Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context (NCT06083415) | Clinical Trial Compass
RecruitingNot Applicable
Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context
France62 participantsStarted 2023-05-15
Plain-language 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.
Who can participate
Age range
6 Years – 8 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 dis…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from baseline of the size of the breast development measured by Magnetic Resonance Imaging
Timeframe: Baseline, 3 months
2
Change from baseline of the size of ovaries/uterus measured by Magnetic Resonance Imaging
Timeframe: Baseline, 3 months,
3
Change from baseline of the abdominal fat surface measured by Magnetic Resonance Imaging