Evaluating a biomarker for cystic fibrosis in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the relevance of Porphyromonas as a biomarker for predicting the risk of P. aeruginosa colonization in children aged 0 to 18 years with cystic fibrosis. It is a monocentric study conducted in three phases: pre-inclusion, inclusion, and follow-up, with data and samples collected during routine clinical visits. The study will take place at the Roscoff CRCM, where clinical and paraclinical evaluations will be performed, along with annual dermatological and odontological follow-ups at the CHRU in Brest.

Why it matters

Who can join: the full rules

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

Where it's running

• Fondation Ildys
  Roscoff, France Recruiting

Study contacts

• Study coordinator: Geneviève HERY-ARNAUD
• Email: Genevieve.Hery-Arnaud@univ-brest.fr
• Phone: 0298145102

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.