Clinical Research Directory

Basal LH Threshold for the Diagnosis of Central Precocious Puberty

This retrospective monocentric observational study aims to evaluate whether basal luteinizing hormone (LH) levels can reliably diagnose central precocious puberty and reduce the need for LHRH stimulation testing. Currently, all patients with suspected precocious puberty undergo LHRH testing regardless of basal LH levels. The study will analyze pediatric patients evaluated between 2019 and 2024 to determine an optimal basal LH threshold with high specificity. Secondary analyses will assess diagnostic performance and explore clinical and biological factors influencing LH levels. The results may help reduce unnecessary testing and improve diagnostic strategies.

INSL3 as a Biomarker of Pubertal Activation: Role in Evaluating Precocious and Delayed Puberty

This is an observational study in children up to 16 years old who are suspected of having central precocious puberty or delayed puberty. The main questions it aims to answer are: * Can the level of insulin-like peptide 3 (INSL3) predict if a child's puberty has truly started? * Can this marker help reduce the need for more complex and invasive tests? Participants will: * Give one extra blood sample just before starting the standard gonadotropin-releasing hormone (GnRH) stimulation test (during the baseline blood draw). * Have this extra sample used to measure the INSL3 hormone. * Complete the rest of the GnRH test as prescribed by their doctor. Researchers will compare the INSL3 hormone levels in children who have a positive GnRH test to those who have a negative test. This will help researchers learn if INSL3 can be used as a new, simple tool to diagnose early or delayed puberty.

Hypiend - Multicomponent Behavioral Intervention in Pre-puberal Children (Hypiend-PPC)

This study is part of the European Hypiend project, which aims to explore the effects of co-exposure to endocrine-disrupting chemicals (EDCs) on the function and epigenetic programming of the hypothalamic-pituitary-adrenal (HPA) axis in order to define intervention strategies to minimize exposure and its consequences on the neuroendocrine system during the perinatal and prepubertal phases. The intervention during the perinatal phase is registered under the Unique Protocol ID: 101137440 - Hypiend - Clinical study to evaluate the effectiveness of a multicomponent behavioural intervention to reduce EDC exposure during the perinatal period in women and their offspring. The intervention presented here concerns the prepubertal phase. The primary objective is to demonstrate that a multi-component behavioral intervention (MBI) implemented in primary schools in two different European countries over two and a half school years is effective in reducing the presence of EDCs in the urine of prepubertal children, using the Health Action Process Approach (HAPA) and the Positive Behaviour Support (PBS) models to improve the intervention and parents' knowledge of these contaminants, as well as to advance scientific knowledge.