Patienthèque of Finisterian (South of Brittany) Children With Cystic Fibrosis in the Time of Precision Medicine
MUCOthèque
1 other identifier
interventional
20
1 country
1
Brief Summary
The objective of this study is to evaluate the relevance of Porphyromonas as a biomarker predicting the risk of P. aeruginosa primocolonization in children form 0 to 18 years old with cystic fibrosis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2022
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2019
CompletedFirst Posted
Study publicly available on registry
October 23, 2019
CompletedStudy Start
First participant enrolled
March 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2030
April 23, 2024
April 1, 2024
8 years
October 22, 2019
April 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Presence of P. aeruginosa in bacterial sputum cultures in one of bronchial secretions sample
Analyse with Porphyromonas predictive biomarker of the risk of P. aeruginosa primocolonization.
3 years
Study Arms (1)
collection of expectoration, stools and blood
EXPERIMENTALInterventions
bronchial secretions, blood, stools, superficial skin sample, dental plaque sample and urine
Eligibility Criteria
You may qualify if:
- Newly screened infants with a confirmed diagnosis of cystic fibrosis in its classic form (clinical symptoms and two positive sweat tests and/or two mutations of the cftr gene from Class I to III)
- Children free of any colonization with P. aeruginosa
- Affiliation with the social security system
- Consent signed by the holders of parental authority or the sole parent holding parental authority
You may not qualify if:
- Children colonized with P. aeruginosa according to the cytobacteriological examination and / or molecular test of sputum or pharyngeal specimens
- Children grafted
- Children not affiliated to a social security scheme or not entitled to
- Children whose parent (s) are (are) minor (s)
- Children whose holders of parental authority do not master the French language
- Refusal to participate in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fondation Ildys
Roscoff, 29684, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2019
First Posted
October 23, 2019
Study Start
March 21, 2022
Primary Completion (Estimated)
March 1, 2030
Study Completion (Estimated)
March 1, 2030
Last Updated
April 23, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
- Access Criteria
- Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
All collected data that underlie results in a publication