NCT06083415 Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context
| NCT ID | NCT06083415 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Lille Catholic University |
| Condition | Puberty, Precocious |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2023-05-15 |
| Primary Completion | 2026-05-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 62 participants in total. It began in 2023-05-15 with a primary completion date of 2026-05-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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 * 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
Contact & Investigator
Patricia RANNAUD-BARTAIRE, PhD
PRINCIPAL INVESTIGATOR
Hôpital Saint-Vincent de Paul
Frequently Asked Questions
Who can join the NCT06083415 clinical trial?
This trial is open to female participants only, aged 6 Years or older, up to 8 Years, studying Puberty, Precocious. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06083415 currently recruiting?
Yes, NCT06083415 is actively recruiting participants. Contact the research team at lebitasy.marie-paule@ghicl.net for enrollment information.
Where is the NCT06083415 trial being conducted?
This trial is being conducted at Lambersart, France, Lille, France.
Who is sponsoring the NCT06083415 clinical trial?
NCT06083415 is sponsored by Lille Catholic University. The principal investigator is Patricia RANNAUD-BARTAIRE, PhD at Hôpital Saint-Vincent de Paul. The trial plans to enroll 62 participants.