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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03254472
Other study ID # 2017-003438-10
Secondary ID
Status Completed
Phase N/A
First received August 16, 2017
Last updated August 18, 2017
Start date February 17, 2010
Est. completion date September 10, 2015

Study information

Verified date August 2017
Source Hospital Avicenne
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.

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.


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…


Recruitment information / eligibility

Status Completed
Enrollment 585745
Est. completion date September 10, 2015
Est. primary completion date August 30, 2015
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Measured concentrations of biomarkers


Locations

Country Name City State
France Avicenne Hospital Bobigny

Sponsors (4)

Lead Sponsor Collaborator
Hospital Avicenne Biorance Laboratoires Réunis, ProBayes, Roche Diagnostics

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary biomarker dosage prescription physicians' use and eventually misuse of biomarkers dosage August 2017
Secondary Biomarkers dosage numbers Biomarkers dosage numbers before and after new treatments, released of guidelines, new tests... August 2017
Secondary Biomarkers in geriatric patients biomarkers dosages and concentration in elderly/very elderly patients August 2017
Secondary Population's characteristics physicians' use and eventually misuse of biomarkers dosage August 2017
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