Biological Variability in Cartilage Specific Biomarkers in Healthy Volunteers.

Completed

• Conditions: Urine Marking; Effects of; Serum
• Interventions: Other: serum and urine sample

• Registration Number: NCT02348944
• Lead Sponsor: Artialis

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.

Study Timeline

• Study Start: 2013-08
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-01
• Study First Submitted: 2015-01-19
• Study First Submitted QC: 2015-01-23
• Last Update Submitted: 2015-01-23
• Study First Posted: 2015-01-28
• Last Update Posted: 2015-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
15 healthy volunteers	serum and urine sample	Other: serum and urine sample

Primary Outcome Measures

Name	Time	Method
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 68	Change from baseline will be assess by biomarkers dosage using ELISA (Enzyme Linked ImmunoAssay)

Trial Locations

Locations (1)

ATC SA, Unité de pharmacologie clinique, CHU Sart Tilman; 🇧🇪 Liege, Belgium