Puberty, PrecociousPAPPELNCT06263868
First Observatory of Precocious Puberty.
An observational study of Puberty, Precocious, run by Hospices Civils de Lyon at 23 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Puberty, Precocious
- How many people
- 3,360 participants
- Where
- 23 sitesFrance
- Study dates
- 26 Jun 2024to 26 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 11 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Who may be able to join
- 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).
Show all 10Show fewer
- 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
Who cannot join
- 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 locations and contacts
23 sites in 1 country.
23 sites in 1 country
France23 sites
Pediatric practice
Aix-en-Provence, 13090
Hôpital Femme Mère Enfant, Hospices civils de Lyon
Bron, 69677
Pediatric practice
Chambray-lès-Tours, Centre-Val de Loire, 37170
Clinique du Val d'Ouest
Écully, Auvergne-Rhône-Alpes, 69130
Pediatric practice
Essey-lès-Nancy, Grand Est, 54270
Pediatric practice
Fondettes, Indre-et-Loire, 37230
Pediatric practice
Levallois-Perret, Hauts-de-Seine, 92300
Polyclinique Bordeaux rive droite
Lormont, New Aquitaine, 33310
Pediatric practice
Lyon, Auvergne-Rhône-Alpes, 69006
Pediatric practice
Marseille, 13008
Pediatric practice
Marseille, 13012
Pediatric practice
Nice, 06000
Pediatric practice
Paris, Île-de-France Region, 75010
Pediatric practice
Paris, Île-de-France Region, 75011
Pediatric practice
Paris, Île-de-France Region, 75017
Pediatric practice
Paris, Île-de-France Region, 75116
Pediatric practice
Pau, New Aquitaine, 64000
Pediatric Practice
Pessac, New Aquitaine, 33600
Pediatric practice
Rennes, Brittany Region, 35200
Clinique Saint jean
Saint-Jean-de-Védas, 34430
Pediatric practice
Saint-Nazaire, Pays de la Loire Region, 44600
Clinique rive gauche
Toulouse, Occitanie, 31300
Pediatric practice
Trélazé, 49800
About this study
Official 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.
Read more
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.
- Conditions
- Puberty, Precocious
- Keywords
- Early/precocious puberty, advanced puberty, national observatory, private medicine, feasibility
- Medical subject headings
- Puberty, Precocious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 48 month
Missing data rate
Missing data rate less than 10% for pubertal stage.
Measured: Up to 48 month
At least 75% of patients included
At least 75% of patients included compared to the number of eligible patients.
Measured: Up to 48 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start26 Jun 2024
- Primary completion26 Jun 2028 (estimated)
- Study completion26 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Puberty, PrecociousStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3,360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emillie DOYE, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06263868
- Sponsor's protocol ID
- 69HCL23_1090
- Other IDs
- 2023-A02313-42
- Acronym
- PAPPEL
- Status last verified
- Jan 2026
- First submitted
- 9 Feb 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- First Observatory of Precocious and Advanced Puberty in Private Healthcare.
- ClinicalTrials.gov ID
- NCT06263868
- Acronym / sponsor ID
- PAPPEL / 69HCL23_1090
- Conditions
- Puberty, Precocious
- Keywords
- Early/precocious puberty, advanced puberty, national observatory, private medicine, feasibility
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,360 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 26 Jun 2028 (estimated)
- Study completion
- 26 Jun 2028 (estimated)
- First posted
- 16 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- Up to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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.
Key inclusion criteria (10 listed)
- 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).
- Boy or girl without signs of pubertal development (Tanner 1);
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Missing data rate
Time frame: Up to 48 month
Missing data rate less than 10% for pubertal stage.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emillie DOYE, MD principal investigator
Hospices Civils de Lyon
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Puberty, Precocious, run by Hospices Civils de Lyon at 23 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of recruited patients with at least 80% of the main data collected (time frame: Up to 48 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.