Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context: Clinical and Biological Parameters, Level of Impregnation With Endocrine Disruptors and Evaluation of the Impact of Environmental Health Measures
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 62
- Locations
- 4
- Primary Endpoint
- Change from baseline of the height
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to 8 Years (Child)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •For patients:
- •Inclusion Criteria:
- •Girls aged 6 to 8 years
- •Presenting a breast development (isolated or not)
- •Undergoing scheduled pediatric day hospital care (HDJ)
- •Who agree to participate in the study
- •Whose parents agree to their child's participation in the study
- •French speaking
- •Whose parents speak French
- •Affiliated to social security
Exclusion Criteria
- •Organic brain causes of precocious puberty: History of neurocerebral disease (malformations, developmental abnormalities)
- •Organic causes of precocious puberty: Mac Cune Albright syndrome, ovarian cyst or tumor and adrenal hyperplasia
- •History of chemotherapy or radiation therapy
- •Presenting with a communication disorder
- •Pregnancy
- •Persons under protective measures
- •Persons deprived of liberty for judicial or administrative reasons
- •For controls:
- •Inclusion Criteria:
- •Girls aged 6 to 8
- •Tanner stage 1: Absence of breasts and hairiness
- •Coming for routine consultation in the pediatric HDJ at Saint-Vincent-de-Paul hospital, or at the BLM practice in Lambersart, or to radiology for an MRI for another medical other medical reason
- •Agree to participate in the study
- •Whose parents agree to their child's participation in the the study
- •French-speaking
- •Whose parents speak French
- •Affiliated with social security
- •Exclusion Criteria:
- •Signs of puberty (Tanner stages 2, 3, 4 and 5 for breast development) breast development)
- •Previous chemotherapy or radiotherapy
- •Presenting a communication disorder
- •Pregnant women
- •Persons under protective supervision
- •Persons deprived of their liberty for judicial or administrative reasons
Arms & Interventions
6 to 8 years old girls, presenting with a breast flare-up
Girls aged 6 to 8 years old with breast flare (isolated or not) and scheduled for pediatric day hospital stay
Intervention: Environmental health measures (Other)
6 to 8 years old girls controls
Girls aged 6 to 8 years old controls, scheduled for pediatric day hospital stay, or an office consultation, or an MRI in radiology
Outcomes
Primary Outcomes
Change from baseline of the height
Time Frame: Baseline, 3 months, 6 months
This parameter will allow to describe the clinical evolution of the height after application of environmental health measures
Change from baseline of the size of the breast development measured by Magnetic Resonance Imaging
Time Frame: 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
Time Frame: Baseline, 3 months,
This parameter will allow to describe the clinical evolution of ovaries and uterus after application of environmental health measures
Body mass index (BMI)
Time Frame: Baseline, 3 months, 6 months
This parameter will allow to describe the clinical evolution of the BMI after application of environmental health measures
Change from baseline of the abdominal fat surface measured by Magnetic Resonance Imaging
Time Frame: 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
Time Frame: Baseline, 3 months, 6 months
This parameter will allow to describe the clinical evolution of the weight after application of environmental health measures
Secondary Outcomes
- Thyroid Stimulating Hormone level(Change from baseline at 90 days and 180 days)
- FT4 (Free Thyroxine hormone) level(Change from baseline at 90 days and 180 days)
- Degree of severity of teeth hypomineralisation(Baseline, 3 months)
- 17 hydroxyprogesterone level(Change from baseline at 90 days and 180 days)
- Sex Hormone-Binding Globulin level(Change from baseline at 90 days and 180 days)
- Bone age determination by X ray(Change from baseline at 90)
- Tanner scale(Change from baseline at 90 and 180 days)
- Estradiol (E2) level(Change from baseline at 90 days and 180 days)
- Measurement of endocrine disruptors in hair(Change from baseline at 90 days)
- Glycated hemoglobin (HbA1C) level(Change from baseline at 90 days and 180 days)
- Glycemia level(Change from baseline at 90 days and 180 days)
- Insulin-like Growth Factor-1 level(Change from baseline at 90 days and 180 days)
- Follicle-stimulating hormone (FSH) level(Change from baseline at 90 days and 180 days)
- Testosterone Level(Change from baseline at 90 days and 180 days)
- Dehydroepiandrosterone sulfate level(Change from baseline at 90 days and 180 days)
- Androstenedione level(Change from baseline at 90 days and 180 days)
- Leptine level(Change from baseline at 90 days and 180 days)
- Luteinizing hormone (LH) level(Change from baseline at 90 days and 180 days)
- Insulin level(Change from baseline at 90 days and 180 days)