Early Breast Development Study for Girls Aged 6 to 8
Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context
Recruiting
N/AInterventional Study
Puberty, PrecociousBreastEnvironmental Exposure
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
6 – 8
Sex
Female
Study type
Interventional
Purpose
Prevention
Participants needed
62 (estimated)
Sponsor
Lille Catholic University · Other
Who this trial is looking for
This trial is looking for girls aged 6 to 8 years who are experiencing breast development. Participants will undergo tests and provide information to help researchers understand early puberty and its causes.
Are You a Good Fit for This Trial?
You may be able to join if
I am a girl aged 6 to 8 years
I have breast development
I am coming for scheduled pediatric care
I agree to participate in the study
My parents agree to my participation
I can speak French
My parents can speak French
I am affiliated with social security
You may not be able to join if
I have a history of brain disease
I have a condition like Mac Cune Albright syndrome
I have had chemotherapy or radiation therapy
I have a communication disorder
I am pregnant
I am under protective measures
I am in custody for judicial reasons
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 o…
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.
Trial Locations
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Eligibility Criteria
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
* Who…
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
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