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

Malignant Brain Tumor Clinical Trial

— DMBT1  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02880111
• Other study ID #: 2012_44
• Secondary ID: 2014-A00259-38PH
• Status: Terminated
• Start date: March 23, 2016
• Est. completion date: March 2022

Study information

• Verified date: August 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 2022
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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...

Related Conditions & MeSH terms

• Brain Neoplasms
• Malignant Brain Tumor

Locations

Country	Name	City	State
France	Hôpital Jeanne de Flandre - CHRU de Lille	Lille

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Lille	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measure glycoprotein-like DMBT1 by Elisa	DMBT1 in mg DMBT1 / mg of total protein measured by BCA (BiCinchoninic acid Assay) present in each sputum	at 1 months
Secondary	measure MUC5B by Elisa	MUCB in mg / mg of total protein measured by BCA present in each sputum	at 1 months