Biological Variability in Cartilage Specific Biomarkers in Healthy Volunteers.

NCT ID: NCT02348944

Last Updated: 2015-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-12-31

Brief Summary

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The purposes of the study are to assess intra individual biological variability of serum and urinary cartilage specific biomarkers and define the best standardized conditions for blood and urine sampling in the frame of biomarkers dosage.

Detailed Description

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To assess intra individual biological variability of serum and urinary cartilage specific biomarkers and define the best standardized conditions for blood and urine sampling in the frame of biomarkers dosage. Variation factors assessed are:

* Fasting condition
* Sampling time
* Sampling season
* Physical activity
* Duration and temperature of total blood treatment
* Type of blood collection tube.

Conditions

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Effects of; Serum Urine Marking

Study Design

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Observational Model Type

COHORT

Study Groups

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15 healthy volunteers

Other: serum and urine sample

serum and urine sample

Intervention Type OTHER

Serum and urine samples will be collected at baseline, weeks2, 16, 52 and 68 to assess intra-individual biological variability of cartilage-specific biomarkers Coll2-1/Coll2-1NO2 / FIB3-1 and FIB3-2.

Interventions

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serum and urine sample

Serum and urine samples will be collected at baseline, weeks2, 16, 52 and 68 to assess intra-individual biological variability of cartilage-specific biomarkers Coll2-1/Coll2-1NO2 / FIB3-1 and FIB3-2.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male or female, aged above 18 years.
* Sign an informed consent after being informed
* Able to follow the instructions of the study

Exclusion Criteria

* Serious associated diseases:

* Severe liver disease
* Renal failure
* HIV
* hepatitis B or C
* Patient who are the subject of a judicial protection measure or under guardianship
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Artialis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bernard Jandrain, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Pharmacology Unit, ATC sa, Belgium

Locations

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ATC SA, Unité de pharmacologie clinique, CHU Sart Tilman

Liège, Liege, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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COVAR

Identifier Type: -

Identifier Source: org_study_id

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