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

RecruitingNAAges 6 Years - 8 YearsFemaleLille Catholic University
NCT06083415 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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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What it tests

  • Environmental health measures
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Where

2 sites
Cabinet BLM
Lambersart, France
Saint Vincent hospital
Lille, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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