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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 6
Maximum Age: 8
Healthy Volunteers: f
View:

• 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

• 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

Locations
Other Locations
France
Cabinet BLM
RECRUITING
Lambersart
Saint Vincent hospital
RECRUITING
Lille
Contact Information
Primary
Marie-Paule LEBITASY
lebitasy.marie-paule@ghicl.net
03.20.22.52.69
Backup
Elodie MOUTAILLER
moutailler.elodie@ghicl.net
03.20.22.52.69
Time Frame
Start Date: 2023-05-15
Estimated Completion Date: 2027-05-15
Participants
Target number of participants: 62
Treatments
Experimental: 6 to 8 years old girls, presenting with a breast flare-up
Girls aged 6 to 8 years old with breast flare (isolated or not) and scheduled for pediatric day hospital stay
No_intervention: 6 to 8 years old girls controls
Girls aged 6 to 8 years old controls, scheduled for pediatric day hospital stay, or an office consultation, or an MRI in radiology
Related Therapeutic Areas
Sponsors
Leads: Lille Catholic University

This content was sourced from clinicaltrials.gov