Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context
Condition(s) studied
Investigational drug(s) / intervention(s)
Environmental health measures: MRI will be used to confirm the presence of breast buds, to measure the size of the ovaries and uterus, as well as the fraction of fat mass (abdominal, subcutaneous, liver and bone marrow). The bood and urine tests will allow to measure different biological and metabolic parameters. The presence of endocrine disruptors will be determined in the hair. The bone age x ray will be estimate the maturity of the child's skeletal system. Photographs of the teeth will also be taken to be studied by pediatric odontology researchers on the on molar and incisor hypomineralization, known as MIH.
Study summary
Various studies show an increase in the number of cases of early puberty in girls with breast development with a variable clinical presentation and evolution. This increasing phenomenon concerns girls between 6 and 8 years old. In a large number of cases, from 70 to 95% depending on the series, no medical cause is found and environmental factors are suspected to be involved.
Descriptive studies of these patients are scarce and not always provide an overview of all the parameters in line with the concept of the exposome.
The PENELOPE clinical trial will allow to analyze a large number of parameters, including the adipose tissue, its metabolism, the endocrine disruptors, and the epigenetic modifications, and to study the impact of environmental health measures in the evolution of these parameters.
The data from the analyses of the endocrine disruptors of the patients will be explored in parallel in experimental models (amphibians, murine, cellular) in order to test potential mechanistic hypotheses.
Eligibility
Primary outcome measure(s)
- Change from baseline of the size of the breast development measured by Magnetic Resonance Imaging — Baseline, 3 months
This parameter will allow to describe the clinical evolution of breast development after application of environmental health measures - Change from baseline of the size of ovaries/uterus measured by Magnetic Resonance Imaging — Baseline, 3 months,
This parameter will allow to describe the clinical evolution of ovaries and uterus after application of environmental health measures - Change from baseline of the abdominal fat surface measured by Magnetic Resonance Imaging — Baseline, 3 months
This parameter will allow to describe the clinical evolution of the abdominal fat surface after application of environmental health measures - Change from baseline of the weight — Baseline, 3 months, 6 months
This parameter will allow to describe the clinical evolution of the weight after application of environmental health measures - Change from baseline of the height — Baseline, 3 months, 6 months
This parameter will allow to describe the clinical evolution of the height after application of environmental health measures - Body mass index (BMI) — Baseline, 3 months, 6 months
This parameter will allow to describe the clinical evolution of the BMI after application of environmental health measures
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Cabinet BLM | Lambersart | Hauts-de-France | Recruiting |
| Saint Vincent hospital | Lille | Hauts-de-France | Recruiting |
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06083415 on ClinicalTrials.gov ↗ ← All trials in France