Cystic FibrosisEPIMUCONCT02562911
Puberty in Girls Followed for Cystic Fibrosis
An observational study of Cystic Fibrosis, run by University Hospital, Toulouse at 7 sites in France.
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. Read more about this study
- Who is it for?
- Ages 8 years and older, women only
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Data collection
- Type of treatment
- Surgery or procedure
- How many people
- 166 participants
- Where
- 7 sitesFrance
- Study dates
- Jan 2013to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CHU Besançon St Jacques
Besançon
Hôpital des Enfants-Pellegrin
Bordeaux
Hôpital d'Enfants
Dijon
Canton- Hôpitaux de Brabois
Nancy
American Memorial Hospital
Reims
Hôpital de Hautepierre
Strasbourg
Hôpital des enfants Purpan
Toulouse
About this study
Official title: Epidemiological Study of the Progress of Puberty in Girls Followed for Cystic Fibrosis
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.
Read more
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
- Being tested
- Data collection
- Keywords
- cystic fibrosis, menstrual cycle, puberty
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionProcedure or surgery
- 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)
What is being measured
The primary outcome is the main question the study is designed to answer.
The age of menarche in girls followed for cystic fibrosis in France
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study startJan 2013
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine PIENKOWSKI, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562911
- Sponsor's protocol ID
- 12 485 03
- Acronym
- EPIMUCO
- Status last verified
- Mar 2017
- First submitted
- 24 Aug 2015
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study of the Progress of Puberty in Girls Followed for Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02562911
- Acronym / sponsor ID
- EPIMUCO / 12 485 03
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis, menstrual cycle, puberty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 8 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Procedure or surgery | – |
Primary outcome
The age of menarche in girls followed for cystic fibrosis in France
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine PIENKOWSKI, MD principal investigator
University Hospital, Toulouse
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by University Hospital, Toulouse at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The age of menarche in girls followed for cystic fibrosis in France (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2017.