Cystic FibrosisMucoNETsNCT02564393
Induction of Neutrophilic Traps ( NETs ) by the Environment and Infectious Inflammatory Lung Cystic Fibrosis
An observational study of Cystic Fibrosis, run by University Hospital, Tours at 1 site in France.
Trial summary
The study is defined in 3 stages of in vitro assays : Phase 1 : Secretion of NETs in response to lung disease and their secretion of factors. This is a transversal study in which we compare : Producing NETs (DNA and proteases ) by neutrophils purified from sputum and blood of patients Producing NETs (DNA and proteases… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- May 2011to May 2013
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pathophysiological study comparing a " Cystic fibrosis " group to a control group (adults)
Who may be able to join
- Patients :
- Men or women over 18
- Patients with mucoviscidose in stable condition, i.e. not having presented an acute push of bronchopulmonary attack requiring a antibiothérapie or a hospitalization for treatment of its disease during the 2 previous weeks
- Signed consent
- Volunteers :
- Men or women over 18
- Without respiratory antecedent nor known respiratory pathology
- Signed consent
Who cannot join
- Patients :
- In exclusion period of an other study
- Volunteers :
- In exclusion period of an other study
- Antibiotic treatment and/or anti-inflammatory drug (AINS or corticoids) in the 2 weeks before inclusion in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Secretion Induction of Neutrophil Extracellular Traps (NETs)in Inflammatory and Infectious Environment of Mucoviscidose
The study is defined in 3 stages of in vitro assays :
Phase 1 : Secretion of NETs in response to lung disease and their secretion of factors.
Read more
This is a transversal study in which we compare :
- Producing NETs (DNA and proteases ) by neutrophils purified from sputum and blood of patients
- Producing NETs (DNA and proteases ) by purified neutrophils in the blood of patients and blood of control subjects
Phase 2: Mechanisms of activation of NETs secretory pathways . This phase will identify receptors (TLR ) involved in the secretion of NETs and analyze the involvement of dependent transduction pathways calcium and PKC . It will be performed on control blood neutrophils.
Phase 3: Analysis of cell death ( NETose )
This is a transversal study that will analyze :
the mode of cell death of neutrophils purified blood and sputum of patients and control blood neutrophils by flow cytometry and transmission electron microscopy .
- Conditions
- Cystic Fibrosis
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| T | Control | |
| A | Adult with cystic fibrosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
the DNA concentration secreted into the extracellular environment neutrophil activated
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startMay 2011
- Primary completionMay 2013
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.
- More trials run by University Hospital, ToursThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02564393
- Sponsor's protocol ID
- PHAO09-PD / MucoNETs
- Acronym
- MucoNETs
- Status last verified
- Sep 2015
- First submitted
- 29 Sep 2015
- Last updated
- 30 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secretion Induction of Neutrophil Extracellular Traps (NETs)in Inflammatory and Infectious Environment of Mucoviscidose
- ClinicalTrials.gov ID
- NCT02564393
- Acronym / sponsor ID
- MucoNETs / PHAO09-PD / MucoNETs
- Conditions
- Cystic Fibrosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2013 (actual)
- First posted
- 30 Sep 2015 (estimated)
- 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.
The study is defined in 3 stages of in vitro assays :
Phase 1 : Secretion of NETs in response to lung disease and their secretion of factors.
This is a transversal study in which we compare :
- Producing NETs (DNA and proteases ) by neutrophils purified from sputum and blood of patients
- Producing NETs (DNA and proteases ) by purified neutrophils in the blood of patients and blood of control subjects
Phase 2: Mechanisms of activation of NETs secretory pathways . This phase will identify receptors (TLR ) involved in the secretion of NETs and analyze the involvement of dependent transduction pathways calcium and PKC . It will be performed on control blood neutrophils.
Phase 3: Analysis of cell death ( NETose )
This is a transversal study that will analyze :
the mode of cell death of neutrophils purified blood and sputum of patients and control blood neutrophils by flow cytometry and transmission electron microscopy .
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T | – | –Control |
| A | – | –Adult with cystic fibrosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pathophysiological study comparing a " Cystic fibrosis " group to a control group (adults)
Key inclusion criteria (8 listed)
- Men or women over 18
- Patients with mucoviscidose in stable condition, i.e. not having presented an acute push of bronchopulmonary attack requiring a antibiothérapie or a hospitalization for treatment of its disease during the 2 previous weeks
- Signed consent
- Men or women over 18
- Without respiratory antecedent nor known respiratory pathology
Key exclusion criteria (5 listed)
- In exclusion period of an other study
- In exclusion period of an other study
- Antibiotic treatment and/or anti-inflammatory drug (AINS or corticoids) in the 2 weeks before inclusion in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the DNA concentration secreted into the extracellular environment neutrophil activated
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 University Hospital, Tours 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 8 inclusion and 5 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: finished, as of the sponsor's last update on 30 Sep 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the DNA concentration secreted into the extracellular environment neutrophil activated (time frame: 1 hour). 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 30 Sep 2015.