Evaluation of Biological Variability in Cartilage Specific Biomarkers (Coll2-1, Coll2-1NO2, FIB3-1 and FIB 3-2) in Healthy Volunteers.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Artialis
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •hepatitis B or C
- •Patient who are the subject of a judicial protection measure or under guardianship
Outcomes
Primary Outcomes
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.
Time Frame: Baseline and weeks 2, 16, 52 and 68
Change from baseline will be assess by biomarkers dosage using ELISA (Enzyme Linked ImmunoAssay)
Secondary Outcomes
No secondary outcomes reported