Biological MarkersrUBIDIuMNCT03254472
Big Data Analysis of the Use of bIomarkers Concentration
An observational study of Biological Markers and Inappropriate Prescribing, run by Hospital Avicenne at 1 site in France.
Trial summary
The investigators conducted a retrospective analysis of all measured concentrations performed in a large subset of laboratories located in the French Brittany from February 2010 the 17th to August 2015 the 30th, in adults over 20 years old. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Biological Markers, Inappropriate Prescribing
- What is being tested?
- Measured concentrations of biomarkers
- How many people
- 585,745 participants
- Where
- 1 siteFrance
- Study dates
- 17 Feb 2010to 10 Sep 2015
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cohort that included all analyses performed in a large subset of laboratories located in the French Brittany from February 2010 the 17th to August 2015 the 30th. The extract data corresponded to 74,502,510 analyses performed in 585,745 distinct adult patients >20y
Who may be able to join
- All adult patients >20 that came to a participating lab (Biorance Laboratoires Réunis) during the study period for biological measurement
Who cannot join
- DNA analysis, HIV test
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Defining Use and Misuse of BIoMarkers Dosage and Trends in Observed Concentration Over Time: a BIg Data Analysis
The investigators conducted a retrospective analysis of all measured concentrations performed in a large subset of laboratories located in the French Brittany from February 2010 the 17th to August 2015 the 30th, in adults over 20 years old.
The investigators are aimed at studying physicians' use and eventually misuse of biomarkers dosage and the characteristics of a broad population based on some biomarkers concentrations.
Read the detailed description
The rUBIDIuM study is a retrospective analysis that included all tests (but not including DNA analysis or HIV tests) performed in a large subset of laboratories located in the French Brittany from February 2010 the 17th to August 2015 the 30th. The area of study covers most of the Ille-et-Vilaine and a part of the Côtes d'Armor department in Brittany. The respective surface of these departments is 6775 and 6878 km2. All labs belong to the Biorance Laboratory group (consortium of 33 labs, Biorance Laboratoires Réunis) and are equipped with Roche Diagnostics instruments (Elecsys2010® analyzer, Roche diagnostics, Meylan, France).
The main objectives are to study physicians' use and eventually misuse of biomarkers dosage and the characteristics of this broad population based on some biomarkers concentrations.
For all adult patients >20y that came to a participating lab during the study period, the investigators collected the following information: demographics data, data about the prescription (date of order, list of analysis recommended, the date of blood collection and analysis), about the prescribers and the results of the analyses. After a de-identifying process, data were aggregated.
the initial analyses will 1) examine the biological tests (number, types…) ordered in a large cohort of patients, in the total population and the subgroups based on gender, age, time period, kind of lab and physicians' specialty, 2) examine the results/concentration of the analyses: blood chemistry, creatinin concentration, cardiac enzymes, natriuretic peptides, INR, lipid profile, hemogram…
- Conditions
- Biological Markers, Inappropriate Prescribing
- Being tested
- Measured concentrations of biomarkers
- Keywords
- Biological markers, Professional practice, Big data analysis, Measured concentrations, Cardiac markers, Troponin, NTproBNP, Creatinin, INR, Hemogram, Lipid profile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measured concentrations of biomarkersDiagnostic test
What is being measured
The primary outcome is the main question the study is designed to answer.
biomarker dosage prescription
physicians' use and eventually misuse of biomarkers dosage
Measured: August 2017
Secondary outcomes (3)
Biomarkers dosage numbers
Biomarkers dosage numbers before and after new treatments, released of guidelines, new tests...
