NCT06083415

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 62 (estimated)
• Sponsor: Lille Catholic University · Academic / Other
• Sex: Female
• Age: 6 Years – 8 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Puberty, Precocious
• Breast
• Environmental Exposure

Interventions

Type	Name	Description
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. 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.

Timeline

• Start date: 2023-05-15
• Primary completion: 2026-05-15
• Completion: 2027-05-15
• First posted: 2023-10-16
• Last updated: 2026-03-17

Locations

2 sites across 1 country: France