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

Primary Purpose

Puberty, Precocious, Breast, Environmental Exposure

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Environmental health measures
Sponsored by
Lille Catholic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Puberty, Precocious focused on measuring Early puberty, Endocrine disruptors, Girls, Breast growth, Environmental Health Measure

Eligibility Criteria

6 Years - 8 Years (Child)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Cabinet BLMRecruiting
  • Saint Vincent hospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

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

Outcomes

Primary Outcome Measures

Change from baseline of the size of the breast development measured by Magnetic Resonance Imaging
This parameter will allow to describe the clinical evolution of breast development after application of environmental health measures
Change from baseline of the size of ovaries/uterus measured by Magnetic Resonance Imaging
This parameter will allow to describe the clinical evolution of ovaries and uterus after application of environmental health measures
Change from baseline of the abdominal fat surface measured by Magnetic Resonance Imaging
This parameter will allow to describe the clinical evolution of the abdominal fat surface after application of environmental health measures
Change from baseline of the weight
This parameter will allow to describe the clinical evolution of the weight after application of environmental health measures
Change from baseline of the height
This parameter will allow to describe the clinical evolution of the height after application of environmental health measures
Body mass index (BMI)
This parameter will allow to describe the clinical evolution of the BMI after application of environmental health measures

Secondary Outcome Measures

Measurement of endocrine disruptors in hair
Describe the evolution of the amount of endocrine disruptors in hair after the implementation of environmental health measures. from 70 to 100 mg of hair will cut as close as possible to the scalp at the posterior vertex, and stored at room temperature to measure endocrine disruptors such as parabens, phthalates, bisphenols and pesticides.
Tanner scale
The Tanner scale is a scale of physical development as children transition into adolescence and then adulthood. The scale defines physical measurements of development based on external primary and secondary sex characteristics. Breast: Tanner I: no glandular tissue Tanner II: breast bud forms, areola begins to widen Tanner III: breast begins to become more elevated, and extends beyond the borders of the areola, Tanner IV: increased breast sizing and elevation; areola and papilla form a secondary mound projecting from the contour of the surrounding breast Tanner V: breast reaches final adult size Pubis hair: Tanner I: no pubic hair Tanner II: small amount of long, downy hair Tanner III: hair becomes more coarse and curly, and begins to extend laterally Tanner IV: adult-like hair quality, extending across pubis but sparing medial thighs Tanner V: hair extends to medial surface of the thighs
Bone age determination by X ray
Determination of bone age to determine the maturity of the child's skeletal system.
Degree of severity of teeth hypomineralisation
The dree of severity is determine according to a scale: 1: <30% of the tooth's enamel surface area visibly disrupted, 2: 31 to 49% of the tooth's enamel surface area visibly disrupted, 3: >50% of the tooth's enamel surface area visibly disrupted
Follicle-stimulating hormone (FSH) level
Blood test for determining the evolution of this parameter from baseline
Estradiol (E2) level
Blood test for determining the evolution of this parameter from baseline
Testosterone Level
Blood test for determining the evolution of this parameter from baseline
17 hydroxyprogesterone level
Blood test for determining the evolution of this parameter from baseline
Dehydroepiandrosterone sulfate level
Blood test for determining the evolution of this parameter from baseline
Sex Hormone-Binding Globulin level
Blood test for determining the evolution of this parameter from baseline
Thyroid Stimulating Hormone level
Blood test for determining the evolution of this parameter from baseline
FT4 (Free Thyroxine hormone) level
Blood test for determining the evolution of this parameter from baseline
Androstenedione level
Blood test for determining the evolution of this parameter from baseline
Insulin level
Blood test for determining the evolution of this parameter from baseline
Glycated hemoglobin (HbA1C) level
Blood test for determining the evolution of this parameter from baseline
Insulin-like Growth Factor-1 level
Blood test for determining the evolution of this parameter from baseline
Leptine level
Blood test for determining the evolution of this parameter from baseline
Luteinizing hormone (LH) level
Blood test for determining the evolution of this parameter from baseline
Glycemia level
Blood test for determining the evolution of this parameter from baseline

