Actively Recruiting
Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context
Led by Lille Catholic University · Updated on 2026-03-17
62
Participants Needed
2
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context
Who Can Participate
Eligibility Criteria
You may qualify if you...
For patients:
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Research Team
M
Marie-Paule LEBITASY
CONTACT
E
Elodie MOUTAILLER
CONTACT
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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