Study of Circulating Blood Cell Monocytes as Predictive Biomarker of Bone Cystic Fibrosis Disease. Impact of CFTR Correctors.
NCT ID: NCT03492567
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2018-04-25
2018-07-04
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Blood monocyte precursors/osteoclasts
Blood test
Blood test
Blood draw (max 15 ml)
Interventions
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Blood test
Blood draw (max 15 ml)
Eligibility Criteria
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Inclusion Criteria
* attending the Paris Cochin adult CF centre
* with at least F508del mutation (homozygote or heterozygote patients)
Exclusion Criteria
* absence of signed consent
* patients without a F508del mutation
18 Years
ALL
No
Sponsors
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Vaincre la Mucoviscidose
OTHER
URC-CIC Paris Descartes Necker Cochin
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Dominique HUBERT, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Cochin Hospital
Paris, Paris, France
Countries
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References
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Jourdain ML, Sergheraert J, Braux J, Guillaume C, Gangloff SC, Hubert D, Velard F, Jacquot J. Osteoclastogenesis and sphingosine-1-phosphate secretion from human osteoclast precursor monocytes are modulated by the cystic fibrosis transmembrane conductance regulator. Biochim Biophys Acta Mol Basis Dis. 2021 Mar 1;1867(3):166010. doi: 10.1016/j.bbadis.2020.166010. Epub 2020 Nov 11.
Other Identifiers
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2017-A02965-48
Identifier Type: OTHER
Identifier Source: secondary_id
K171004J
Identifier Type: -
Identifier Source: org_study_id
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