Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context

Environmental Exposure Clinical Trial

— PENELOPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06083415
• Other study ID #: RT-17
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2023
• Est. completion date: May 15, 2027

Study information

• Verified date: October 2023
• Source: Lille Catholic University
• Contact: Marie-Paule LEBITASY
• Phone: 03.20.22.52.69
• Email: lebitasy.marie-paule[@]ghicl.net
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 15, 2027
• Est. primary completion date: May 15, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 6 Years to 8 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast
• Environmental Exposure
• Puberty, Precocious

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Cabinet BLM	Lambersart	Nord Pas De Calais
France	Saint Vincent hospital	Lille	Nord Pas De Calais

Sponsors (1)

Lead Sponsor	Collaborator
Lille Catholic University

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline, 3 months
Primary	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	Baseline, 3 months,
Primary	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	Baseline, 3 months
Primary	Change from baseline of the weight	This parameter will allow to describe the clinical evolution of the weight after application of environmental health measures	Baseline, 3 months, 6 months
Primary	Change from baseline of the height	This parameter will allow to describe the clinical evolution of the height after application of environmental health measures	Baseline, 3 months, 6 months
Primary	Body mass index (BMI)	This parameter will allow to describe the clinical evolution of the BMI after application of environmental health measures	Baseline, 3 months, 6 months
Secondary	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.	Change from baseline at 90 days
Secondary	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	Change from baseline at 90 and 180 days
Secondary	Bone age determination by X ray	Determination of bone age to determine the maturity of the child's skeletal system.	Change from baseline at 90
Secondary	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	Baseline, 3 months
Secondary	Follicle-stimulating hormone (FSH) level	Blood test for determining the evolution of this parameter from baseline	Change from baseline at 90 days and 180 days
Secondary	Estradiol (E2) level	Blood test for determining the evolution of this parameter from baseline	Change from baseline at 90 days and 180 days
Secondary	Testosterone Level	Blood test for determining the evolution of this parameter from baseline	Change from baseline at 90 days and 180 days
Secondary	17 hydroxyprogesterone level	Blood test for determining the evolution of this parameter from baseline	Change from baseline at 90 days and 180 days
Secondary	Dehydroepiandrosterone sulfate level	Blood test for determining the evolution of this parameter from baseline	Change from baseline at 90 days and 180 days
Secondary	Sex Hormone-Binding Globulin level	Blood test for determining the evolution of this parameter from baseline	Change from baseline at 90 days and 180 days
Secondary	Thyroid Stimulating Hormone level	Blood test for determining the evolution of this parameter from baseline	Change from baseline at 90 days and 180 days
Secondary	FT4 (Free Thyroxine hormone) level	Blood test for determining the evolution of this parameter from baseline	Change from baseline at 90 days and 180 days
Secondary	Androstenedione level	Blood test for determining the evolution of this parameter from baseline	Change from baseline at 90 days and 180 days
Secondary	Insulin level	Blood test for determining the evolution of this parameter from baseline	Change from baseline at 90 days and 180 days
Secondary	Glycated hemoglobin (HbA1C) level	Blood test for determining the evolution of this parameter from baseline	Change from baseline at 90 days and 180 days
Secondary	Insulin-like Growth Factor-1 level	Blood test for determining the evolution of this parameter from baseline	Change from baseline at 90 days and 180 days
Secondary	Leptine level	Blood test for determining the evolution of this parameter from baseline	Change from baseline at 90 days and 180 days
Secondary	Luteinizing hormone (LH) level	Blood test for determining the evolution of this parameter from baseline	Change from baseline at 90 days and 180 days
Secondary	Glycemia level	Blood test for determining the evolution of this parameter from baseline	Change from baseline at 90 days and 180 days