Cystic FibrosisMucOsNCT04877223
Monocytes as Predictors of Cystic Fibrosis-related Bone Disease
An observational study of Cystic Fibrosis, run by Université de Reims Champagne-Ardenne at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2021to 1 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Cystic fibrosis patients consulting the CRCM of Reims University Hospital. Healthy controls from Etablissement Français du Sang Grand Est, Reims
Who may be able to join
- Patients between 20 and 65 years (+/- 2 years)
- Patients of the CRCM of Reims University Hospital
- Patients with at least one CF causing mutation in CFTR gene
- Patients agreeing to participate in the study (informed consent form)
- Patients fluent in French
- Patients affiliated with a social security regimen
Show all 12Show fewer
- Healthy donors between 20 and 65 years (+/- 2 years)
- Healthy donors giving blood at EFS GE, Reims
- Healthy donors agreeing to participate in the study (informed consent form)
- Healthy donors fluent in French
- Healthy donors affiliated with a social security regimen
- Healthy donors whose characteristics agree with the ALC/PIL/DIR/AJR /FO/606 convention between EFS GE, Reims, and Reims Champagne-Ardenne University
Who cannot join
- Patient having a medical history that may compromise the protocol (psychiatric, medical or pharmacological disorders such as the use of anti-inflammatory drugs, or any compound that may alter or modify the inflammatory reaction in the week preceding the protocol).
- Pregnant or breastfeeding women
- Patient with eating disorders (anorexia, bulimia, overeating)
- Patient protected by law (guardianship, curatorship, hospitalized without their consent and not protected by law, deprived of liberty)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Université de Reims Champagne-Ardenne
Reims
Frédéric VELARD, 03 26 91 80 10, frederic.velard@univ-reims.fr
About this study
Official title: Study of Blood Monocytes as a Predictive Marker of Cystic Fibrosis-related Bone Disease
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.
Read more
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, he/she 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 <0.05 will be considered statistically significant.
- Conditions
- Cystic Fibrosis
- Being tested
- No intervention
- Keywords
- Cystic Fibrosis, Bone disease, Monocytes, RANK, MCSF-R, Osteoclast
- Medical subject headings
- Cystic Fibrosis, Bone Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| CF | Patients with Cystic Fibrosis Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of CD115 and CD265 expression on circulating monocytes
Flow cytometry
Measured: Immediately after sampling
Secondary outcomes (4)
Assessment of CD115+, CD265+ and CD115+/CD265+ cells
Flow cytometry
Measured: Immediately after sampling
Count of multinucleated cells with actin ring
Phalloïdin/DAPI staining and microscope observation
Measured: 3 weeks after sampling
Measurement of resorbed dentin surface
Scanning electron microscopy
Measured: 3 weeks after sampling
Measurement of serum S1P concentration
ELISA
Measured: Immediately after sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start1 Jun 2021
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Reims Champagne-Ardenne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno RAVONINJATOVO, Principal investigator, Centre de Ressources et de Compétences de la Mucoviscidose
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04877223
- Sponsor's protocol ID
- 2020-006-MucOs
- Acronym
- MucOs
- Status last verified
- May 2022
- First submitted
- 27 Apr 2021
- Last updated
- 18 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Blood Monocytes as a Predictive Marker of Cystic Fibrosis-related Bone Disease
- ClinicalTrials.gov ID
- NCT04877223
- Acronym / sponsor ID
- MucOs / 2020-006-MucOs
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis, Bone disease, Monocytes, RANK, MCSF-R, Osteoclast
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Université de Reims Champagne-ArdenneUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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, he/she 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 <0.05 will be considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CF | – | Other: No interventionPatients with Cystic Fibrosis |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Cystic fibrosis patients consulting the CRCM of Reims University Hospital. Healthy controls from Etablissement Français du Sang Grand Est, Reims
Key inclusion criteria (12 listed)
- Patients between 20 and 65 years (+/- 2 years)
- Patients of the CRCM of Reims University Hospital
- Patients with at least one CF causing mutation in CFTR gene
- Patients agreeing to participate in the study (informed consent form)
- Patients fluent in French
Key exclusion criteria (4 listed)
- Patient having a medical history that may compromise the protocol (psychiatric, medical or pharmacological disorders such as the use of anti-inflammatory drugs, or any compound that may alter or modify the inflammatory reaction in the week preceding the protocol).
- Pregnant or breastfeeding women
- Patient with eating disorders (anorexia, bulimia, overeating)
- Patient protected by law (guardianship, curatorship, hospitalized without their consent and not protected by law, deprived of liberty)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | CF |
Primary outcome
Assessment of CD115 and CD265 expression on circulating monocytes
Time frame: Immediately after sampling
Flow cytometry
4 secondary outcomes
Assessment of CD115+, CD265+ and CD115+/CD265+ cells
Time frame: Immediately after sampling
Count of multinucleated cells with actin ring
Time frame: 3 weeks after sampling
Measurement of resorbed dentin surface
Time frame: 3 weeks after sampling
Measurement of serum S1P concentration
Time frame: Immediately after sampling
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
Related trials for Cystic Fibrosis
RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
Non-cystic Fibrosis Bronchiectasis
Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
Cystic Fibrosis, Bone Loss
RecruitingObservational study
Natural History of Bronchiectasis
Bronchiectasis, Cystic Fibrosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
Cystic Fibrosis - Complete
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno RAVONINJATOVO principal investigator
Centre de Ressources et de Compétences de la Mucoviscidose
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cystic Fibrosis, run by Université de Reims Champagne-Ardenne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruno RAVONINJATOVO (03 26 78 38 68, bravoninjatovo@chu-reims.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of CD115 and CD265 expression on circulating monocytes (time frame: Immediately after sampling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2022.