Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04877223
Status:
RECRUITING
Last Update Posted:
2022-05-18
First Post:
2021-04-27
Brief Title:
Monocytes as Predictors of Cystic Fibrosis-related Bone Disease
Sponsor:
Université de Reims Champagne-Ardenne
Organization:
Université de Reims Champagne-Ardenne
Study Overview
Official Title:
Study of Blood Monocytes as a Predictive Marker of Cystic Fibrosis-related Bone Disease
Status:
RECRUITING
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MucOs
Brief 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 heshe 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 005 will be considered statistically significant
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 heshe 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 005 will be considered statistically significant
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None