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

Regional University Hospital Center (CHRU)

Status: Enrolling

Conditions: Cystic Fibrosis

Treatments: Diagnostic Test: collection

Study type: Interventional

Funder types: Other

Identifiers

NCT04137133

MUCOthèque (29BRC19.0102)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

collection of expectoration, stools and blood

Experimental group

Treatment:

Diagnostic Test: collection