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First Observatory of Precocious Puberty. (PAPPEL)

Civil Hospices of Lyon logo

Civil Hospices of Lyon

Status

Enrolling

Conditions

Puberty, Precocious

Study type

Observational

Funder types

Other

Identifiers

NCT06263868
2023-A02313-42 (Other Identifier)
69HCL23_1090

Details and patient eligibility

About

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.

Enrollment

3,360 estimated patients

Sex

All

Ages

Under 11 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

3,360 participants in 3 patient groups

Precocious puberty group
Description:
Girl \< 8 years old or boy \< 9 years old when the first signs of development appear.
Advanced puberty group
Description:
Girl aged ≥ 8 and \< 10 years or boy ≥ 9 and \< 11 years old when the first signs of development appear.
Control group
Description:
Boy or girl without any signs of puberty development (Tanner 1)

Trial contacts and locations

23

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Central trial contact

Emillie Doye, MD; Tiphanie GINHOUX

Data sourced from clinicaltrials.gov

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