Patienthèque of Finisterian (South of Brittany) Children With Cystic Fibrosis in the Time of Precision Medicine (MUCOthèque)
Primary Purpose
Cystic Fibrosis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
collection
Sponsored by
About this trial
This is an interventional diagnostic trial for Cystic Fibrosis
Eligibility Criteria
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
Sites / Locations
- Fondation IldysRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
collection of expectoration, stools and blood
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04137133
First Posted
October 22, 2019
Last Updated
July 12, 2022
Sponsor
University Hospital, Brest
1. Study Identification
Unique Protocol Identification Number
NCT04137133
Brief Title
Patienthèque of Finisterian (South of Brittany) Children With Cystic Fibrosis in the Time of Precision Medicine
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
March 2029 (Anticipated)
Study Completion Date
March 2029 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 24 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
collection of expectoration, stools and blood
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
collection
Intervention Description
bronchial secretions, blood, stools, superficial skin sample, dental plaque sample and urine
Primary Outcome Measure Information:
Title
Presence of P. aeruginosa in bacterial sputum cultures in one of bronchial secretions sample
Description
Analyse with Porphyromonas predictive biomarker of the risk of P. aeruginosa primocolonization.
Time Frame
2 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Geneviève HERY-ARNAUD
Phone
0298145102
Ext
+33
Email
Genevieve.Hery-Arnaud@univ-brest.fr
Facility Information:
Facility Name
Fondation Ildys
City
Roscoff
ZIP/Postal Code
29684
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Audrey BARZIC, Dr
Email
audrey.barzic@ildys.org
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected data that underlie results in a publication
IPD Sharing Time Frame
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
IPD Sharing Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.
Learn more about this trial
Patienthèque of Finisterian (South of Brittany) Children With Cystic Fibrosis in the Time of Precision Medicine
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