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Clinical Trials in France / NCT02965326
Recruiting Not applicable

Surrogate Markers of Response to New Therapies in Cystic Fibrosis Patients

NCT02965326 · tracked via the Priya Life Science France tracker
Sponsor
Hôpital Necker-Enfants Malades
Phase
Not applicable
Started
2016-05
Last updated
2024-03-12

Condition(s) studied

Cystic Fibrosis

Investigational drug(s) / intervention(s)

Nasal swab; rectal biopsy.

Nasal swab; rectal biopsy.: Nasal epithelial cells will be obtained by nasal swabs from patients of the three arms; intestinal epithelial cells will be obtained, by rectal biopsy, only from patients treated by CFTR modulators.

Study summary

The purpose of this study is to determine which biological marker, or association of biological markers, best predict clinical response of cystic fibrosis patients to CFTR modulators.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Cystic fibrosis patients treated by CFTR modulators (Ivacaftor or the association Ivacaftor-Lumacaftor) * Cystic fibrosis patients non treated by CFTR modulators * Patients in whom cystic fibrosis diagnosis has been suspected, but excluded by physiological and genetic investigations Exclusion Criteria: * pregnant or lactating women * contraindication to nasal swab * contraindication to rectal biopsy

Primary outcome measure(s)

  • Forced Expiratory Volume in 1 second — initiation, 7 days, 1 month, 6 months, 1 year and every 6 months
    Respiratory Function test

Trial sites (1)

FacilityCityRegionStatus
Necker Hospital Paris France Recruiting

More Hôpital Necker-Enfants Malades trials in France

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Mechanisms of Fecal Incontinence in Wolfram Syndrome Starting soon
Metabolomics Analysis According to the Retinal Nerve Fiber Layer in Patients With NOHL Mutations (MétabOCT) Recruiting

Other trials for the same condition

Identification of Dysglycemia With Continuous Glucose Monitoring to Assess Clinical Evolution in Cystic Fibrosis Recruiting
Physical Activity Profile and Sedentary Behaviour in Adults With Cystic Fibrosis Recruiting
Intestine-lung Axis of Cystic Fibrosis Patients Treated With the Combination Elexacaftor/Tezacaftor/Ivacaftor Recruiting
Study to Evaluate Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) Long-term Safety and Efficacy in Subjects Without F508del Active, not recruiting
Establishment of a Primary Epididymal Cell Model From Epididymal Samples to Study CFTR Gene Regulation Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02965326 on ClinicalTrials.gov ↗ ← All trials in France