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

Lille Catholic University

Status: Enrolling

Conditions: Environmental Exposure; Breast; Puberty, Precocious

Treatments: Other: Environmental health measures

Study type: Interventional

Funder types: Other

Identifiers

NCT06083415

RT-17

Details and patient eligibility

About

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.

Enrollment: 62 estimated patients

Sex: Female

Ages: 6 to 8 years old

Volunteers: No Healthy Volunteers

Inclusion and 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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

6 to 8 years old girls, presenting with a breast flare-up

Experimental group

Description:

Girls aged 6 to 8 years old with breast flare (isolated or not) and scheduled for pediatric day hospital stay

Treatment:

Other: Environmental health measures

6 to 8 years old girls controls

No Intervention group

Description:

Girls aged 6 to 8 years old controls, scheduled for pediatric day hospital stay, or an office consultation, or an MRI in radiology