NCT06263868

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,360

participants targeted

Target at P75+ for all trials

Timeline
26mo left

Started Jun 2024

Longer than P75 for all trials

Geographic Reach
1 country

25 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Jun 2024Jun 2028

First Submitted

Initial submission to the registry

February 9, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 16, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

June 26, 2024

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 26, 2028

Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

4 years

First QC Date

February 9, 2024

Last Update Submit

January 15, 2026

Conditions

Puberty, Precocious

Keywords

Early/precocious pubertyadvanced pubertynational observatoryprivate medicinefeasibility

Outcome Measures

Primary Outcomes (3)

  • 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

  • Missing data rate

    Missing data rate less than 10% for pubertal stage.

    Up to 48 month

  • At least 75% of patients included

    At least 75% of patients included compared to the number of eligible patients.

    Up to 48 month

Study Arms (3)

Precocious puberty group

Girl \< 8 years old or boy \< 9 years old when the first signs of development appear.

Advanced puberty group

Girl aged ≥ 8 and \< 10 years or boy ≥ 9 and \< 11 years old when the first signs of development appear.

Control group

Boy or girl without any signs of puberty development (Tanner 1)

Eligibility Criteria

AgeUp to 11 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study 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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Clinique du Val d'Ouest

Écully, Auvergne-Rhône-Alpes, 69130, France

RECRUITING

Clinique du Val d'Ouest

Écully, Auvergne-Rhône-Alpes, 69130, France

RECRUITING

Clinique du Val d'Ouest

Écully, Auvergne-Rhône-Alpes, 69130, France

RECRUITING

Pediatric practice

Lyon, Auvergne-Rhône-Alpes, 69006, France

RECRUITING

Pediatric practice

Rennes, Brittany Region, 35200, France

RECRUITING

Pediatric practice

Chambray-lès-Tours, Centre-Val de Loire, 37170, France

RECRUITING

Pediatric practice

Essey-lès-Nancy, Grand Est, 54270, France

RECRUITING

Pediatric practice

Levallois-Perret, Hauts-de-Seine, 92300, France

ACTIVE NOT RECRUITING

Pediatric practice

Fondettes, Indre-et-Loire, 37230, France

RECRUITING

Polyclinique Bordeaux rive droite

Lormont, Nouvelle-Aquitaine, 33310, France

ACTIVE NOT RECRUITING

Pediatric practice

Pau, Nouvelle-Aquitaine, 64000, France

RECRUITING

Pediatric Practice

Pessac, Nouvelle-Aquitaine, 33600, France

RECRUITING

Clinique rive gauche

Toulouse, Occitanie, 31300, France

NOT YET RECRUITING

Pediatric practice

Saint-Nazaire, Pays de la Loire Region, 44600, France

NOT YET RECRUITING

Pediatric practice

Aix-en-Provence, 13090, France

RECRUITING

Hôpital Femme Mère Enfant, Hospices civils de Lyon

Bron, 69677, France

RECRUITING

Pediatric practice

Marseille, 13008, France

ACTIVE NOT RECRUITING

Pediatric practice

Marseille, 13012, France

RECRUITING

Pediatric practice

Nice, 06000, France

RECRUITING

Clinique Saint jean

Saint-Jean-de-Védas, 34430, France

ACTIVE NOT RECRUITING

Pediatric practice

Trélazé, 49800, France

RECRUITING

Pediatric practice

Paris, Île-de-France Region, 75010, France

RECRUITING

Pediatric practice

Paris, Île-de-France Region, 75011, France

RECRUITING

Pediatric practice

Paris, Île-de-France Region, 75017, France

RECRUITING

Pediatric practice

Paris, Île-de-France Region, 75116, France

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Puberty, Precocious

Condition Hierarchy (Ancestors)

Gonadal DisordersEndocrine System Diseases

Study Officials

  • Emillie DOYE, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emillie Doye, MD

CONTACT

0472118890emilie.doye@chu-lyon.fr

Tiphanie GINHOUX

CONTACT

0427857723Tiphanie.ginhoux01@chu-lyon.fr

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2024

First Posted

February 16, 2024

Study Start

June 26, 2024

Primary Completion (Estimated)

June 26, 2028

Study Completion (Estimated)

June 26, 2028

Last Updated

January 16, 2026

Record last verified: 2026-01

Locations

FR(25)