Monocytes as Predictors of Bone Disease in Cystic Fibrosis
Study of Blood Monocytes as a Predictive Marker of Cystic Fibrosis-related Bone Disease
This study is trying to see if certain immune cells in the blood can help predict bone disease in people with cystic fibrosis compared to healthy individuals.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 20 Years to 65 Years |
| Sex | All |
| Sponsor | Université de Reims Champagne-Ardenne Academic / other |
| Locations | 1 site (Reims) |
| Trial ID | NCT04877223 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between circulating monocytes and the development of bone disease in patients with cystic fibrosis. It will compare the expression levels of specific receptors (RANK and MCSF-R) on monocytes from cystic fibrosis patients to those from healthy controls. The study will utilize flow cytometry to evaluate these expression levels and assess the differentiation of monocytes into osteoclasts. Participants will include patients with cystic fibrosis and healthy donors from the Reims area.
Who should consider this trial
Good fit: Ideal candidates include adults aged 20 to 65 with a confirmed CFTR mutation causing cystic fibrosis.
Not a fit: Patients with medical histories that could compromise the study protocol or those not fluent in French may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better predictive markers for bone disease in cystic fibrosis patients, potentially improving their management and outcomes.
How similar studies have performed: While the specific approach of using monocyte markers in cystic fibrosis-related bone disease is novel, similar studies have shown promise in other conditions involving bone health.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Reims
- Université de Reims Champagne-Ardenne — Reims, France (Recruiting)
Study contacts
- Principal investigator: Bruno RAVONINJATOVO — Centre de Ressources et de Compétences de la Mucoviscidose
- Study coordinator: Bruno RAVONINJATOVO
- Email: bravoninjatovo@chu-reims.fr
- Phone: 03 26 78 38 68
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.