Malignant Brain TumorDMBT1NCT02880111
Rates DMBT1 ( Glycoprotein) in Sputum of CF Patients With Pseudomonas Aeruginosa
An observational study of Malignant Brain Tumor, run by University Hospital, Lille at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Malignant Brain Tumor
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 23 Mar 2016to Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: CF Patients with or without Pseudomonas aeruginosa chronic colonization status aged 6 years.
Who may be able to join
- CF patient 6 years
- Availability of sputum
- Signed Informed consent
Who cannot join
- 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
Show all 10Show fewer
- 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...
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Malignant Brain Tumor
- Keywords
- Malignant Brain Tumor, patient sputum
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| group 1 | CF patients with Pseudomonas aeruginosa chronic colonization. | |
| group 2 | CF patients without a Pseudomonas aeruginosa chronic colonization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure glycoprotein-like DMBT1 by Elisa
DMBT1 in mg DMBT1 / mg of total protein measured by BCA (BiCinchoninic acid Assay) present in each sputum
Measured: at 1 months
Secondary outcomes (1)
measure MUC5B by Elisa
MUCB in mg / mg of total protein measured by BCA present in each sputum
Measured: at 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study start23 Mar 2016
- Primary completionMar 2022
- Study completionMar 2022
Why it stopped: only one patient was included
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Brain TumorStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Dominique Turck, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880111
- Sponsor's protocol ID
- 2012_44
- Other IDs
- 2014-A00259-38, PHRCI-2012
- Acronym
- DMBT1
- Status last verified
- Aug 2020
- First submitted
- 23 Aug 2016
- Last updated
- 18 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Rates DMBT1 ( Glycoprotein) in Sputum of CF Patients Colonized Patients Between Chronic and Non-chronic Patients Colonized With Pseudomonas Aeruginosa
- ClinicalTrials.gov ID
- NCT02880111
- Acronym / sponsor ID
- DMBT1 / 2012_44
- Conditions
- Malignant Brain Tumor
- Keywords
- Malignant Brain Tumor, patient sputum
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: only one patient was included
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 23 Mar 2016 (actual)
- Primary completion
- Mar 2022 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 26 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group 1 | – | –CF patients with Pseudomonas aeruginosa chronic colonization. |
| group 2 | – | –CF patients without a Pseudomonas aeruginosa chronic colonization. |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- CF Patients with or without Pseudomonas aeruginosa chronic colonization status aged 6 years.
Key inclusion criteria (3 listed)
- CF patient 6 years
- Availability of sputum
- Signed Informed consent
Key exclusion criteria (10 listed)
- Cardiac insufficiency
- Anti-inflammatory drugs on going
- Oral corticosteroid therapy
- Inhaled corticosteroids during the two weeks before inclusion,
- Patient awaiting lung transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
measure MUC5B by Elisa
Time frame: at 1 months
Results and safety
The study was stopped early (reason given: only one patient was included). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominique Turck, MD, PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Brain Tumor, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: only one patient was included). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure glycoprotein-like DMBT1 by Elisa (time frame: at 1 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2022.