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

Not Applicable

Recruiting

• Conditions: Cystic Fibrosis
• Interventions: Diagnostic Test: collection

• Registration Number: NCT04137133
• Lead Sponsor: University Hospital, Brest

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.

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.

Study Timeline

• Study First Submitted: 2019-10-22
• Study First Submitted QC: 2019-10-22
• Study First Posted: 2019-10-23
• Study Start: 2022-03-21
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23
• Primary Completion: 2030-03
• Study Completion: 2030-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
collection of expectoration, stools and blood	collection	-

Primary Outcome Measures

Name	Time	Method
Presence of P. aeruginosa in bacterial sputum cultures in one of bronchial secretions sample	3 years	Analyse with Porphyromonas predictive biomarker of the risk of P. aeruginosa primocolonization.

Trial Locations

Locations (1)

Fondation Ildys; 🇫🇷 Roscoff, France