Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context
Launched by LILLE CATHOLIC UNIVERSITY · Oct 11, 2023
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
The PENELOPE clinical trial is studying why some girls aged 6 to 8 are experiencing early breast development, a condition known as precocious puberty. Researchers are looking into various factors that might be influencing this trend, particularly environmental elements like certain chemicals that can disrupt hormonal balance. By analyzing different aspects such as body fat, metabolism, and genetic changes, the study aims to gather a comprehensive understanding of what might be causing these early changes in puberty.
To participate in this study, girls must be between 6 and 8 years old and show signs of breast development. Their parents must also agree to their involvement and be able to communicate in French. During the trial, participants will undergo scheduled check-ups and tests to help researchers learn more about this important health issue. It's a chance to contribute to understanding why early puberty is happening more frequently, which could lead to better health guidelines for future generations.
Gender
FEMALE
Eligibility criteria
- 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
About Lille Catholic University
Lille Catholic University, a prominent academic institution in France, is dedicated to advancing healthcare through innovative research and clinical trials. With a strong emphasis on interdisciplinary collaboration, the university integrates expertise from various fields to foster the development of cutting-edge medical solutions. Its commitment to ethical standards and patient-centered approaches ensures that clinical trials conducted under its auspices are rigorous, scientifically sound, and aligned with the highest standards of care. By leveraging its extensive network of researchers, healthcare professionals, and resources, Lille Catholic University plays a vital role in contributing to the enhancement of medical knowledge and the improvement of patient outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Lille, Nord Pas De Calais, France
Lambersart, Nord Pas De Calais, France
Patients applied
Trial Officials
Patricia RANNAUD-BARTAIRE, PhD
Principal Investigator
Hôpital Saint-Vincent de Paul
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported