NCT02348944

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 28, 2015

Completed
Last Updated

January 28, 2015

Status Verified

January 1, 2015

Enrollment Period

1.3 years

First QC Date

January 19, 2015

Last Update Submit

January 23, 2015

Conditions

Effects of; SerumUrine Marking

Keywords

Biological markersCartilage

Outcome Measures

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.

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

    Baseline and weeks 2, 16, 52 and 68

Study Arms (1)

15 healthy volunteers

Other: serum and urine sample

Other: serum and urine sample

Interventions

serum and urine sampleOTHER

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.

15 healthy volunteers

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Male or female above 18 years

You may qualify if:

  • Male or female, aged above 18 years.
  • Sign an informed consent after being informed
  • Able to follow the instructions of the study

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ATC SA, Unité de pharmacologie clinique, CHU Sart Tilman

Liège, Liege, 4000, Belgium

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum and urine samples

Study Officials

  • Bernard Jandrain, MD

    Clinical Pharmacology Unit, ATC sa, Belgium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2015

First Posted

January 28, 2015

Study Start

August 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

January 28, 2015

Record last verified: 2015-01

Locations

BE(1)