Healthybio-ShareNCT02568371
Biobank Based on the i-Share Student Cohort
An observational study of Healthy, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The bio-Share project aims at collecting blood samples in students participating in the i-Share cohort (www.i-share.fr). Investigators aim at setting up a platform that will enable investigators in the future to study biological determinants of conditions that affect young adults and to test certain hypotheses on the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 1,997 participants
- Where
- 1 siteFrance
- Study dates
- 6 Oct 2015to 30 Nov 2017
- 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: The bio-Share study is a biological repository embedded within the i-Share study, aiming at collecting blood samples from a subset of 2000 i-Share participants volunteering for this ancillary project.
Who may be able to join
- Be an i-Share participant in Bordeaux
- Being aged 18 years or more
- Being affiliated or beneficiary of a social security
- Having filled out the first online i-Share questionnaire
- Having signed a written informed consent
Who cannot join
- Pregnant or breastfeeding women,
- Persons who cannot personally give their consent and adults under guardianship.
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire de Bordeaux - PELLEGRIN
Bordeaux, Aquitaine
About this study
The bio-Share project aims at collecting blood samples in students participating in the i-Share cohort (www.i-share.fr). Investigators aim at setting up a platform that will enable investigators in the future to study biological determinants of conditions that affect young adults and to test certain hypotheses on the pathophysiology and mechanisms underlying diseases occurring both at a young age and later in life (as early exposures may also impact late onset diseases)
Read the detailed description
The i-Share cohort was set up to study various important aspects of students' health and to better understand early mechanisms contributing to the occurrence of common diseases representing an important public health burden. The i-Share cohort is funded by an "investment for the future grant" from the French National Research Agency (ANR-10-COHO-05-01) with the aim to recruit 30000 students at the University of Bordeaux, and a few additional partner universities in France and abroad (www.i-share.fr).
The bio-Share study is a biological repository embedded within the i-Share study, aiming at collecting blood samples (for genetic analyses as well as measurement of other biomarkers) from a subset of 2000 i-Share participants volunteering for this ancillary project.
The goal is to set up a platform that will enable investigators in the future to study biological determinants of conditions that affect young adults and to test certain hypotheses on the pathophysiology and mechanisms underlying diseases occurring both at a young age and later in life (as early exposures may also impact late onset diseases).
The biobank will comprise the following biological materials: plasma, serum, whole blood, red blood cells, DNA, RNA. Levels of fasting glucose and lipid levels (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides) will be returned to participants.
- Conditions
- Healthy
- Keywords
- biobank, DNA, genetic, young adults, cohort study
What is being measured
The primary outcome is the main question the study is designed to answer.
The acquisition date of blood samples
Measured: Day 1
The number of the aliquots for each of the stored biological samples
Measured: Day 1
The total volume of the aliquots for each of the stored biological samples
Measured: Day 1
Secondary outcomes (5)
Glucose (fasting)
Measured: Day 1
Total cholesterol (fasting)
Measured: Day 1
High-density lipoprotein cholesterol (fasting)
Measured: Day 1
Low-density lipoprotein-cholesterol (fasting)
Measured: Day 1
Triglycerides (fasting)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study start6 Oct 2015
- Primary completion30 Nov 2017
- Study completion30 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Time perspective
- Prospective
- Enrolment
- 1,997 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Agency, France
- Responsible party
- Sponsor
- Investigators
- Stephanie DEBETTE, MD, PhD, Study director, University of Bordeaux, Inserm U897, Bordeaux University HospitalChristophe TZOURIO, MD, PhD, Study director, University of Bordeaux, Inserm U897, Bordeaux University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568371
- Sponsor's protocol ID
- CHUBX2015/07
- Acronym
- bio-Share
- Status last verified
- Mar 2019
- First submitted
- 2 Oct 2015
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobank Based on the i-Share Student Cohort
- ClinicalTrials.gov ID
- NCT02568371
- Acronym / sponsor ID
- bio-Share / CHUBX2015/07
- Conditions
- Healthy
- Keywords
- biobank, DNA, genetic, young adults, cohort study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,997 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- National Research Agency, France
- Study start
- 6 Oct 2015 (actual)
- Primary completion
- 30 Nov 2017 (actual)
- Study completion
- 30 Nov 2017 (actual)
- First posted
- 5 Oct 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 bio-Share project aims at collecting blood samples in students participating in the i-Share cohort (www.i-share.fr). Investigators aim at setting up a platform that will enable investigators in the future to study biological determinants of conditions that affect young adults and to test certain hypotheses on the pathophysiology and mechanisms underlying diseases occurring both at a young age and later in life (as early exposures may also impact late onset diseases)
Detailed description
The i-Share cohort was set up to study various important aspects of students' health and to better understand early mechanisms contributing to the occurrence of common diseases representing an important public health burden. The i-Share cohort is funded by an "investment for the future grant" from the French National Research Agency (ANR-10-COHO-05-01) with the aim to recruit 30000 students at the University of Bordeaux, and a few additional partner universities in France and abroad (www.i-share.fr).
The bio-Share study is a biological repository embedded within the i-Share study, aiming at collecting blood samples (for genetic analyses as well as measurement of other biomarkers) from a subset of 2000 i-Share participants volunteering for this ancillary project.
The goal is to set up a platform that will enable investigators in the future to study biological determinants of conditions that affect young adults and to test certain hypotheses on the pathophysiology and mechanisms underlying diseases occurring both at a young age and later in life (as early exposures may also impact late onset diseases).
The biobank will comprise the following biological materials: plasma, serum, whole blood, red blood cells, DNA, RNA. Levels of fasting glucose and lipid levels (total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides) will be returned to participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The bio-Share study is a biological repository embedded within the i-Share study, aiming at collecting blood samples from a subset of 2000 i-Share participants volunteering for this ancillary project.
Key inclusion criteria (5 listed)
- Be an i-Share participant in Bordeaux
- Being aged 18 years or more
- Being affiliated or beneficiary of a social security
- Having filled out the first online i-Share questionnaire
- Having signed a written informed consent
Key exclusion criteria (2 listed)
- Pregnant or breastfeeding women,
- Persons who cannot personally give their consent and adults 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.
Primary outcome
The acquisition date of blood samples
Time frame: Day 1
The number of the aliquots for each of the stored biological samples
Time frame: Day 1
The total volume of the aliquots for each of the stored biological samples
Time frame: Day 1
5 secondary outcomes
Glucose (fasting)
Time frame: Day 1
Total cholesterol (fasting)
Time frame: Day 1
High-density lipoprotein cholesterol (fasting)
Time frame: Day 1
Low-density lipoprotein-cholesterol (fasting)
Time frame: Day 1
Triglycerides (fasting)
Time frame: Day 1
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 18 Mar 2019.
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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.
Stephanie DEBETTE, MD, PhD study director
University of Bordeaux, Inserm U897, Bordeaux University Hospital
Christophe TZOURIO, MD, PhD study director
University of Bordeaux, Inserm U897, Bordeaux University Hospital
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 Healthy, run by University Hospital, Bordeaux at 1 site in France.
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 5 inclusion and 2 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 18 Mar 2019. 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 France. 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?
The acquisition date of blood samples (time frame: Day 1). The study lists 3 primary outcomes in all. 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 18 Mar 2019.