An observational study in Cystic Fibrosis, sponsored by Université de Reims Champagne-Ardenne. Recruiting at 1 site in France. Open to participants aged 20 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-18.
Sponsored by Université de Reims Champagne-Ardenne · Observational
Hypothesis: Circulating monocytes RANK and MCSF-R expression is predictive of Cystic Fibrosis-related Bone Disease.
Study design: Single-center comparative cross-sectional study Population: Patients with a CFTR channel mutation causing cystic fibrosis consulting the Centre de Ressources et de Compétences de la Mucoviscidose (CRCM) at Reims University Hospital will be recruited. Healthy controls will be recruited from donors at the Etablissement Français du Sang Grand Est, Reims.
Judgment criteria:
Investigation plan:
Any eligible patient will be offered to participate in the study during the consultation at the CRCM. If the patient agrees to participate in the study, he/she will be included. Participation in the study will not affect its coverage. Participation will lead to the collection of three tubes of whole blood additional to those used as part of usual care, as well as the collection of demographic data (age, sex, height, weight, body mass index), sports practice, clinical images and interpretation, medical history (diabetes, infectious status, bone metabolism disorders, drug treatments followed, psychiatric disorders). Any subsequent donor from the EFS GE collected under the ALC / PIL / DIR / AJR / FO / 606 agreement and presenting characteristics of age +/- 2 years and identical gender will then be included.
Statistical analysis plan:
Qualitative variables will be described in terms of number and percentage. The quantitative distribution variables according to the Normal law will be described in the form of mean +/- standard deviation or in the form of boxplots (median, quartiles, deciles) if a distribution not following the Normal law is observed. ANOVA test, non-parametric Wilcoxon signed-rank test or chi² test will be aplied depending on the application conditions. A value of p \<0.05 will be considered statistically significant.
1,619 studies on the registry are indexed under Cystic Fibrosis; 199 are open to participants now.
This study's planned enrollment of 80 is close to the median of 85 across 503 observational studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Université de Reims Champagne-Ardenne is the lead sponsor of 64 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Cystic fibrosis patients consulting the CRCM of Reims University Hospital. Healthy controls from Etablissement Français du Sang Grand Est, Reims
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with Cystic Fibrosis
Other: No intervention
No intervention
Assessment of CD115 and CD265 expression on circulating monocytes
Flow cytometry
Time frame: Immediately after sampling
Assessment of CD115+, CD265+ and CD115+/CD265+ cells
Flow cytometry
Time frame: Immediately after sampling
Count of multinucleated cells with actin ring
Phalloïdin/DAPI staining and microscope observation
Time frame: 3 weeks after sampling
Measurement of resorbed dentin surface
Scanning electron microscopy
Time frame: 3 weeks after sampling
Measurement of serum S1P concentration
ELISA
Time frame: Immediately after sampling
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Université de Reims Champagne-Ardenne