inserm -CompuGroup Medical 2018 curve) or above -2SD of the parental target size (taking child gender into account), after exclusion of classical pediatric and endocrinologic pathologies, and to evaluate the prevalence of monogenic causes of idiopathic short stature. A two-step study will be performed. The first one consists in a standardized multidisciplinary clinico-radiological evaluation of those children to evaluate the real prevalence of idiopathic short stature (ISS) among these patients. The second step consists in performing a whole genome sequencing analysis in the 30 first patients for whom the diagnosis of ISS is confirmed.
Eligibility Criteria
Inclusion Criteria: * Children aged 4 to 18 years * 2 sexes * Height less than -2.5DS (standard deviations of the AFPA- CRESS/Inserm -CompuGroup Medical 2018 curve) or less than -2DS of the TCP (parental target height, corresponding to the average of parental heights +6.5 cm in boys, -6.5 cm in girls) * Normal karyotype + FISH SHOX for girls * Previously performed:celiac disease antibodies, WBC-platelets, CRP, blood ionogram, creatinine, blood calcium, blood phosphorus, ASAT, ALAT, PAL, PTH, TSH, T4L, growth hormone test normal according to the standards of the laboratory of the CHU of Montpellier * Acceptance of X-rays, in addition to those already performed as part of the care, which will not be repeated if necessary: spine front and profile, pelvis front, 1 upper limb front, 1 lower limb front F, hands and feet front * Acceptance of photographs: whole body with underwear, face face and profile, 2 faces of hands; feet, face * Acceptance of blood samples for the child and the 2 parents (trio) * Consent signed by both parents Exclusion Criteria: * Intellectual disability (IQ below 70) * Cardiac, renal, digestive or cerebral malformation, cleft lip or palate, hearing or visual impairment, epilepsy * Renal or cardiac insufficiency, digestive or chronic inflammatory pathology * Previously established genetic diagnosis
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05858606 clinical trial?
This trial is open to participants of all sexes, aged 4 Years or older, up to 18 Years, studying Idiopathic Short Stature. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05858606 currently recruiting?
Yes, NCT05858606 is actively recruiting participants. Contact the research team at m-willems@chu-montpellier.fr for enrollment information.
Where is the NCT05858606 trial being conducted?
This trial is being conducted at Montpellier, France.
Who is sponsoring the NCT05858606 clinical trial?
NCT05858606 is sponsored by University Hospital, Montpellier. The trial plans to enroll 200 participants.