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

NCT06083415 | Recruiting

• 1 other identifier: RT-17
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 2

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.

Conditions

Environmental Exposure; Puberty, Precocious; Breast

Keywords

Early puberty; Endocrine disruptors; Girls; Breast growth; Environmental Health Measure

Outcome Measures

Primary Outcomes (6)

• 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

• 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,

• 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

• 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

• 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

• 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 Outcomes (19)

• Measurement of endocrine disruptors in hair

  Change from baseline at 90 days

• Tanner scale

  Change from baseline at 90 and 180 days

• Bone age determination by X ray

  Change from baseline at 90

• Degree of severity of teeth hypomineralisation

  Baseline, 3 months

• Follicle-stimulating hormone (FSH) level

  Change from baseline at 90 days and 180 days

Study Arms (2)

6 to 8 years old girls, presenting with a breast flare-up

EXPERIMENTAL

Girls aged 6 to 8 years old with breast flare (isolated or not) and scheduled for pediatric day hospital stay

Other: Environmental health measures

6 to 8 years old girls controls

NO INTERVENTION

Girls aged 6 to 8 years old controls, scheduled for pediatric day hospital stay, or an office consultation, or an MRI in radiology

Interventions

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.

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

6 to 8 years old girls, presenting with a breast flare-up

Eligibility Criteria

• Age: 6 Years - 8 Years
• Gender Eligibility Details: Girls aged 6 to 8 years presenting a breast development (isolated or not) or not (controls)
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• Lille Catholic University: lead

Study Sites (2)

Cabinet BLM

Lambersart, Hauts-de-France, 59130, France

RECRUITING

Saint Vincent hospital

Lille, Hauts-de-France, 59000, France

RECRUITING

MeSH Terms

Conditions

Puberty, Precocious

Interventions

Magnetic Resonance Spectroscopy; Hematologic Tests; Urinalysis

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Clinical Chemistry Tests; Diagnostic Techniques, Urological

Study Officials

• Patricia RANNAUD-BARTAIRE, PhD

  Hôpital Saint-Vincent de Paul

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Paule LEBITASY

CONTACT

03.20.22.52.69; lebitasy.marie-paule@ghicl.net

Elodie MOUTAILLER

CONTACT

03.20.22.52.69; moutailler.elodie@ghicl.net

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 4, 2023
• First Posted: October 16, 2023
• Study Start: May 15, 2023
• Primary Completion (Estimated): May 15, 2026
• Study Completion (Estimated): May 15, 2027
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)