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NCT Number: NCT04137133

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

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.

Recruiting

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondation Ildys

Roscoff, 29684, France

Location status: Recruiting

Location contact

Audrey BARZIC, Dr

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

collection

Diagnostic Test

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

Primary outcomes

  1. Presence of P. aeruginosa in bacterial sputum cultures in one of bronchial secretions sample

    Time frame: 3 years

    Analyse with Porphyromonas predictive biomarker of the risk of P. aeruginosa primocolonization.

Study contacts

Contact information is provided by the study sponsor or research team.

Geneviève HERY-ARNAUD

CONTACT

[email protected]

0298145102 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study 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

Acronym: MUCOthèque

Important dates

Study start
2022
Primary completion
2030
Study completion
2030
First posted
Oct 23, 2019
Registry last updated
Apr 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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