Puberty in Girls Followed for Cystic Fibrosis

NCT02562911 | Completed

• 1 other identifier: 12 485 03
• Study Type: observational
• Target: 166
• Locations: 1 country
• Sites: 7

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.

Conditions

Cystic Fibrosis

Keywords

cystic fibrosis; menstrual cycle; puberty

Outcome Measures

Primary Outcomes (1)

• The age of menarche in girls followed for cystic fibrosis in France

  Day 0

Interventions

Data collection PROCEDURE

* 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)

Eligibility Criteria

• Age: 8 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (7)

CHU Besançon St Jacques

Besançon, France

Location

Hôpital des Enfants-Pellegrin

Bordeaux, France

Location

Hôpital d'Enfants

Dijon, France

Location

Canton- Hôpitaux de Brabois

Nancy, France

Location

American Memorial Hospital

Reims, France

Location

Hôpital de Hautepierre

Strasbourg, France

Location

Hôpital des enfants Purpan

Toulouse, France

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Catherine PIENKOWSKI, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2015
• First Posted: September 29, 2015
• Study Start: January 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: March 14, 2017

Record last verified: 2017-03

Locations

FR (7)