Observing early and advanced puberty in children
First Observatory of Precocious and Advanced Puberty in Private Healthcare.
This study is trying to understand how common early and advanced puberty is in children and what might be causing it by collecting information from pediatric specialists.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3360 (estimated) |
| Ages | N/A to 11 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 25 sites (Écully, Auvergne-Rhône-Alpes and 24 other locations) |
| Trial ID | NCT06263868 on ClinicalTrials.gov |
What this trial studies
This observational study aims to establish a national observatory for precocious and advanced puberty, focusing on children who show early signs of puberty. It will involve pediatric endocrinologists to gather reliable data on the incidence and potential causes of early puberty, including environmental and nutritional factors. The study will categorize participants into groups based on their puberty status and will include a control group for comparison. By collecting and analyzing this data, the study seeks to better understand the trends and implications of early puberty.
Who should consider this trial
Good fit: Ideal candidates include children suspected of having precocious or advanced puberty, specifically girls under 8 years and boys under 9 years for precocious puberty, and girls aged 8-10 years and boys aged 9-11 years for advanced puberty.
Not a fit: Patients who do not exhibit any signs of pubertal development and do not meet the age criteria for the study will not benefit from participation.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the causes and consequences of precocious puberty, leading to improved management and treatment strategies for affected children.
How similar studies have performed: While there is limited data on similar observatories, the approach of gathering comprehensive data on precocious puberty is relatively novel and could fill a significant gap in current understanding.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Precocious puberty group (PP) : * Suspected precocious puberty (girl aged \< 8 years or boy aged \< 9 years when the first signs of development\* appear) * Suspected precocious puberty (girl aged \< 8 years or boy aged \< 9 years when the first signs of development\* appear) Advanced puberty group (AP) : * Suspected advanced puberty (girl aged ≥ 8 and \< 10 years or boy aged ≥ 9 and \< 11 years when the first signs of development\* appear) * First consultation with the investigator (pediatric endocrinologist). Control group : * Boy or girl without signs of pubertal development (Tanner 1); * Matched to the PP group on sex and age (+/- 1 year); * Consultation with the same investigator over the same period (same quarter) as a patient in the PP group Exclusion Criteria: All groups * Consultation with the same investigator over the same period (same quarter) as a patient in the PP group * Family not speaking French, language barrier.
Where this trial is running
Écully, Auvergne-Rhône-Alpes and 24 other locations
- Clinique du Val d'Ouest — Écully, Auvergne-Rhône-Alpes, France (Recruiting)
- Clinique du Val d'Ouest — Écully, Auvergne-Rhône-Alpes, France (Recruiting)
- Clinique du Val d'Ouest — Écully, Auvergne-Rhône-Alpes, France (Recruiting)
- Pediatric practice — Lyon, Auvergne-Rhône-Alpes, France (Recruiting)
- Pediatric practice — Rennes, Brittany Region, France (Recruiting)
- Pediatric practice — Chambray-lès-Tours, Centre-Val de Loire, France (Recruiting)
- Pediatric practice — Essey-lès-Nancy, Grand Est, France (Recruiting)
- Pediatric practice — Levallois-Perret, Hauts-de-Seine, France (Active_not_recruiting)
- Pediatric practice — Fondettes, Indre-et-Loire, France (Recruiting)
- Polyclinique Bordeaux rive droite — Lormont, New Aquitaine, France (Active_not_recruiting)
- Pediatric practice — Pau, New Aquitaine, France (Recruiting)
- Pediatric Practice — Pessac, New Aquitaine, France (Recruiting)
- Clinique rive gauche — Toulouse, Occitanie, France (Not_yet_recruiting)
- Pediatric practice — Saint-Nazaire, Pays de la Loire Region, France (Not_yet_recruiting)
- Pediatric practice — Aix-en-Provence, France (Recruiting)
- Hôpital Femme Mère Enfant, Hospices civils de Lyon — Bron, France (Recruiting)
- Pediatric practice — Marseille, France (Active_not_recruiting)
- Pediatric practice — Marseille, France (Recruiting)
- Pediatric practice — Nice, France (Recruiting)
- Clinique Saint jean — Saint-Jean-de-Védas, France (Active_not_recruiting)
- Pediatric practice — Trélazé, France (Recruiting)
- Pediatric practice — Paris, Île-de-France Region, France (Recruiting)
- Pediatric practice — Paris, Île-de-France Region, France (Recruiting)
- Pediatric practice — Paris, Île-de-France Region, France (Recruiting)
- Pediatric practice — Paris, Île-de-France Region, France (Active_not_recruiting)
Study contacts
- Principal investigator: Emillie DOYE, MD — Hospices Civils de Lyon
- Study coordinator: Emillie Doye, MD
- Email: emilie.doye@chu-lyon.fr
- Phone: 0472118890
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.