Clinical trial NCT06083415: Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Puberty, Precocious
Breast
Environmental Exposure
Keywords: Early puberty
Endocrine disruptors
Girls
Breast growth
Environmental Health Measure
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 50
Sex: FEMALE
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline of the size of the breast development measured by Magnetic Resonance Imaging
timeFrame: Baseline, 3 months
measure: Change from baseline of the size of ovaries/uterus measured by Magnetic Resonance Imaging
timeFrame: Baseline, 3 months,
measure: Change from baseline of the abdominal fat surface measured by Magnetic Resonance Imaging
timeFrame: Baseline, 3 months
measure: Change from baseline of the weight
timeFrame: Baseline, 3 months, 6 months
measure: Change from baseline of the height
timeFrame: Baseline, 3 months, 6 months
measure: Body mass index (BMI)
timeFrame: Baseline, 3 months, 6 months
Secondary outcomes:
measure: Measurement of endocrine disruptors in hair
timeFrame: Change from baseline at 90 days
measure: Tanner scale
timeFrame: Change from baseline at 90 and 180 days
measure: Bone age determination by X ray
timeFrame: Change from baseline at 90
measure: Degree of severity of teeth hypomineralisation
timeFrame: Baseline, 3 months
measure: Follicle-stimulating hormone (FSH) level
timeFrame: Change from baseline at 90 days and 180 days
measure: Estradiol (E2) level
timeFrame: Change from baseline at 90 days and 180 days
measure: Testosterone Level
timeFrame: Change from baseline at 90 days and 180 days
measure: 17 hydroxyprogesterone level
timeFrame: Change from baseline at 90 days and 180 days
measure: Dehydroepiandrosterone sulfate level
timeFrame: Change from baseline at 90 days and 180 days
measure: Sex Hormone-Binding Globulin level
timeFrame: Change from baseline at 90 days and 180 days
measure: Thyroid Stimulating Hormone level
timeFrame: Change from baseline at 90 days and 180 days
measure: FT4 (Free Thyroxine hormone) level
timeFrame: Change from baseline at 90 days and 180 days
measure: Androstenedione level
timeFrame: Change from baseline at 90 days and 180 days
measure: Insulin level
timeFrame: Change from baseline at 90 days and 180 days
measure: Glycated hemoglobin (HbA1C) level
timeFrame: Change from baseline at 90 days and 180 days
measure: Insulin-like Growth Factor-1 level
timeFrame: Change from baseline at 90 days and 180 days
measure: Leptine level
timeFrame: Change from baseline at 90 days and 180 days
measure: Luteinizing hormone (LH) level
timeFrame: Change from baseline at 90 days and 180 days
measure: Glycemia level
timeFrame: Change from baseline at 90 days and 180 days
Other outcomes:
Locations:
city: Lambersart
country: France
facility: Cabinet BLM
state: Nord Pas De Calais
city: Lille
country: France
facility: Saint Vincent hospital
state: Nord Pas De Calais
Study officials:
affiliation: Hôpital Saint-Vincent de Paul
name: Patricia RANNAUD-BARTAIRE, PhD
role: PRINCIPAL_INVESTIGATOR
References: