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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03565692 |
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Date of registration:
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31/05/2018 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Lum-Iva-biota: Exploring the Respiratory Mycobiota and Microbiota Profile in French CF Patients Taking Lumacaftor-Ivacaftor
Lum-Iva-Biota |
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Scientific title:
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Lum-Iva-biota: Exploring the Respiratory Mycobiota and Microbiota Profile in French CF Patients Taking Lumacaftor-Ivacaftor |
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Date of first enrolment:
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July 1, 2018 |
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Target sample size:
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250 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03565692 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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France
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Contacts
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Name:
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Laurence DELHAES, MD, PhD |
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Address:
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Telephone:
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+335 56 79 56 67 |
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Email:
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laurence.delhaes@chu-bordeaux.fr |
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Affiliation:
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Name:
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Laurence DELHAES, MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Bordeaux |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- CF Patient's ability to expectorate at inclusion time
- CF patient treated with an ivacaftor combination (lumacaftor/ivacaftor or new
generation combination) for a period of at least 1 year and managed by the National
working group "New therapeutic approaches" under the National CF Observatory and who
haven't expressed a non-opposition to the secondary use of their sputum and stool
samples in the context on Lum-Iva-biota project.
Exclusion Criteria:
- CF patient who stop ivacaftor combination treatment.
- CF patient who doesn't want to participate anymore to Lum-Iva-Biota
Age minimum:
2 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Biological: the gut mycobiota and microbiota profile
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Biological: the lung mycobiota and microbiota profile
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Primary Outcome(s)
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Change of specific bacterial and/or fungal pathogens
[Time Frame: 18 months]
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Secondary Outcome(s)
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Forced expiratory volume (FEV1)
[Time Frame: 12 Months]
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Forced expiratory volume (FEV1)
[Time Frame: 6 Months]
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Change of specific bacterial and/or fungal pathogens
[Time Frame: 12 months]
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Forced expiratory volume in 1 second (FEV1)
[Time Frame: Day 1]
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Secondary ID(s)
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CHUBX 2016/22
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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