Patienthèque of Finisterian (South of Brittany) Children With Cystic Fibrosis in the Time of Precision Medicine

Study Overview
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Brief Summary
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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
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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 24 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.

Official Title
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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

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Diagnostic Test: collection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: collection of expectoration, stools and blood<br> | Diagnostic Test: collection<br>* bronchial secretions, blood, stools, superficial skin sample, dental plaque sample and urine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 2 years |