First Observatory of Precocious Puberty.
ConditionPuberty, Precocious
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 11
SponsorHospices Civils de Lyon
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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)
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).
Disqualifiers
Consultation with the same investigator over the same period (same quarter) as a patient in the PP group
Family not speaking French, language barrier.
Trial population
Patients will be recruited in private heathlcare: 2880 patients distributed between the 2 following groups: PP (Precocious puberty group) and PA (Advanced puberty group), and 480 children in the control group.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
3,360 Participants
are grouped into 3 trial groupsGroup A: Precocious puberty group
Group B: Advanced puberty group
Group C: Control group
Trial outcomes
Primary outcomes
1
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).
Time frame
Up to 48 month2
Missing data rate
Missing data rate less than 10% for pubertal stage.
Time frame
Up to 48 month3
At least 75% of patients included
At least 75% of patients included compared to the number of eligible patients.
Time frame
Up to 48 monthSponsors and contacts
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Source ClinicalTrials.gov