Puberty, Precocious Clinical Trial
— PAPPELOfficial title:
First Observatory of Precocious and Advanced Puberty in Private Healthcare.
The age of puberty has fluctuated throughout history. Recent data shows an increase in the age of onset of puberty signs, in the United States but also in Europe. A recent Public Health France study published in 2018 reports an increase in the incidence of precocious puberty with geographical heterogeneity. The consequences of these appearances include the early onset of menarche, short adult height and the psychological impact. Due to a lack of studies and additional data, the reasons for this development are difficult to understand. Among current hypotheses, the entanglement with the evolution of our environment is at the forefront: the action of environmental endocrine disruptors and nutritional factors could play a role in the process of early appearance of pubertal signs. The establishment of a national observatory for early and advanced puberty in collaboration with pediatric endocrinologists (on the front line) would allow a reliable and precise field approach, capable of supplementing epidemiological data, which are currently insufficient. The investigators hypothesize that the establishment of an observatory of pubertal advances (early puberty and advanced puberty) in private medicine is possible, with inclusion of at least 75% of eligible patients, and collection of at least 80% of data.
Status | Not yet recruiting |
Enrollment | 3360 |
Est. completion date | March 1, 2028 |
Est. primary completion date | March 1, 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 11 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
France | Pediatric practice | Aix-en-Provence | Provence-Alpes-Côte d'Azur |
France | Hôpital Femme Mère Enfant, Hospices civils de Lyon | Bron | |
France | Pediatric practice | Chambray-lès-Tours | Centre-Val De Loire |
France | Clinique du Val d'Ouest | Ecully | Auvergne-Rhône-Alpes |
France | Clinique du Val d'Ouest | Ecully | Auvergne-Rhône-Alpes |
France | Clinique du Val d'Ouest | Ecully | Auvergne-Rhône-Alpes |
France | Pediatric practice | Essey-lès-Nancy | Grand Est |
France | Pediatric practice | Fondettes | Indre-et-Loire |
France | Pediatric practice | Levallois-Perret | Hauts-de-Seine |
France | Polyclinique Bordeaux rive droite | Lormont | Nouvelle-Aquitaine |
France | Clinique Saint jean | Lyon | Auvergne-Rhône-Alpes |
France | Pediatric practice | Lyon | Auvergne-Rhône-Alpes |
France | Pediatric practice | Marseille | Provence-Alpes-Côte d'Azur |
France | Pediatric practice | Marseille | Provence-Alpes-Côte-d'Azur |
France | Pediatric practice | Nice | Provence-Alpes-Côte d'Azur |
France | Pediatric practice | Paris | Île-De-France |
France | Pediatric practice | Paris | Île-De-France |
France | Pediatric practice | Paris | Île-De-France |
France | Pediatric practice | Paris | Ile-de-France |
France | Pediatric practice | Pau | Nouvelle-Aquitaine |
France | Pediatric Practice | Pessac | Nouvelle-Aquitaine |
France | Pediatric practice | Rennes | Bretagne |
France | Pediatric practice | Saint-Nazaire | Pays De La Loire |
France | Clinique rive gauche | Toulouse | Occitanie |
France | Pediatric practice | Trélazé | Pays De La Loire |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of recruited patients with at least 80% of the main data collected | Number of recruited patients with at least 80% of the main data collected (weight, height, BMI, pubertal stage, date of onset of pubertal signs, questionnaires). | Up to 48 month | |
Primary | Missing data rate | Missing data rate less than 10% for pubertal stage. | Up to 48 month | |
Primary | At least 75% of patients included | At least 75% of patients included compared to the number of eligible patients. | Up to 48 month |
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