RHEology of the Pulmonary MUcus | NCT04687319

Studies
RHEology of the Pulmonary MUcus

NCT04687319

Sponsor

University Hospital, Grenoble

Status

Unknown status

Last Update Posted

Jan 19, 2021Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Bronchial Mucus in COPD and Cystic Fibrosis

Interventions

bronchial mucus collection

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2020-A02367-32	Other Identifier	ID RCB

Status Module

Record Verification Date

Dec 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2021Estimated

Primary Completion Date

Jan 2023Estimated

Completion Date

Dec 2023Estimated

First Submitted Date

Dec 7, 2020

First Submission Date that Met QC Criteria

Dec 22, 2020

First Posted Date

Dec 29, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2021

Last Update Posted Date

Jan 19, 2021Actual

Name	Class
University Grenoble Alps	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
bronchial mucus collection	Biological	mucus resulting from respiratory physiotherapy sessions for patients with cystic fibrosis or COPD, bronchial aspirations resulting from the bronchial fibroscopy programme

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reproducibility of the rheology parameters studied	Establish operating protocols for obtaining reliable rheological measurements with a view to using them as biomarkers	Day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Non-Probability Sample

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003550	Cystic Fibrosis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided