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Completed

NCT Number: NCT02348944

Biological Variability in Cartilage Specific Biomarkers in Healthy Volunteers.

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.

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Key information

Conditions

Effects of; Serum Urine Marking

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

ATC SA, Unité de pharmacologie clinique, CHU Sart Tilman

Liège, Liege, 4000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

serum and urine sample

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.

Primary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Artialis

Industry

Registry information

Official study title

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

Acronym: COVAR

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jan 28, 2015
Registry last updated
Jan 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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