Evaluating a biomarker for cystic fibrosis in children
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
NA · University Hospital, Brest · NCT04137133
This study is testing whether a specific biomarker can help predict the risk of lung infections in children with cystic fibrosis.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | University Hospital, Brest (other) |
| Locations | 1 site (Roscoff) |
| Trial ID | NCT04137133 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the relevance of Porphyromonas as a biomarker for predicting the risk of P. aeruginosa colonization in children aged 0 to 18 years with cystic fibrosis. It is a monocentric study conducted in three phases: pre-inclusion, inclusion, and follow-up, with data and samples collected during routine clinical visits. The study will take place at the Roscoff CRCM, where clinical and paraclinical evaluations will be performed, along with annual dermatological and odontological follow-ups at the CHRU in Brest.
Who should consider this trial
Good fit: Ideal candidates are newly diagnosed infants with classic cystic fibrosis who are not colonized with P. aeruginosa.
Not a fit: Patients who are already colonized with P. aeruginosa or have undergone grafting will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early identification of children at risk for severe lung infections, enhancing their management and outcomes.
How similar studies have performed: While the approach of using biomarkers in cystic fibrosis is being explored, this specific study's focus on Porphyromonas is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Roscoff
- Fondation Ildys — Roscoff, France (RECRUITING)
Study contacts
- Study coordinator: Geneviève HERY-ARNAUD
- Email: Genevieve.Hery-Arnaud@univ-brest.fr
- Phone: 0298145102
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cystic Fibrosis