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

Cystic Fibrosis Clinical Trial

— MUCOthèque  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04137133
• Other study ID #: MUCOthèque (29BRC19.0102)
• Status: Recruiting
• Phase: N/A
• Start date: March 21, 2022
• Est. completion date: March 2030

Study information

• Verified date: April 2024
• Source: University Hospital, Brest
• Contact: Geneviève HERY-ARNAUD
• Phone: 0298145102
• Email: Genevieve.Hery-Arnaud[@]univ-brest.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: March 2030
• Est. primary completion date: March 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Diagnostic Test:
• collection
bronchial secretions, blood, stools, superficial skin sample, dental plaque sample and urine

Locations

Country	Name	City	State
France	Fondation Ildys	Roscoff

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of P. aeruginosa in bacterial sputum cultures in one of bronchial secretions sample	Analyse with Porphyromonas predictive biomarker of the risk of P. aeruginosa primocolonization.	3 years