NCT05726994|Completed
Volatilomic Approaches for the Study of CFTR Modulators (VOLATIL-CF)
VOLATIL-CF
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VOLATIL-CF
Sponsor study identifier
observational
50
1 country
1
Study Start
February 6, 2023
Actual (reported)Primary Completion
July 4, 2024
Actual (reported)Study Completion
July 4, 2024
Actual (reported)This study relies on the hypotheses that (1) exhaled breath is intimately correlated to the patient's lung condition and that (2)the composition of exhaled breath , i.e. the VOCs profile, will be significantly modified from the first days of treatment by CFTR modulators in a or pauci/symptomatic patients such as young children under 12 years old. The non-invasive and longitudinal collection and analysis of exhaled breath may reveal modifications in signaling pathways impacted by these treatments on the very short term. This study is a single-center pilot study.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 4, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 12, 2023
Actual (reported)February 6, 2023
Actual (reported)February 14, 2023
Actual (reported)July 4, 2024
Actual (reported)July 4, 2024
Actual (reported)volatile organic compounds (VOC) profile
identification of VOCs in exhaled breath with a significant variation between 0 day, 7 days, and/or 1 month of treatment
At 0 day, 7 days, and 1 month of treatment
Weight
At 0 day, 7 days, and 1 month of treatment
Sweat test
At 0 day, 7 days, and 1 month of treatment
Induced sputum - microbiology
At 0 day, 7 days, and 1 month of treatment
Induced sputum - immunology
At 0 day, 7 days, and 1 month of treatment
Spirometry
At 0 day, 7 days, and 1 month of treatment
20 children with cystic fibrosis aged 6 to 12 who initiate Kaftrio®
Fasting children will be asked to breathe normally through a mouthpiece for the collection and analysis of exhaled breath.
Clinical data will be collected in order to seek correlations with the exhaled breath profile.
Children with cystic fibrosis aged 6 to 12 who will start Kaftrio® treatment.
Hôpital Necker - Enfants malades
Paris, Île-de-France Region, 75015, France
Induced sputum, Plasma, Urine
Isabelle SERMET-GAUDELUS, Professor
APHP
50 participants (actual enrollment reported by the registry).
First Submitted
January 12, 2023
First Posted
February 14, 2023
Study Start
February 6, 2023
Actual (reported)Concerns of Children Whose Parents Have Cystic Fibrosis
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
July 4, 2024
Actual (reported)Study Completion
July 4, 2024
Actual (reported)Last Updated
July 1, 2026
Record last verified: 2026-06
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Source: ClinicalTrials.gov.
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