Actively Recruiting

Phase Not Applicable
Age: 6Years - 8Years
FEMALE
ID06083415

Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context: Clinical and Biological Parameters, Endocrine Disruptor Exposure and Environmental Health Impact

Led by Lille Catholic University · Updated on 2026-03-17

62

Participants Needed

2

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying early breast development in girls aged 6 to 8 years, a phenomenon that has been increasing and is often without a clear medical cause. This trial aims to analyze many factors, including body fat, metabolism, exposure to endocrine disruptors, and epigenetic changes. The study also explores how environmental health measures might influence these factors and uses experimental models to test related biological hypotheses. The study involves two groups: girls aged 6 to 8 years with signs of breast development who are scheduled for pediatric day hospital care, and control girls of the same age without signs of puberty undergoing routine consultations or MRI scans for other reasons. Participants will have breast, ovary, uterus sizes, and abdominal fat measured by MRI at the start and after three months. Various biological and metabolic markers will be tested through blood, urine, and hair samples, and dental photographs will assess tooth mineralization. Participants will be followed over six months with measurements of growth, body mass index, and hormone levels at regular intervals. Assessments include MRI scans, bone age X-rays, and hormone tests at baseline, three months, and six months. The study monitors changes in breast development, fat distribution, and related biological markers to understand the impact of environmental factors and health measures on early puberty progression.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 6Years - 8Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Girls aged 6 to 8 years
  • Presenting breast development (isolated or not)
  • Scheduled for pediatric day hospital care
  • Agree to participate in the study
  • Parents agree to their child's participation
  • Participant and parents are French-speaking
  • Affiliated to social security
Not Eligible

You will not qualify if you...

  • History of neurocerebral disease such as malformations or developmental abnormalities
  • Organic causes of precocious puberty including Mac Cune Albright syndrome, ovarian cyst or tumor, adrenal hyperplasia
  • History of chemotherapy or radiation therapy
  • Communication disorders
  • Pregnancy
  • Under protective measures
  • Deprived of liberty for judicial or administrative reasons
  • Signs of puberty in controls (Tanner stages 2 to 5 breast development)
  • Previous chemotherapy or radiotherapy in controls
  • Communication disorder in controls
  • Pregnancy in controls
  • Protective supervision in controls
  • Deprivation of liberty in controls

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for eligibility assessment

Environmental Health Measures

Duration - 6 months

Participants undergo MRI scans, blood and urine tests, hair analysis, bone age X-rays, and dental photographs to assess breast development, biological parameters, endocrine disruptor exposure, and dental health.

Baseline visit and follow-up visits at 3 and 6 months

Trial Site Locations

Total: 2 locations

1

Cabinet BLM

Lambersart, Hauts-de-France, France, 59130

Actively Recruiting

2

Saint Vincent hospital

Lille, Hauts-de-France, France, 59000

Actively Recruiting

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Research Team

M

Marie-Paule LEBITASY

E

Elodie MOUTAILLER

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

2

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