NCT05654480|Unknown
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Sponsor study identifier
observational
400
1 country
1
Study Start
January 2, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
After cystic fibrosis (CF) neonatal screening, some children remain with a not concluded diagnosis. In France, the medical follow-up is not standardized, some of them may be lost of follow-up. The aim of the study is to identify children at risk of developing CF. Other children carry mutation at risk of CFTR related disorder (CFTR-RD) but remain asymptomatic during childhood. The aim of the study is to evaluate those children by microbiology, respiratory function test and lung imaging tests to reclassify them in the CFTR spectrum.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 25, 2022
Actual (reported)December 16, 2022
Actual (reported)January 2, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
sputum bacteriology
bacteria, fungi and mycobacteria
previous and at inclusion
spirometry
previous and at inclusion
Lung Clearance index (LCI)
previous and at inclusion
Plethysmography
previous and at inclusion
lung imaging
previous and at inclusion
sweat test
previous and at inclusion
Adult patients and pediatric patients evaluated at neonatal screening and : 1\) either an intermediate chloride sweat test (30-59 mmol/L) and at most one CFTR mutation (2) or negative chloride sweat test (\< 30 mmol/L) and two CFTR mutations one of wich is of unknown significance (VUS) Adult and pediatric patients carrying at least two CFTR mutations one of which at least is of Varying Clinical Consequence according to "CFTR2" database or "CFTR-RD" according to "CFTR-France" database.
Necker Hospital
Paris, 75014, France
Christophe Marguet, MD
Societe Francaise de la Mucoviscidose
First Submitted
November 25, 2022
First Posted
December 16, 2022
Study Start
January 2, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
May 1, 2024
Patienthèque of Finisterian (South of Brittany) Children With Cystic Fibrosis in the Time of Precision Medicine
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 31, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 16, 2022
Record last verified: 2022-12
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Source: ClinicalTrials.gov.
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