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Puberty in Girls Followed for Cystic Fibrosis (EPIMUCO)

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ClinicalTrials.gov Identifier: NCT02562911
Recruitment Status : Completed
First Posted : September 29, 2015
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:

In the general population, age of puberty, and age of menarche in girls, are closely correlated with those of their mother. The severity of chronic disease has an impact on the stature, the weight gain and the onset of puberty: age of menarche is even later that chronic illness is serious. Cystic fibrosis is one of the major chronic diseases of children.

Neonatal screening is organized since 2002, most girls with cystic fibrosis therefore currently have a very specialized and early care. Older patients were diagnosed during childhood. The optimization of the nutritional and respiratory management has allowed over the past two decades a significant improvement in the survival of these patients. Most young people reach adulthood, puberty and reproductive desire are a crucial issue in the care of these young adults.

In literature, it is often noted an age of menarche delayed an average of 2 years compared to the general population, but correlated with the age of menstruation from the mothers.

The factors involved in the conduct of cycles in the girl followed for cystic fibrosis are poorly known and there are few data on the characteristics of cycles. The menstrual irregularity and amenorrhoea episodes concern nearly half of women.

On the pathophysiological level, studies in animals show that there is a direct effect of CFTR (Cystic Fibrosis Transmembrane Regulator) on the hypothalamic pituitary gonadal and reproductive capacity in mice.

The literature data on the pubertal development, fertility and hormonal profile of these girls are for studies with low numbers and are very old. There is to date no French cohort study on this topic.

The study is a multicenter cross-sectional descriptive study for pubertal and gynecological characteristics in girls followed annually in the reference centers Cystic Fibrosis two inter-region.


Condition or disease Intervention/treatment
Cystic Fibrosis Procedure: Data collection

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Study Type : Observational
Actual Enrollment : 166 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiological Study of the Progress of Puberty in Girls Followed for Cystic Fibrosis
Study Start Date : January 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Data collection
    • Clinical examination
    • Complete pelvic ultrasound abdominal ultrasound
    • Bone age: X-ray
    • biological examination
    • Lung function assessed by the Maximum Volume Expired
    • Brasfield radiological score (if available)


Primary Outcome Measures :
  1. The age of menarche in girls followed for cystic fibrosis in France [ Time Frame: Day 0 ]


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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Girl aged 8 years of age, adolescents and young adults, had period or not, visit the Reference and Competence Center of Cystic Fibrosis.
Criteria

Inclusion Criteria:

  • Patient diagnosed with cystic fibrosis
  • Girl aged 8 years of age, adolescents and young adults, had period or not,
  • visit the Reference and Competence Center of Cystic Fibrosis.
  • Affiliated to a social security scheme

Exclusion Criteria:

  • Lack of consent of the legal representative or the relevant patient.
  • Patient majoring in legal disability or minor patient whose legal representative is legal disability

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562911


Locations
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France
CHU Besançon St Jacques
Besancon, France
Hôpital des Enfants-Pellegrin
Bordeaux, France
Hôpital d'Enfants
Dijon, France
Canton- Hôpitaux de Brabois
Nancy, France
American Memorial Hospital
Reims, France
Hôpital de Hautepierre
Strasbourg, France
Hôpital des enfants Purpan
Toulouse, France
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
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Principal Investigator: Catherine PIENKOWSKI, MD University Hospital, Toulouse

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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02562911     History of Changes
Other Study ID Numbers: 12 485 03
First Posted: September 29, 2015    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Keywords provided by University Hospital, Toulouse:
cystic fibrosis
menstrual cycle
puberty
Additional relevant MeSH terms:
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Cystic Fibrosis
Fibrosis
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Lung Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases