Effects of; SerumCOVARNCT02348944
Biological Variability in Cartilage Specific Biomarkers in Healthy Volunteers.
An observational study of Effects of; Serum and Urine Marking, run by Artialis at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Effects of; Serum, Urine Marking
- What is being tested?
- serum and urine sample
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2013to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Male or female above 18 years
Who may be able to join
- Male or female, aged above 18 years.
- Sign an informed consent after being informed
- Able to follow the instructions of the study
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site
ATC SA, Unité de pharmacologie clinique, CHU Sart Tilman
Liège, Liege, 4000
About this study
Official title: Evaluation of Biological Variability in Cartilage Specific Biomarkers (Coll2-1, Coll2-1NO2, FIB3-1 and FIB 3-2) 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.
Read the 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.
- Conditions
- Effects of; Serum, Urine Marking
- Being tested
- serum and urine sample
- Keywords
- Biological markers, Cartilage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 15 healthy volunteers | Other: serum and urine sample Receives: Other: serum and urine sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline and weeks 2, 16, 52 and 68
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2015 (estimated)
- Study startAug 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of; SerumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Artialis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bernard Jandrain, MD, Principal investigator, Clinical Pharmacology Unit, ATC sa, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02348944
- Sponsor's protocol ID
- COVAR
- Acronym
- COVAR
- Status last verified
- Jan 2015
- First submitted
- 19 Jan 2015
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Biological Variability in Cartilage Specific Biomarkers (Coll2-1, Coll2-1NO2, FIB3-1 and FIB 3-2) in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT02348944
- Acronym / sponsor ID
- COVAR / COVAR
- Conditions
- Effects of; Serum, Urine Marking
- Keywords
- Biological markers, Cartilage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- ArtialisIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 15 healthy volunteers | – | Other: serum and urine sampleOther: serum and urine sample |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female above 18 years
Key inclusion criteria (3 listed)
- Male or female, aged above 18 years.
- Sign an informed consent after being informed
- Able to follow the instructions of the study
Key exclusion criteria (6 listed)
- Serious associated diseases:
- Patient who are the subject of a judicial protection measure or under guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serum and urine sampleSerum 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. | Other | 15 healthy volunteers |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard Jandrain, MD principal investigator
Clinical Pharmacology Unit, ATC sa, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Effects of; Serum and Urine Marking, run by Artialis at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2015.