Measured: August 2017
Biomarkers in geriatric patients
biomarkers dosages and concentration in elderly/very elderly patients
Measured: August 2017
Population's characteristics
physicians' use and eventually misuse of biomarkers dosage
Measured: August 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start17 Feb 2010
- Primary completion30 Aug 2015
- Study completion10 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biological MarkersStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Retrospective
- Enrolment
- 585,745 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Avicenne
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Diagnostics GmbH, ProBayes, Biorance Laboratoires Réunis
- Responsible party
- Principal investigator, Christophe Meune, MD-PhD, Hospital Avicenne
- Investigators
- Christophe Meune, MD PhD, Principal investigator, Avicenne Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254472
- Sponsor's protocol ID
- 2017-003438-10
- Other IDs
- 2017
- Acronym
- rUBIDIuM
- Status last verified
- Aug 2017
- First submitted
- 16 Aug 2017
- Last updated
- 22 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only aggregated data are available
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining Use and Misuse of BIoMarkers Dosage and Trends in Observed Concentration Over Time: a BIg Data Analysis
- ClinicalTrials.gov ID
- NCT03254472
- Acronym / sponsor ID
- rUBIDIuM / 2017-003438-10
- Conditions
- Biological Markers, Inappropriate Prescribing
- Keywords
- Biological markers, Professional practice, Big data analysis, Measured concentrations, Cardiac markers, Troponin, NTproBNP, Creatinin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 585,745 participants (actual)
- Lead sponsor
- Hospital AvicenneUniversity, hospital or other
- Collaborators
- Roche Diagnostics GmbH, ProBayes, Biorance Laboratoires Réunis
- Study start
- 17 Feb 2010 (actual)
- Primary completion
- 30 Aug 2015 (actual)
- Study completion
- 10 Sep 2015 (actual)
- First posted
- 18 Aug 2017 (actual)
- 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.
The investigators conducted a retrospective analysis of all measured concentrations performed in a large subset of laboratories located in the French Brittany from February 2010 the 17th to August 2015 the 30th, in adults over 20 years old.
The investigators are aimed at studying physicians' use and eventually misuse of biomarkers dosage and the characteristics of a broad population based on some biomarkers concentrations.
Detailed description
The rUBIDIuM study is a retrospective analysis that included all tests (but not including DNA analysis or HIV tests) performed in a large subset of laboratories located in the French Brittany from February 2010 the 17th to August 2015 the 30th. The area of study covers most of the Ille-et-Vilaine and a part of the Côtes d'Armor department in Brittany. The respective surface of these departments is 6775 and 6878 km2. All labs belong to the Biorance Laboratory group (consortium of 33 labs, Biorance Laboratoires Réunis) and are equipped with Roche Diagnostics instruments (Elecsys2010® analyzer, Roche diagnostics, Meylan, France).
The main objectives are to study physicians' use and eventually misuse of biomarkers dosage and the characteristics of this broad population based on some biomarkers concentrations.
For all adult patients >20y that came to a participating lab during the study period, the investigators collected the following information: demographics data, data about the prescription (date of order, list of analysis recommended, the date of blood collection and analysis), about the prescribers and the results of the analyses. After a de-identifying process, data were aggregated.
the initial analyses will 1) examine the biological tests (number, types…) ordered in a large cohort of patients, in the total population and the subgroups based on gender, age, time period, kind of lab and physicians' specialty, 2) examine the results/concentration of the analyses: blood chemistry, creatinin concentration, cardiac enzymes, natriuretic peptides, INR, lipid profile, hemogram…
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cohort that included all analyses performed in a large subset of laboratories located in the French Brittany from February 2010 the 17th to August 2015 the 30th. The extract data corresponded to 74,502,510 analyses performed in 585,745 distinct adult patients >20y
Key inclusion criteria (1 listed)
- All adult patients >20 that came to a participating lab (Biorance Laboratoires Réunis) during the study period for biological measurement
Key exclusion criteria (1 listed)
- DNA analysis, HIV test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measured concentrations of biomarkers | Diagnostic test | – |
Primary outcome
biomarker dosage prescription
Time frame: August 2017
physicians' use and eventually misuse of biomarkers dosage
3 secondary outcomes
Biomarkers dosage numbers
Time frame: August 2017
Biomarkers in geriatric patients
Time frame: August 2017
Population's characteristics
Time frame: August 2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2017.
- Individual participant dataSharing planned: No. Only aggregated data are available
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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.
Christophe Meune, MD PhD principal investigator
Avicenne Hospital
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 Biological Markers and Inappropriate Prescribing, run by Hospital Avicenne 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 22 Aug 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
biomarker dosage prescription (time frame: August 2017). 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 22 Aug 2017.