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

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

Recruiting
18 years and younger
All
Phase N/A

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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.

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.

Eligibility

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 details
    Cystic Fibrosis

NCT04137133

University Hospital, Brest

1 May 2024

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