- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04687319
RHEology of the Pulmonary MUcus (RHEMU)
January 14, 2021 updated by: University Hospital, Grenoble
Protocol for the Collection of Lung Mucus Samples From Care for a Rheology Research Programme
Patients for whom bronchial mucus collection has been performed as part of the treatment will be offered the opportunity to participate in the study.
- A rheology measurement will be carried out shortly after the collection of fresh bronchial mucus samples.
- Another part will be done on frozen bronchial mucus samples
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
100
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patient consulting or hospitalised in the pneumology department and for whom an emission of bronchial mucus is planned as part of the treatment
Description
Inclusion Criteria:
- Male or female over 18 years of age.
- Patient consulting or hospitalised in the pneumology department and for whom an emission of bronchial mucus is planned as part of the treatment (mucus from respiratory physiotherapy sessions for patients with cystic fibrosis or COPD, bronchial aspirations from the bronchial fibroscopy programme).
Exclusion Criteria:
- Patient being opposed to the use of his mucus samples and data for this research.
- Patient protected by law (guardianship or curatorship), subject deprived of liberty
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Reproducibility of the rheology parameters studied
Time Frame: Day 1
|
Establish operating protocols for obtaining reliable rheological measurements with a view to using them as biomarkers
|
Day 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
January 1, 2021
Primary Completion (Anticipated)
January 1, 2023
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
December 7, 2020
First Submitted That Met QC Criteria
December 22, 2020
First Posted (Actual)
December 29, 2020
Study Record Updates
Last Update Posted (Actual)
January 19, 2021
Last Update Submitted That Met QC Criteria
January 14, 2021
Last Verified
December 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38RC20.298
- 2020-A02367-32 (Other Identifier: ID RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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