NCT04137133

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.Descriptive Monocentric Study for Identification and Validation of Biomarkers Predictive of Clinical Evolution

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University Hospital, Brest · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	collection	bronchial secretions, blood, stools, superficial skin sample, dental plaque sample and urine

Timeline

• Start date: 2022-03-21
• Primary completion: 2030-03-01
• Completion: 2030-03-01
• First posted: 2019-10-23
• Last updated: 2024-04-23

Locations

1 site across 1 country: France