Back to resultsStudy of Circulating Blood Cell Monocytes as Predictive Biomarker of Bone Cystic Fibrosis Disease. Impact of CFTR Correctors. (MUCO-OS)
Primary Purpose
Cystic Fibrosis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood test
Sponsored by
About this trial
This is an interventional basic science trial for Cystic Fibrosis focused on measuring Cystic fibrosis, CFTR, CFTR modulators, Monocyte, Osteoclast, Osteoporosis
Eligibility Criteria
Inclusion Criteria:
- patients with cystic fibrosis
- attending the Paris Cochin adult CF centre
- with at least F508del mutation (homozygote or heterozygote patients)
Exclusion Criteria:
- patients younger than 18
- absence of signed consent
- patients without a F508del mutation
Sites / Locations
- Cochin Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Blood monocyte precursors/osteoclasts
Arm Description
Blood test
Outcomes
Primary Outcome Measures
Phenotype of CD14 monocytes/osteoclasts
Secondary Outcome Measures
In vitro test of CFTR modulators
Full Information
NCT ID
NCT03492567
First Posted
April 3, 2018
Last Updated
November 20, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Vaincre la Mucoviscidose
1. Study Identification
Unique Protocol Identification Number
NCT03492567
Brief Title
Study of Circulating Blood Cell Monocytes as Predictive Biomarker of Bone Cystic Fibrosis Disease. Impact of CFTR Correctors.
Acronym
MUCO-OS
Official Title
Study of Circulating Monocytes as Predictive Biomarker of Osteoclastogenesis in Cystic Fibrosis-related Bone Loss. Impact of CFTR Correctors.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
April 25, 2018 (Actual)
Primary Completion Date
July 4, 2018 (Actual)
Study Completion Date
July 4, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Vaincre la Mucoviscidose
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Cystic fibrosis, CFTR, CFTR modulators, Monocyte, Osteoclast, Osteoporosis
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blood monocyte precursors/osteoclasts
Arm Type
Experimental
Arm Description
Blood test
Intervention Type
Biological
Intervention Name(s)
Blood test
Intervention Description
Blood draw (max 15 ml)
Primary Outcome Measure Information:
Title
Phenotype of CD14 monocytes/osteoclasts
Time Frame
1 day
Secondary Outcome Measure Information:
Title
In vitro test of CFTR modulators
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with cystic fibrosis
attending the Paris Cochin adult CF centre
with at least F508del mutation (homozygote or heterozygote patients)
Exclusion Criteria:
patients younger than 18
absence of signed consent
patients without a F508del mutation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dominique HUBERT, PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cochin Hospital
City
Paris
ZIP/Postal Code
75014
Country
France
12. IPD Sharing Statement
Learn more about this trial
Study of Circulating Blood Cell Monocytes as Predictive Biomarker of Bone Cystic Fibrosis Disease. Impact of CFTR Correctors.
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