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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Avicenne

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Roche Diagnostics
ProBayes
Biorance Laboratoires Réunis

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 17, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 30, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 10, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 18, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 22, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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