Patienthèque of Finisterian (South of Brittany) Children With Cystic Fibrosis in the Time of Precision Medicine
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: collection.
- Who it may be relevant to
- Registry conditions: Cystic Fibrosis. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Patienthèque of Finisterian (South of Brittany) Children With Cystic Fibrosis in the Time of Precision Medicine.Descriptive Monocentric Study for Identification and Validation of Biomarkers Predictive of Clinical Evolution
Overview
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.
Detailed description
This is a monocentric study in 3 phases:
* Pre-inclusion: at the first visit to the CRCM (support for a positive screening confirmed by sweat test and genotyping CFTR) * Inclusion: possible between the 2nd visit to the CRCM (about 2 months old) and the 6th month * Follow-up: up to 36 months old. The pace of visits will be based on the usual follow-up rate of CF infants Clinical and paraclinical data and samples will be collected as part of the usual follow-up of CF children. Inclusions and follow-up visits will be carried out at the Roscoff CRCM as well as respiratory explorations and biological samples. Dermatological and odontological follow-ups will be scheduled for each patient at the rate of an annual visit to the CHRU in Brest in the relevant departments.
Interventions
- Diagnostic test collection
bronchial secretions, blood, stools, superficial skin sample, dental plaque sample and urine
Primary outcome measures
- Presence of P. aeruginosa in bacterial sputum cultures in one of bronchial secretions sample [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Fondation Ildys — Roscoff
Identifiers
NCT: NCT04137133 · MUCOthèque (29BRC19.0102)