Investigating early breast growth in girls aged 6 to 8 years and its environmental influences
Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context: Clinical and Biological Parameters, Level of Impregnation With Endocrine Disruptors and Evaluation of the Impact of Environmental Health Measures
This study looks at why some girls aged 6 to 8 are developing breasts earlier than usual and what environmental factors might be causing it.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 62 (estimated) |
| Ages | 6 Years to 8 Years |
| Sex | Female |
| Sponsor | Lille Catholic University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 2 sites (Lambersart, Hauts-de-France and 1 other locations) |
| Trial ID | NCT06083415 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to analyze the phenomenon of early breast development in girls aged 6 to 8 years, focusing on potential environmental factors contributing to this condition. The study will assess various parameters, including adipose tissue, metabolism, endocrine disruptors, and epigenetic modifications. By examining these factors, the trial seeks to understand the impact of environmental health measures on the progression of early puberty. Additionally, data from participants will be explored in experimental models to test potential mechanisms behind these observations.
Who should consider this trial
Good fit: Ideal candidates for this study are French-speaking girls aged 6 to 8 years who are experiencing breast development.
Not a fit: Patients with organic causes of precocious puberty or those with a history of chemotherapy or radiation therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the environmental causes of early puberty, leading to better prevention and management strategies for affected girls.
How similar studies have performed: While there is limited data on similar studies, the investigation of environmental factors in early puberty is a growing area of interest, suggesting potential for novel insights.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Lambersart, Hauts-de-France and 1 other locations
- Cabinet BLM — Lambersart, Hauts-de-France, France (Recruiting)
- Saint Vincent hospital — Lille, Hauts-de-France, France (Recruiting)
Study contacts
- Principal investigator: Patricia RANNAUD-BARTAIRE, PhD — Hôpital Saint-Vincent de Paul
- Study coordinator: Marie-Paule LEBITASY
- Email: lebitasy.marie-paule@ghicl.net
- Phone: 03.20.22.52.69
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.