Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age6-8
SponsorLille Catholic University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Environmental health measures
Other interventionMRI 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.
Treatment groups
62 Participants
are divided into 2 treatment groupsGroup A: 6 to 8 years old girls, presenting with a breast flare-upExperimental treatment 1 intervention
Group B: 6 to 8 years old girls controlsNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 months2
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,3
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 months4
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 monthsSecondary outcomes
1
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 days2
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 days3
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 904
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 monthsSponsors and contacts
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Source ClinicalTrials.gov