Biological Variability in Cartilage Specific Biomarkers in Healthy Volunteers.

Urine Marking Clinical Trial

— COVAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02348944
• Other study ID #: COVAR
• Status: Completed
• Phase: N/A
• First received: January 19, 2015
• Last updated: January 23, 2015
• Start date: August 2013
• Est. completion date: December 2014

Study information

• Verified date: January 2015
• Source: Artialis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Effects of; Serum
• Urine Marking

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Belgium	ATC SA, Unité de pharmacologie clinique, CHU Sart Tilman	Liege

Sponsors (1)

Lead Sponsor	Collaborator
Artialis

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline will be assess by biomarkers dosage using ELISA (Enzyme Linked ImmunoAssay)	Baseline and weeks 2, 16, 52 and 68	No