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Biological Variability in Cartilage Specific Biomarkers in Healthy Volunteers.

Evaluation of Biological Variability in Cartilage Specific Biomarkers (Coll2-1, Coll2-1NO2, FIB3-1 and FIB 3-2) in Healthy Volunteers.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02348944
Acronym
COVAR
Enrollment
15
Registered
2015-01-28
Start date
2013-08-31
Completion date
2014-12-31
Last updated
2015-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Effects of; Serum, Urine Marking

Keywords

Biological markers, Cartilage

Brief summary

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

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.

Interventions

OTHERserum 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.

Sponsors

Artialis
Lead SponsorINDUSTRY

Study design

Observational model
COHORT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Variation of serum and urine sample between baseline, weeks 2, 16, 52 and 68 to assess intra-individual biological variability of cartilage-specific biomarkers Coll2-1/Coll2-1NO2 / FIB3-1 and FIB3-2.Baseline and weeks 2, 16, 52 and 68Change from baseline will be assess by biomarkers dosage using ELISA (Enzyme Linked ImmunoAssay)

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026