An interventional study of Environmental health measures in Puberty, Precocious, Breast and Environmental Exposure, sponsored by Lille Catholic University. Recruiting at 2 sites in France. Open to female participants aged 6 Years to 8 Years. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by Lille Catholic University · Not applicable, Interventional, and Prevention
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.
75 studies on the registry are indexed under Puberty, Precocious; 18 are open to participants now.
This study's planned enrollment of 62 is close to the median of 64 across 47 interventional studies indexed under Puberty, Precocious.
Browse Puberty, Precocious studies →Lille Catholic University is the lead sponsor of 112 studies on the registry; 24 are open to participants now.
Counted across the registry records on this site, refreshed daily.
For patients:
Inclusion Criteria:
Exclusion Criteria:
For controls:
Inclusion Criteria:
Exclusion Criteria:
Girls aged 6 to 8 years old with breast flare (isolated or not) and scheduled for pediatric day hospital stay
Other: Environmental health measures
Girls aged 6 to 8 years old controls, scheduled for pediatric day hospital stay, or an office consultation, or an MRI in radiology
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.
Also known as: Magnetic Resonance Imaging (MRI), Blood tests, Determination of endocrine disruptors in hair, Urine tests, Bone age x ray, Tooth photography (MIH)
Change from baseline of the size of the breast development measured by Magnetic Resonance Imaging
This parameter will allow to describe the clinical evolution of breast development after application of environmental health measures
Time frame: Baseline, 3 months
Change from baseline of the size of ovaries/uterus measured by Magnetic Resonance Imaging
This parameter will allow to describe the clinical evolution of ovaries and uterus after application of environmental health measures
Time frame: Baseline, 3 months,
Change from baseline of the abdominal fat surface measured by Magnetic Resonance Imaging
This parameter will allow to describe the clinical evolution of the abdominal fat surface after application of environmental health measures
Time frame: Baseline, 3 months
Change from baseline of the weight
This parameter will allow to describe the clinical evolution of the weight after application of environmental health measures
Time frame: Baseline, 3 months, 6 months
Change from baseline of the height
This parameter will allow to describe the clinical evolution of the height after application of environmental health measures
Time frame: Baseline, 3 months, 6 months
Body mass index (BMI)
This parameter will allow to describe the clinical evolution of the BMI after application of environmental health measures
Time frame: Baseline, 3 months, 6 months
Measurement of endocrine disruptors in hair
Describe the evolution of the amount of endocrine disruptors in hair after the implementation of environmental health measures. from 70 to 100 mg of hair will cut as close as possible to the scalp at the posterior vertex, and stored at room temperature to measure endocrine disruptors such as parabens, phthalates, bisphenols and pesticides.
Time frame: Change from baseline at 90 days
Tanner scale
The Tanner scale is a scale of physical development as children transition into adolescence and then adulthood. The scale defines physical measurements of development based on external primary and secondary sex characteristics. Breast: Tanner I: no glandular tissue Tanner II: breast bud forms, areola begins to widen Tanner III: breast begins to become more elevated, and extends beyond the borders of the areola, Tanner IV: increased breast sizing and elevation; areola and papilla form a secondary mound projecting from the contour of the surrounding breast Tanner V: breast reaches final adult size Pubis hair: Tanner I: no pubic hair Tanner II: small amount of long, downy hair Tanner III: hair becomes more coarse and curly, and begins to extend laterally Tanner IV: adult-like hair quality, extending across pubis but sparing medial thighs Tanner V: hair extends to medial surface of the thighs
Time frame: Change from baseline at 90 and 180 days
Bone age determination by X ray
Determination of bone age to determine the maturity of the child's skeletal system.
Time frame: Change from baseline at 90
Degree of severity of teeth hypomineralisation
The dree of severity is determine according to a scale: 1: \<30% of the tooth's enamel surface area visibly disrupted, 2: 31 to 49% of the tooth's enamel surface area visibly disrupted, 3: \>50% of the tooth's enamel surface area visibly disrupted
Time frame: Baseline, 3 months
Follicle-stimulating hormone (FSH) level
Blood test for determining the evolution of this parameter from baseline
Time frame: Change from baseline at 90 days and 180 days
Estradiol (E2) level
Blood test for determining the evolution of this parameter from baseline
Time frame: Change from baseline at 90 days and 180 days
Testosterone Level
Blood test for determining the evolution of this parameter from baseline
Time frame: Change from baseline at 90 days and 180 days
17 hydroxyprogesterone level
Blood test for determining the evolution of this parameter from baseline
Time frame: Change from baseline at 90 days and 180 days
Dehydroepiandrosterone sulfate level
Blood test for determining the evolution of this parameter from baseline
Time frame: Change from baseline at 90 days and 180 days
Sex Hormone-Binding Globulin level
Blood test for determining the evolution of this parameter from baseline
Time frame: Change from baseline at 90 days and 180 days
Thyroid Stimulating Hormone level
Blood test for determining the evolution of this parameter from baseline
Time frame: Change from baseline at 90 days and 180 days
FT4 (Free Thyroxine hormone) level
Blood test for determining the evolution of this parameter from baseline
Time frame: Change from baseline at 90 days and 180 days
Androstenedione level
Blood test for determining the evolution of this parameter from baseline
Time frame: Change from baseline at 90 days and 180 days
Insulin level
Blood test for determining the evolution of this parameter from baseline
Time frame: Change from baseline at 90 days and 180 days
Glycated hemoglobin (HbA1C) level
Blood test for determining the evolution of this parameter from baseline
Time frame: Change from baseline at 90 days and 180 days
Insulin-like Growth Factor-1 level
Blood test for determining the evolution of this parameter from baseline
Time frame: Change from baseline at 90 days and 180 days
Leptine level
Blood test for determining the evolution of this parameter from baseline
Time frame: Change from baseline at 90 days and 180 days
Luteinizing hormone (LH) level
Blood test for determining the evolution of this parameter from baseline
Time frame: Change from baseline at 90 days and 180 days
Glycemia level
Blood test for determining the evolution of this parameter from baseline
Time frame: Change from baseline at 90 days and 180 days
Plan to share: No
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