First Observatory of Precocious Puberty. (PAPPEL)

February 16, 2024 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

3360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bron, France, 69677
        • Hôpital Femme Mère Enfant, Hospices civils de Lyon
        • Principal Investigator:
          • Emilie Doye, MD
        • Contact:
    • Auvergne-Rhône-Alpes
      • Ecully, Auvergne-Rhône-Alpes, France, 69130
        • Clinique du Val d'Ouest
        • Contact:
        • Principal Investigator:
          • Mélanie Daval Cote, MD
      • Lyon, Auvergne-Rhône-Alpes, France, 69006
        • Pediatric practice
        • Contact:
        • Principal Investigator:
          • Prisca DEALBERTI, MD
      • Lyon, Auvergne-Rhône-Alpes, France, 69008
        • Clinique Saint Jean
        • Contact:
        • Principal Investigator:
          • Aude Mariani Ecochard, MD
    • Bretagne
      • Rennes, Bretagne, France, 35200
        • Pediatric practice
        • Contact:
        • Principal Investigator:
          • Livie CHATELAIS, MD
    • Centre-Val De Loire
      • Chambray-lès-Tours, Centre-Val De Loire, France, 37170
        • Pediatric practice
        • Contact:
        • Principal Investigator:
          • Caroline HASSELMAN, MD
    • Grand Est
      • Essey-lès-Nancy, Grand Est, France, 54270
        • Pediatric practice
        • Contact:
        • Principal Investigator:
          • Julie AUGER, MD
    • Hauts-de-Seine
      • Levallois-Perret, Hauts-de-Seine, France, 92300
        • Pediatric practice
        • Contact:
        • Principal Investigator:
          • Delphine ZENATY, MD
    • Ile-de-France
      • Paris, Ile-de-France, France, 75116
        • Pediatric practice
        • Contact:
        • Principal Investigator:
          • Mélanie AMOUYAL, MD
    • Indre-et-Loire
      • Fondettes, Indre-et-Loire, France, 37230
        • Pediatric practice
        • Contact:
        • Principal Investigator:
          • Myriam BOUILLO, MD
    • Nouvelle-Aquitaine
      • Lormont, Nouvelle-Aquitaine, France, 33310
        • Polyclinique Bordeaux rive droite
        • Contact:
        • Principal Investigator:
          • Aurélie LACOSTE RODRIGUE, MD
      • Pau, Nouvelle-Aquitaine, France, 64000
        • Pediatric practice
        • Contact:
        • Principal Investigator:
          • Catie CESSANS, MD
      • Pessac, Nouvelle-Aquitaine, France, 33600
        • Pediatric practice
        • Contact:
          • Olivier PUEL, MD
          • Phone Number: 33 0556453585
          • Email: opuel@free.fr
        • Principal Investigator:
          • Olivier PUEL, MD
    • Occitanie
      • Toulouse, Occitanie, France, 31300
        • Clinique Rive Gauche
        • Contact:
        • Principal Investigator:
          • Adelaïde DURAND, MD
    • Pays De La Loire
      • Saint-Nazaire, Pays De La Loire, France, 44600
        • Pediatric practice
        • Contact:
        • Principal Investigator:
          • Isabelle GUEMAS, MD
      • Trélazé, Pays De La Loire, France, 49800
        • Pediatric practice
        • Contact:
        • Principal Investigator:
          • Julie CHEIGNON, MD
    • Provence-Alpes-Côte d'Azur
      • Aix-en-Provence, Provence-Alpes-Côte d'Azur, France, 13090
        • Pediatric practice
        • Contact:
        • Principal Investigator:
          • Céline CASTAINGS-CARLIOZ, MD
      • Marseille, Provence-Alpes-Côte d'Azur, France, 13008
        • Pediatric practice
        • Contact:
          • Hélène Bellon, MD
          • Phone Number: 33 04 86 97 40 13
          • Email: h.bellon@sfr.fr
        • Principal Investigator:
          • Hélène Bellon, MD
      • Nice, Provence-Alpes-Côte d'Azur, France, 06000
        • Pediatric practice
        • Contact:
        • Principal Investigator:
          • Frédérique GASTAUD, MD
    • Provence-Alpes-Côte-d'Azur
      • Marseille, Provence-Alpes-Côte-d'Azur, France, 13012
        • Pediatric practice
        • Contact:
        • Principal Investigator:
          • Catherine BRUE FABRE, MD
    • Île-De-France
      • Paris, Île-De-France, France, 75010
        • Pediatric practice
        • Contact:
        • Principal Investigator:
          • Capucine VIGNON SAVOYE, MD
      • Paris, Île-De-France, France, 75011
        • Pediatric practice
        • Contact:
        • Principal Investigator:
          • Isabelle FLECHTNER, MD
      • Paris, Île-De-France, France, 75017
        • Pediatric practice
        • Contact:
        • Principal Investigator:
          • Maxime GERARD, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of recruited patients with at least 80% of the main data collected
Time Frame: Up to 48 month
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
Time Frame: Up to 48 month
Missing data rate less than 10% for pubertal stage.
Up to 48 month
At least 75% of patients included
Time Frame: Up to 48 month
At least 75% of patients included compared to the number of eligible patients.
Up to 48 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Emillie DOYE, MD, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Study Registration Dates

First Submitted

February 9, 2024

First Submitted That Met QC Criteria

February 9, 2024

First Posted (Actual)

February 16, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL23_1090
  • 2023-A02313-42 (Other Identifier: ID-RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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