Patienthèque of Finisterian (South of Brittany) Children... | NCT04137133

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

NCT04137133

Sponsor

University Hospital, Brest

Status

Recruiting

Last Update Posted

Apr 23, 2024Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Cystic Fibrosis

Interventions

collection

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 21, 2022Actual

Primary Completion Date

Mar 2030Estimated

Completion Date

Mar 2030Estimated

First Submitted Date

Oct 22, 2019

First Submission Date that Met QC Criteria

Oct 22, 2019

First Posted Date

Oct 23, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 22, 2024

Last Update Posted Date

Apr 23, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
collection of expectoration, stools and blood	Experimental		Diagnostic Test: collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
collection	Diagnostic Test	bronchial secretions, blood, stools, superficial skin sample, dental plaque sample and urine	collection of expectoration, stools and blood

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Geneviève HERY-ARNAUD	Contact	0298145102	+33	Genevieve.Hery-Arnaud@univ-brest.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondation Ildys	Recruiting	Roscoff		29684	France

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All collected data that underlie results in a publication

Types

Study Protocol

Time Frame

Data will be available after the publication of result and ending fifteen years following the last visit of the last patient

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.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003550	Cystic Fibrosis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided