Rates DMBT1 ( Glycoprotein) in Sputum of CF Patients With Pseudomonas Aeruginosa

Comparison of Rates DMBT1 ( Glycoprotein) in Sputum of CF Patients Colonized Patients Between Chronic and Non-chronic Patients Colonized With Pseudomonas Aeruginosa

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02880111

Acronym

DMBT1

Enrollment

Registered

2016-08-26

Start date

2016-03-23

Completion date

2022-03-31

Last updated

2022-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malignant Brain Tumor

Keywords

Malignant Brain Tumor, patient sputum

Brief summary

Rates of DMBT1 (Glycoprotein like) in Sputum of CF Patients with or without may be different according to their Pseudomonas Aeruginosa chronic colonization status. The aim of this study is to compare rates of DMBT1 (Glycoprotein like) in Sputum of CF patients with or without a Pseudomonas Aeruginosa chronic colonization.

Detailed description

Rates of DMBT1 (Deleted in Malignant Brain Tumor 1) will be compared between 2 groups of 30 CF patients : group 1 : with Pseudomonas Aeruginosa chronic colonization and group 2 30 CF patients without Pseudomonas Aeruginosa chronic colonization.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

Healthy volunteers

Inclusion criteria

* CF patient 6 years * Availability of sputum * Signed Informed consent

Exclusion criteria

* Cardiac insufficiency * Anti-inflammatory drugs on going * Oral corticosteroid therapy * Inhaled corticosteroids during the two weeks before inclusion, * Patient awaiting lung transplantation * Patient with a past history of heart/lung transplantation * Patient with a sputum examination positive for : atypical mycobacteria, Burkholderia cepacia, Stenotrophomonas maltophilia, * Patient chronically colonized with multiresistant Pseudomonas aeruginosa * Orkambi© or Kalydeco© therapy * Change of the CF treatment during the last 4 weeks +/- 2 days before inclusion : corticosteroid, pancreatic extracts, antisecretory drugs...

Design outcomes

Primary

Measure	Time frame	Description
measure glycoprotein-like DMBT1 by Elisa	at 1 months	DMBT1 in mg DMBT1 / mg of total protein measured by BCA (BiCinchoninic acid Assay) present in each sputum

Secondary

Measure	Time frame	Description
measure MUC5B by Elisa	at 1 months	MUCB in mg / mg of total protein measured by BCA present in each sputum

Countries

France

Outcome results