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

October 14, 2022 updated by: University Hospital, Lille

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

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.

Study Overview

Status

Terminated

Conditions

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.

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France
        • Hôpital Jeanne de Flandre - CHRU de Lille

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

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

CF Patients with or without Pseudomonas aeruginosa chronic colonization status aged 6 years.

Description

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...

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

Cohorts and Interventions

Group / Cohort
group 1
CF patients with Pseudomonas aeruginosa chronic colonization.
group 2
CF patients without a Pseudomonas aeruginosa chronic colonization.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Collaborators

Ministry of Health, France

Investigators

  • Principal Investigator: Dominique TURCK, MD, PhD, University Hospital, Lille

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 (Actual)

March 23, 2016

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

August 23, 2016

First Submitted That Met QC Criteria

August 25, 2016

First Posted (Estimate)

August 26, 2016

Study Record Updates

Last Update Posted (Actual)

October 18, 2022

Last Update Submitted That Met QC Criteria

October 14, 2022

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012_44
  • 2014-A00259-38 (Other Identifier: ID-RCB number, ANSM)
  • PHRCI-2012 (Other Identifier: PHRC number, DGOS)

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.

Clinical Trials on Malignant Brain Tumor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe