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Cystic Fibrosis Blood Neutrophils (MUCO-PNN)

Primary Purpose

Cystic Fibrosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
1 blood sample
2 blood samples
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Cystic Fibrosis focused on measuring Blood neutrophils, Pseudomonas aeruginosa, Cystic fibrosis, CFTR modulators, respiratory exacerbation, airway chronic infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patient over the age of 18 who is not under legal protection

  • Patients with CF according to the diagnostic criteria of the Cystic Fibrosis Foundation including:

    • 15 patients with severe mutation but not chronically infected with PA and not treated with lumacaftor / ivacaftor
    • 15 patients homozygous phe508del, chronically infected with PA and not treated with lumacaftor / ivacaftor
    • 15 patients homozygous phe508del, chronically infected with PA and treated with lumacaftor / ivacaftor
    • 15 hospitalized patients for respiratory exacerbation
    • 40 patients initiating Ivacaftor-Tezacaftor-Elexacaftor treatment.
  • No change in baseline treatment for 15 days (including antibiotic treatment).
  • Patient affiliated to a social security system
  • Free, informed and written consent, dated and signed by the patient and the investigator, at the latest on the day of inclusion and before any action required by the study.

Exclusion Criteria:

  • Informed consent impossible to obtain
  • Involvement in an interventional research protocol in the previous 3 months if exclusion directive was given in this protocol.

Sites / Locations

  • Cochin hospital, AP-HPRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Stable state

Starting Ivacaftor-Tezacaftor-Elexacaftor

Exacerbation

Arm Description

45 adult cystic fibrosis patients followed in the respiratory medicine department of Cochin hospital, paris, France: With severe cftr mutations With or without PA chronic infection Treated or not with Ivacaftor-Lumacaftor

40 adult cystic fibrosis patients followed in the respiratory medicine department of Cochin hospital, paris, France: With at least one severe cftr mutation With or without PA chronic infection Initiating Ivacaftor-Tezacaftor-Elexacaftor

15 adult cystic fibrosis patients followed in the respiratory medicine department of Cochin hospital, paris, France and hospitalized for respiratory exacerbation

Outcomes

Primary Outcome Measures

Quantification of blood low density neutrophils in cystic fibrosis (CF)
Quantitative flow cytometric evaluation of neutrophil membrane markers that differ according to whether they are : mature neutrophils : CD16high, CD15high, CD33high, CD10high or Low density neutrophils (LDG) : CD16low, CD15neg, CD33 neg, CD10 neg. Comparison of neutrophil membrane markers profile in CF patients versus control blood-donors.
Transcriptomic analysis of blood neutrophils in cystic fibrosis (CF)
Transcriptomic analysis of blood neutrophil proinflammatory or immunomodulatory potential. Comparison of transcriptomic blood neutrophil profile in CF patients versus control blood-donors.
Effector function analysis of blood neutrophils in CF.
Comparison of effector function analysis of blood neutrophils of CF patients versus control blood-donors.
Phagocytosis potential of blood neutrophils in CF.
Comparison of phagocytosis potential of blood neutrophils of CF patients versus control blood-donors.
Survival/apoptosis balance analysis in CF
Survival / apoptosis balance analysis : (PCNA localization) in CF patients blood neutrophils versus control blood-donors.

Secondary Outcome Measures

Quantification of blood low density neutrophils in CF vs other chronic inflammatory disorders.
Quantitative flow cytometric evaluation of neutrophil membrane markers that differ according to whether they are: mature neutrophils : CD16high, CD15high, CD33high, CD10high Low density neutrophils (LDG) : CD16low, CD15neg, CD33 neg, CD10 neg. Comparison of neutrophil membrane markers profile in CF patients versus patients with other chronic inflammatory disease (eg. Rheumatoid arthritis, inflammatory bowel disease).
Quantification of blood low density neutrophils in CF according to different clinical situations.
Quantitative flow cytometric evaluation of neutrophil membrane markers. At stable state: presence or absence of airway chronic infection with PA whether or not patients are treated Ivacaftor-Lumacaftor At beginning of exacerbation or after antibiotic treatment. Before or after Ivacaftor-Tezacaftor-Elexacaftor treatment
Transcriptomic analysis of blood neutrophils in CF according to different clinical situations.
Transcriptomic analysis of blood neutrophil proinflammatory or immunomodulatory potential. At stable state: presence or absence of airway chronic infection with PA whether or not patients are treated Ivacaftor-Lumacaftor At beginning of exacerbation or after antibiotic treatment. Before or after Ivacaftor-Tezacaftor-Elexacaftor treatment
Effector function analysis of blood neutrophils in CF according to different clinical situations.
Effector function analysis of blood neutrophils: At stable state: presence or absence of airway chronic infection with PA whether or not patients are treated Ivacaftor-Lumacaftor At beginning of exacerbation or after antibiotic treatment. Before or after Ivacaftor-Tezacaftor-Elexacaftor treatment
Phagocytosis potential of blood neutrophils in CF according to different clinical situations.
Phagocytosis potential analysis of blood neutrophils in CF: At stable state: presence or absence of airway chronic infection with PA whether or not patients are treated Ivacaftor-Lumacaftor At beginning of exacerbation or after antibiotic treatment. Before or after Ivacaftor-Tezacaftor-Elexacaftor treatment
Survival/apoptosis balance analysis in CF according to different clinical situations.
Survival / apoptosis balance analysis (PCNA localization): At stable state: presence or absence of airway chronic infection with PA whether or not patients are treated Ivacaftor-Lumacaftor At beginning of exacerbation or after antibiotic treatment. Before or after Ivacaftor-Tezacaftor-Elexacaftor treatment.

Full Information

First Posted
January 17, 2019
Last Updated
September 18, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT04970225
Brief Title
Cystic Fibrosis Blood Neutrophils
Acronym
MUCO-PNN
Official Title
Functional and Phenotypic Characteristics of Blood Neutrophils in Cystic Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 8, 2021 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

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 purpose of this prospective study is to analyze function and phenotype of blood neutrophils in cystic fibrosis patients and the impact of Pseudomonas aeruginosa chronic infection, treatment with CFTR modulators and acute exacerbation on blood neutrophils phenotype and function.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Blood neutrophils, Pseudomonas aeruginosa, Cystic fibrosis, CFTR modulators, respiratory exacerbation, airway chronic infection

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stable state
Arm Type
Experimental
Arm Description
45 adult cystic fibrosis patients followed in the respiratory medicine department of Cochin hospital, paris, France: With severe cftr mutations With or without PA chronic infection Treated or not with Ivacaftor-Lumacaftor
Arm Title
Starting Ivacaftor-Tezacaftor-Elexacaftor
Arm Type
Experimental
Arm Description
40 adult cystic fibrosis patients followed in the respiratory medicine department of Cochin hospital, paris, France: With at least one severe cftr mutation With or without PA chronic infection Initiating Ivacaftor-Tezacaftor-Elexacaftor
Arm Title
Exacerbation
Arm Type
Experimental
Arm Description
15 adult cystic fibrosis patients followed in the respiratory medicine department of Cochin hospital, paris, France and hospitalized for respiratory exacerbation
Intervention Type
Other
Intervention Name(s)
1 blood sample
Intervention Description
4 tubes of 7 ml per sample (a single sample)
Intervention Type
Other
Intervention Name(s)
2 blood samples
Intervention Description
4 tubes of 7 ml per sample / 2 samples : before / after antibiotic treatment
Primary Outcome Measure Information:
Title
Quantification of blood low density neutrophils in cystic fibrosis (CF)
Description
Quantitative flow cytometric evaluation of neutrophil membrane markers that differ according to whether they are : mature neutrophils : CD16high, CD15high, CD33high, CD10high or Low density neutrophils (LDG) : CD16low, CD15neg, CD33 neg, CD10 neg. Comparison of neutrophil membrane markers profile in CF patients versus control blood-donors.
Time Frame
Through study completion, an average of 1 year
Title
Transcriptomic analysis of blood neutrophils in cystic fibrosis (CF)
Description
Transcriptomic analysis of blood neutrophil proinflammatory or immunomodulatory potential. Comparison of transcriptomic blood neutrophil profile in CF patients versus control blood-donors.
Time Frame
Through study completion, an average of 1 year
Title
Effector function analysis of blood neutrophils in CF.
Description
Comparison of effector function analysis of blood neutrophils of CF patients versus control blood-donors.
Time Frame
Through study completion, an average of 1 year
Title
Phagocytosis potential of blood neutrophils in CF.
Description
Comparison of phagocytosis potential of blood neutrophils of CF patients versus control blood-donors.
Time Frame
Through study completion, an average of 1 year
Title
Survival/apoptosis balance analysis in CF
Description
Survival / apoptosis balance analysis : (PCNA localization) in CF patients blood neutrophils versus control blood-donors.
Time Frame
Through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
Quantification of blood low density neutrophils in CF vs other chronic inflammatory disorders.
Description
Quantitative flow cytometric evaluation of neutrophil membrane markers that differ according to whether they are: mature neutrophils : CD16high, CD15high, CD33high, CD10high Low density neutrophils (LDG) : CD16low, CD15neg, CD33 neg, CD10 neg. Comparison of neutrophil membrane markers profile in CF patients versus patients with other chronic inflammatory disease (eg. Rheumatoid arthritis, inflammatory bowel disease).
Time Frame
Through study completion, an average of 1 year
Title
Quantification of blood low density neutrophils in CF according to different clinical situations.
Description
Quantitative flow cytometric evaluation of neutrophil membrane markers. At stable state: presence or absence of airway chronic infection with PA whether or not patients are treated Ivacaftor-Lumacaftor At beginning of exacerbation or after antibiotic treatment. Before or after Ivacaftor-Tezacaftor-Elexacaftor treatment
Time Frame
Through study completion, an average of 1 year
Title
Transcriptomic analysis of blood neutrophils in CF according to different clinical situations.
Description
Transcriptomic analysis of blood neutrophil proinflammatory or immunomodulatory potential. At stable state: presence or absence of airway chronic infection with PA whether or not patients are treated Ivacaftor-Lumacaftor At beginning of exacerbation or after antibiotic treatment. Before or after Ivacaftor-Tezacaftor-Elexacaftor treatment
Time Frame
Through study completion, an average of 1 year
Title
Effector function analysis of blood neutrophils in CF according to different clinical situations.
Description
Effector function analysis of blood neutrophils: At stable state: presence or absence of airway chronic infection with PA whether or not patients are treated Ivacaftor-Lumacaftor At beginning of exacerbation or after antibiotic treatment. Before or after Ivacaftor-Tezacaftor-Elexacaftor treatment
Time Frame
Through study completion, an average of 1 year
Title
Phagocytosis potential of blood neutrophils in CF according to different clinical situations.
Description
Phagocytosis potential analysis of blood neutrophils in CF: At stable state: presence or absence of airway chronic infection with PA whether or not patients are treated Ivacaftor-Lumacaftor At beginning of exacerbation or after antibiotic treatment. Before or after Ivacaftor-Tezacaftor-Elexacaftor treatment
Time Frame
Through study completion, an average of 1 year
Title
Survival/apoptosis balance analysis in CF according to different clinical situations.
Description
Survival / apoptosis balance analysis (PCNA localization): At stable state: presence or absence of airway chronic infection with PA whether or not patients are treated Ivacaftor-Lumacaftor At beginning of exacerbation or after antibiotic treatment. Before or after Ivacaftor-Tezacaftor-Elexacaftor treatment.
Time Frame
Through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient over the age of 18 who is not under legal protection Patients with CF according to the diagnostic criteria of the Cystic Fibrosis Foundation including: 15 patients with severe mutation but not chronically infected with PA and not treated with lumacaftor / ivacaftor 15 patients homozygous phe508del, chronically infected with PA and not treated with lumacaftor / ivacaftor 15 patients homozygous phe508del, chronically infected with PA and treated with lumacaftor / ivacaftor 15 hospitalized patients for respiratory exacerbation 40 patients initiating Ivacaftor-Tezacaftor-Elexacaftor treatment. No change in baseline treatment for 15 days (including antibiotic treatment). Patient affiliated to a social security system Free, informed and written consent, dated and signed by the patient and the investigator, at the latest on the day of inclusion and before any action required by the study. Exclusion Criteria: Informed consent impossible to obtain Involvement in an interventional research protocol in the previous 3 months if exclusion directive was given in this protocol.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pierre-Régis BURGEL, MD PHD
Phone
+33 1 58 41 23 67
Email
pierre-regis.burgel@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Marie BENHAMMANI-GODARD
Phone
+33 1 58 41 11 90
Email
marie.godard@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre-Régis BURGEL, MD PHD
Organizational Affiliation
APHP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cochin hospital, AP-HP
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre-Régis BURGEL
Phone
àà 33 1 58 41 23 67
Email
pierre-regis.burgel@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No
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