Assessment of Patients Not Concluded After Neonatal Screening of Cystic Fibrosis.
ConditionCFTR-RD
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorHôpital Necker-Enfants Malades
About this trial
Assessment of the outcome of patients not concluded fir cystic fibrosis, either symptomatic patients or asymptomatic children detected by newborn screening for cystic fibrosis. The aim is to identify patients potentially at risk of progressing to the clinical spectrum of cystic fibrosis
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
patients carrying 2 CF causing variants of the CFTR gene
patients carrying only 1 or no variants of CFTR
Trial population
children of adults not concluded for the diagnosis of Cystic fibrosis
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
data collection
Other interventioncollection of data of generated by "real world" follow up
Treatment groups
400 Participants
are divided into 1 treatment groupGroup A: patients with unconcluded diagnosis for cystic fibrosis1 intervention
Trial outcomes
Primary outcomes
1
lung Imaging
abnormal lung Imaging score, assessing the area of the lung with bronchiectasis, bronchial wall thickening, mucus plug and air trapping
Time frame
within 3 months after visitSecondary outcomes
1
lung infection
sputum bacterial colonization (number of Colony Forming Unit) of bacteria, fungi
Time frame
within 2 weeks after visit2
pancreatic function
fecal elastase in µg/g of feces
Time frame
within 2 weeks after visitLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: