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

NCT ID: NCT04137133

Last Updated: 2024-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-21

Study Completion Date

2030-03-31

Brief Summary

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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

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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

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Cystic Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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collection of expectoration, stools and blood

Group Type EXPERIMENTAL

collection

Intervention Type DIAGNOSTIC_TEST

bronchial secretions, blood, stools, superficial skin sample, dental plaque sample and urine

Interventions

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collection

bronchial secretions, blood, stools, superficial skin sample, dental plaque sample and urine

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Brest

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondation Ildys

Roscoff, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Geneviève HERY-ARNAUD

Role: CONTACT

0298145102 ext. +33

Facility Contacts

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Audrey BARZIC, Dr

Role: primary

Other Identifiers

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MUCOthèque (29BRC19.0102)

Identifier Type: -

Identifier Source: org_study_id

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