Big Data Analysis of the Use of bIomarkers Concentration (rUBIDIuM)

August 18, 2017 updated by: Christophe Meune, MD-PhD, Hospital Avicenne

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

585745

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
      • Bobigny, France, 93000
        • Avicenne Hospital

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • All adult patients >20 that came to a participating lab (Biorance Laboratoires Réunis) during the study period for biological measurement

Exclusion Criteria:

  • DNA analysis, HIV test

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
biomarker dosage prescription
Time Frame: August 2017
physicians' use and eventually misuse of biomarkers dosage
August 2017

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Biomarkers dosage numbers
Time Frame: August 2017
Biomarkers dosage numbers before and after new treatments, released of guidelines, new tests...
August 2017
Biomarkers in geriatric patients
Time Frame: August 2017
biomarkers dosages and concentration in elderly/very elderly patients
August 2017
Population's characteristics
Time Frame: August 2017
physicians' use and eventually misuse of biomarkers dosage
August 2017

Collaborators and Investigators

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

Sponsor

Hospital Avicenne

Collaborators

Roche Diagnostics
ProBayes
Biorance Laboratoires Réunis

Investigators

  • Principal Investigator: Christophe Meune, MD PhD, Avicenne Hospital

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)

February 17, 2010

Primary Completion (Actual)

August 30, 2015

Study Completion (Actual)

September 10, 2015

Study Registration Dates

First Submitted

August 16, 2017

First Submitted That Met QC Criteria

August 16, 2017

First Posted (Actual)

August 18, 2017

Study Record Updates

Last Update Posted (Actual)

August 22, 2017

Last Update Submitted That Met QC Criteria

August 18, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2017-003438-10

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only aggregated data are available

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.

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