Study of Circulating Blood Cell Monocytes as Predictive Biomarker of Bone Cystic Fibrosis Disease. Impact of CFTR Correctors. (MUCO-OS)
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|ClinicalTrials.gov Identifier: NCT03492567|
Recruitment Status : Completed
First Posted : April 10, 2018
Last Update Posted : November 21, 2018
The aim of the study is to look for risk factors of developing osteoporosis in patients with cystic fibrosis.
Blood cells called monocytes will be obtained from a blood sample. These monocytes will make possible to form another class of cells called osteoclasts in the laboratory. These latter cells are responsible for bone degradation and therefore promote the increase of bone fragility. The research will focus on the characterization of these cells to better understand their potential (low, medium or high) to increase bone fragility in patients with cystic fibrosis.
Finally the action of CFTR modulators on these bone cells will be tested.
|Condition or disease||Intervention/treatment||Phase|
|Cystic Fibrosis||Biological: Blood test||Not Applicable|
The aim of the study is to characterize the profile of circulating monocytes as predictive biomarker of osteoclastogenesis in CF related bone disease.
Investigators will evaluate the presence and regulation of CD115 (MCSF receptor) and CD265 (RANK) membrane receptors of circulating monocytes of cystic fibrosis patients.
They will also analyze the impact of the F508del CFTR mutation on the differentiation of monocytes into osteoclasts. We will 1) Quantify the training and functional activity of osteoclasts and, 2) Test in vitro the effects of correctors and potentiators of CFTR on the resorption activity of differentiated osteoclasts.
The study will be explained to patients and they only will have one blood test.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Study of Circulating Monocytes as Predictive Biomarker of Osteoclastogenesis in Cystic Fibrosis-related Bone Loss. Impact of CFTR Correctors.|
|Actual Study Start Date :||April 25, 2018|
|Actual Primary Completion Date :||July 4, 2018|
|Actual Study Completion Date :||July 4, 2018|
Experimental: Blood monocyte precursors/osteoclasts
Biological: Blood test
Blood draw (max 15 ml)
- Phenotype of CD14 monocytes/osteoclasts [ Time Frame: 1 day ]
- In vitro test of CFTR modulators [ Time Frame: 1 day ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03492567
|Paris, France, 75014|
|Principal Investigator:||Dominique HUBERT, PhD||Assistance Publique - Hôpitaux de Paris|