Full Information

First Posted
October 4, 2023
Last Updated
October 11, 2023
Sponsor
Lille Catholic University
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1. Study Identification

Unique Protocol Identification Number
NCT06083415
Brief Title
Early Breast Growth in Girls Aged 6 to 8 Years in the Current Environmental Context
Acronym
PENELOPE
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
May 15, 2026 (Anticipated)
Study Completion Date
May 15, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lille Catholic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Puberty, Precocious, Breast, Environmental Exposure
Keywords
Early puberty, Endocrine disruptors, Girls, Breast growth, Environmental Health Measure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
6 to 8 years old girls, presenting with a breast flare-up
Arm Type
Experimental
Arm Description
Girls aged 6 to 8 years old with breast flare (isolated or not) and scheduled for pediatric day hospital stay
Intervention Type
Other
Intervention Name(s)
Environmental health measures
Other Intervention Name(s)
Magnetic Resonance Imaging (MRI), Blood tests, Determination of endocrine disruptors in hair, Urine tests, Bone age x ray
Intervention Description
MRI will be used to confirm the presence of breast buds, to measure the size of the ovaries and uterus, as well as the fraction of fat mass (abdominal, subcutaneous, liver and bone marrow). The bood and urine tests will allow to measure different biological and metabolic parameters. The presence of endocrine disruptors will be determined in the hair. The bone age x ray will be estimate the maturity of the child's skeletal system.
Primary Outcome Measure Information:
Title
Change from baseline of the size of the breast development measured by Magnetic Resonance Imaging
Description
This parameter will allow to describe the clinical evolution of breast development after application of environmental health measures
Time Frame
Baseline, 3 months
Title
Change from baseline of the size of ovaries/uterus measured by Magnetic Resonance Imaging
Description
This parameter will allow to describe the clinical evolution of ovaries and uterus after application of environmental health measures
Time Frame
Baseline, 3 months,
Title
Change from baseline of the abdominal fat surface measured by Magnetic Resonance Imaging
Description
This parameter will allow to describe the clinical evolution of the abdominal fat surface after application of environmental health measures
Time Frame
Baseline, 3 months
Title
Change from baseline of the weight
Description
This parameter will allow to describe the clinical evolution of the weight after application of environmental health measures
Time Frame
Baseline, 3 months, 6 months
Title
Change from baseline of the height
Description
This parameter will allow to describe the clinical evolution of the height after application of environmental health measures
Time Frame
Baseline, 3 months, 6 months
Title
Body mass index (BMI)
Description
This parameter will allow to describe the clinical evolution of the BMI after application of environmental health measures
Time Frame
Baseline, 3 months, 6 months
Secondary Outcome Measure Information:
Title
Measurement of endocrine disruptors in hair
Description
Describe the evolution of the amount of endocrine disruptors in hair after the implementation of environmental health measures. from 70 to 100 mg of hair will cut as close as possible to the scalp at the posterior vertex, and stored at room temperature to measure endocrine disruptors such as parabens, phthalates, bisphenols and pesticides.
Time Frame
Change from baseline at 90 days
Title
Tanner scale
Description
The Tanner scale is a scale of physical development as children transition into adolescence and then adulthood. The scale defines physical measurements of development based on external primary and secondary sex characteristics. Breast: Tanner I: no glandular tissue Tanner II: breast bud forms, areola begins to widen Tanner III: breast begins to become more elevated, and extends beyond the borders of the areola, Tanner IV: increased breast sizing and elevation; areola and papilla form a secondary mound projecting from the contour of the surrounding breast Tanner V: breast reaches final adult size Pubis hair: Tanner I: no pubic hair Tanner II: small amount of long, downy hair Tanner III: hair becomes more coarse and curly, and begins to extend laterally Tanner IV: adult-like hair quality, extending across pubis but sparing medial thighs Tanner V: hair extends to medial surface of the thighs
