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临床试验/NCT03492567
NCT03492567已完成不适用

Study of Circulating Monocytes as Predictive Biomarker of Osteoclastogenesis in Cystic Fibrosis-related Bone Loss. Impact of CFTR Correctors.

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2018年4月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
1
主要终点
Phenotype of CD14 monocytes/osteoclasts

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with cystic fibrosis
  • attending the Paris Cochin adult CF centre
  • with at least F508del mutation (homozygote or heterozygote patients)

排除标准

  • patients younger than 18
  • absence of signed consent
  • patients without a F508del mutation

研究组 & 干预措施

Blood monocyte precursors/osteoclasts

Experimental

Blood test

干预措施: Blood test (Biological)

结局指标

主要结局

Phenotype of CD14 monocytes/osteoclasts

时间窗: 1 day

次要结局

  • In vitro test of CFTR modulators(1 day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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