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New treatment option for Puberty, Precocious
Official title Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context
ClinicalTrials.gov ID: NCT06083415
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 8, women only
You may be able to join if
- For patients:
- 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
You likely can't join if
- 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
See the full eligibility criteria
- For patients:
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Lambersart, Hauts-de-France, France
- Lille, Hauts-de-France, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 6 years to 8 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Lambersart, Hauts-de-France, France; Lille, Hauts-de-France, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.