Puberty in Girls Followed for Cystic Fibrosis

Cystic Fibrosis Clinical Trial

— EPIMUCO  

Official title:

Epidemiological Study of the Progress of Puberty in Girls Followed for Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02562911
• Other study ID #: 12 485 03
• Status: Completed
• Phase: N/A
• First received: August 24, 2015
• Last updated: March 12, 2017
• Start date: January 2013
• Est. completion date: December 2015

Study information

• Verified date: March 2017
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

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)

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The age of menarche in girls followed for cystic fibrosis in France		Day 0