Monocytes as Predictors of Cystic Fibrosis-related Bone Disease

Cystic Fibrosis Clinical Trial

— MucOs  

Official title:

Study of Blood Monocytes as a Predictive Marker of Cystic Fibrosis-related Bone Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04877223
• Other study ID #: 2020-006-MucOs
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: November 1, 2025

Study information

• Verified date: May 2022
• Source: Université de Reims Champagne-Ardenne
• Contact: Bruno RAVONINJATOVO
• Phone: 03 26 78 38 68
• Email: bravoninjatovo[@]chu-reims.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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:

• Main judgment criterion: X Expression level of CD115 (MCSF receptor) and CD265 (RANK) evaluated by flow cytometry receptors on the membranes of circulating monocytes.

• Secondary judgment criteria: X Rate of circulating CD115 +, CD265 +, CD115 + / CD265 + monocytes X Number of multinucleated cells with more than 2 nuclei and with an actin ring observed under fluorescence microscopy after osteoclastic differentiation X Surface of dentin resorbed in vitro by osteoclasts during an osteoclastic functionality test on dentin X Serum S1P levels assayed by ELISA technique.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: November 1, 2025
• Est. primary completion date: November 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patients between 20 and 65 years (+/- 2 years)

• Patients of the CRCM of Reims University Hospital

• Patients with at least one CF causing mutation in CFTR gene

• Patients agreeing to participate in the study (informed consent form)

• Patients fluent in French

• Patients affiliated with a social security regimen

• Healthy donors between 20 and 65 years (+/- 2 years)

• Healthy donors giving blood at EFS GE, Reims

• Healthy donors agreeing to participate in the study (informed consent form)

• Healthy donors fluent in French

• Healthy donors affiliated with a social security regimen

• Healthy donors whose characteristics agree with the ALC/PIL/DIR/AJR /FO/606 convention between EFS GE, Reims, and Reims Champagne-Ardenne University

Exclusion Criteria:

• Patient having a medical history that may compromise the protocol (psychiatric, medical or pharmacological disorders such as the use of anti-inflammatory drugs, or any compound that may alter or modify the inflammatory reaction in the week preceding the protocol).

• Pregnant or breastfeeding women

• Patient with eating disorders (anorexia, bulimia, overeating)

• Patient protected by law (guardianship, curatorship, hospitalized without their consent and not protected by law, deprived of liberty)

Related Conditions & MeSH terms

• Bone Diseases
• Cystic Fibrosis
• Fibrosis

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
France	Université de Reims Champagne-Ardenne	Reims

Sponsors (1)

Lead Sponsor	Collaborator
Université de Reims Champagne-Ardenne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of CD115 and CD265 expression on circulating monocytes	Flow cytometry	Immediately after sampling
Secondary	Assessment of CD115+, CD265+ and CD115+/CD265+ cells	Flow cytometry	Immediately after sampling
Secondary	Count of multinucleated cells with actin ring	Phalloïdin/DAPI staining and microscope observation	3 weeks after sampling
Secondary	Measurement of resorbed dentin surface	Scanning electron microscopy	3 weeks after sampling
Secondary	Measurement of serum S1P concentration	ELISA	Immediately after sampling