NCT02880111

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2016

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

October 18, 2022

Status Verified

August 1, 2020

Enrollment Period

5.9 years

First QC Date

August 23, 2016

Last Update Submit

October 14, 2022

Conditions

Malignant Brain Tumor

Keywords

Malignant Brain Tumorpatient sputum

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • measure MUC5B by Elisa

    at 1 months

Study Arms (2)

group 1

CF patients with Pseudomonas aeruginosa chronic colonization.

group 2

CF patients without a Pseudomonas aeruginosa chronic colonization.

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Cardiac insufficiency
  • Anti-inflammatory drugs on going
  • Oral corticosteroid therapy
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Jeanne de Flandre - CHRU de Lille

Lille, France

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Dominique Turck, MD, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2016

First Posted

August 26, 2016

Study Start

March 23, 2016

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

October 18, 2022

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)