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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02568371
Other study ID # CHUBX2015/07
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 6, 2015
Est. completion date November 30, 2017

Study information

Verified date March 2019
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 pathophysiology and mechanisms underlying diseases occurring both at a young age and later in life (as early exposures may also impact late onset diseases)


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.


Recruitment information / eligibility

Status Completed
Enrollment 1997
Est. completion date November 30, 2017
Est. primary completion date November 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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

Exclusion Criteria:

- Pregnant or breastfeeding women,

- Persons who cannot personally give their consent and adults under guardianship.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Centre Hospitalier Universitaire de Bordeaux - PELLEGRIN Bordeaux Aquitaine

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Bordeaux National Research Agency, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary The acquisition date of blood samples Day 1
Primary The number of the aliquots for each of the stored biological samples Day 1
Primary The total volume of the aliquots for each of the stored biological samples Day 1
Secondary Glucose (fasting) Day 1
Secondary Total cholesterol (fasting) Day 1
Secondary High-density lipoprotein cholesterol (fasting) Day 1
Secondary Low-density lipoprotein-cholesterol (fasting) Day 1
Secondary Triglycerides (fasting) Day 1
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