Time Frame
Change from baseline at 90 and 180 days
Title
Bone age determination by X ray
Description
Determination of bone age to determine the maturity of the child's skeletal system.
Time Frame
Change from baseline at 90
Title
Degree of severity of teeth hypomineralisation
Description
The dree of severity is determine according to a scale: 1: <30% of the tooth's enamel surface area visibly disrupted, 2: 31 to 49% of the tooth's enamel surface area visibly disrupted, 3: >50% of the tooth's enamel surface area visibly disrupted
Time Frame
Baseline, 3 months
Title
Follicle-stimulating hormone (FSH) level
Description
Blood test for determining the evolution of this parameter from baseline
Time Frame
Change from baseline at 90 days and 180 days
Title
Estradiol (E2) level
Description
Blood test for determining the evolution of this parameter from baseline
Time Frame
Change from baseline at 90 days and 180 days
Title
Testosterone Level
Description
Blood test for determining the evolution of this parameter from baseline
Time Frame
Change from baseline at 90 days and 180 days
Title
17 hydroxyprogesterone level
Description
Blood test for determining the evolution of this parameter from baseline
Time Frame
Change from baseline at 90 days and 180 days
Title
Dehydroepiandrosterone sulfate level
Description
Blood test for determining the evolution of this parameter from baseline
Time Frame
Change from baseline at 90 days and 180 days
Title
Sex Hormone-Binding Globulin level
Description
Blood test for determining the evolution of this parameter from baseline
Time Frame
Change from baseline at 90 days and 180 days
Title
Thyroid Stimulating Hormone level
Description
Blood test for determining the evolution of this parameter from baseline
Time Frame
Change from baseline at 90 days and 180 days
Title
FT4 (Free Thyroxine hormone) level
Description
Blood test for determining the evolution of this parameter from baseline
Time Frame
Change from baseline at 90 days and 180 days
Title
Androstenedione level
Description
Blood test for determining the evolution of this parameter from baseline
Time Frame
Change from baseline at 90 days and 180 days
Title
Insulin level
Description
Blood test for determining the evolution of this parameter from baseline
Time Frame
Change from baseline at 90 days and 180 days
Title
Glycated hemoglobin (HbA1C) level
Description
Blood test for determining the evolution of this parameter from baseline
Time Frame
Change from baseline at 90 days and 180 days
Title
Insulin-like Growth Factor-1 level
Description
Blood test for determining the evolution of this parameter from baseline
Time Frame
Change from baseline at 90 days and 180 days
Title
Leptine level
Description
Blood test for determining the evolution of this parameter from baseline
Time Frame
Change from baseline at 90 days and 180 days
Title
Luteinizing hormone (LH) level
Description
Blood test for determining the evolution of this parameter from baseline
Time Frame
Change from baseline at 90 days and 180 days
Title
Glycemia level
Description
Blood test for determining the evolution of this parameter from baseline
Time Frame
Change from baseline at 90 days and 180 days

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Girls aged 6 to 8 years presenting a breast development (isolated or not)
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Paule LEBITASY
Phone
03.20.22.52.69
Ext
+33
Email
lebitasy.marie-paule@ghicl.net
First Name & Middle Initial & Last Name or Official Title & Degree
Elodie MOUTAILLER
Phone
03.20.22.52.69
Ext
+33
Email
moutailler.elodie@ghicl.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia RANNAUD-BARTAIRE, PhD
Organizational Affiliation
Hôpital Saint-Vincent de Paul
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cabinet BLM
City
Lambersart
State/Province
Nord Pas De Calais
ZIP/Postal Code
59130
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia RANNAUD-BARTAIRE, PhD
Email
bartaire.patricia@ghicl.net
First Name & Middle Initial & Last Name & Degree
Patricia RANNAUD-BARTAIRE
Facility Name
Saint Vincent hospital
City
Lille
State/Province
Nord Pas De Calais
ZIP/Postal Code
59000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia RANNAUD-BARTAIRE, PhD
Email
bartaire.patricia@ghicl.net
First Name & Middle Initial & Last Name & Degree
Patricia RANNAUD-BARTAIRE, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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