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NCT Number: NCT06083415

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

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.

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Key information

Conditions

Puberty, Precocious Breast Endocrine System Diseases Environmental Exposure Gonadal Disorders

Age range

6 year–8 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Cabinet BLM, Lambersart, Hauts-de-France, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Environmental health measures

Other

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.

Other names: Magnetic Resonance Imaging (MRI), Blood tests, Determination of endocrine disruptors in hair, Urine tests, Bone age x ray, Tooth photography (MIH)

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Secondary outcomes

  1. Measurement of endocrine disruptors in hair

    Time frame: Change from baseline at 90 days

    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.

  2. Tanner scale

    Time frame: Change from baseline at 90 and 180 days

    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

  3. Bone age determination by X ray

    Time frame: Change from baseline at 90

    Determination of bone age to determine the maturity of the child's skeletal system.

  4. Degree of severity of teeth hypomineralisation

    Time frame: Baseline, 3 months

    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

  5. Follicle-stimulating hormone (FSH) level

    Time frame: Change from baseline at 90 days and 180 days

    Blood test for determining the evolution of this parameter from baseline

  6. Estradiol (E2) level

    Time frame: Change from baseline at 90 days and 180 days

    Blood test for determining the evolution of this parameter from baseline

  7. Testosterone Level

    Time frame: Change from baseline at 90 days and 180 days

    Blood test for determining the evolution of this parameter from baseline

  8. 17 hydroxyprogesterone level

    Time frame: Change from baseline at 90 days and 180 days

    Blood test for determining the evolution of this parameter from baseline

  9. Dehydroepiandrosterone sulfate level

    Time frame: Change from baseline at 90 days and 180 days

    Blood test for determining the evolution of this parameter from baseline

  10. Sex Hormone-Binding Globulin level

    Time frame: Change from baseline at 90 days and 180 days

    Blood test for determining the evolution of this parameter from baseline

  11. Thyroid Stimulating Hormone level

    Time frame: Change from baseline at 90 days and 180 days

    Blood test for determining the evolution of this parameter from baseline

  12. FT4 (Free Thyroxine hormone) level

    Time frame: Change from baseline at 90 days and 180 days

    Blood test for determining the evolution of this parameter from baseline

  13. Androstenedione level

    Time frame: Change from baseline at 90 days and 180 days

    Blood test for determining the evolution of this parameter from baseline

  14. Insulin level

    Time frame: Change from baseline at 90 days and 180 days

    Blood test for determining the evolution of this parameter from baseline

  15. Glycated hemoglobin (HbA1C) level

    Time frame: Change from baseline at 90 days and 180 days

    Blood test for determining the evolution of this parameter from baseline

  16. Insulin-like Growth Factor-1 level

    Time frame: Change from baseline at 90 days and 180 days

    Blood test for determining the evolution of this parameter from baseline

  17. Leptine level

    Time frame: Change from baseline at 90 days and 180 days

    Blood test for determining the evolution of this parameter from baseline

  18. Luteinizing hormone (LH) level

    Time frame: Change from baseline at 90 days and 180 days

    Blood test for determining the evolution of this parameter from baseline

  19. Glycemia level

    Time frame: Change from baseline at 90 days and 180 days

    Blood test for determining the evolution of this parameter from baseline

Study contacts

Contact information is provided by the study sponsor or research team.

Elodie MOUTAILLER

CONTACT

[email protected]

03.20.22.52.69 ext. +33

Marie-Paule LEBITASY

CONTACT

[email protected]

03.20.22.52.69 ext. +33

Sponsors and collaborators

Lead sponsor

Lille Catholic University

Other

Registry information

Official study 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

Acronym: PENELOPE

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Oct 16, 2023
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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