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Biobank Based on the i-Share Student Cohort (bio-Share)

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ClinicalTrials.gov Identifier: NCT02568371
Recruitment Status : Completed
First Posted : October 5, 2015
Last Update Posted : March 18, 2019
Sponsor:
Collaborator:
National Research Agency, France
Information provided by (Responsible Party):
University Hospital, Bordeaux

Brief 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)

Condition or disease
Healthy

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.

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Study Type : Observational
Actual Enrollment : 1997 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Biobank Based on the i-Share Student Cohort
Actual Study Start Date : October 6, 2015
Actual Primary Completion Date : November 30, 2017
Actual Study Completion Date : November 30, 2017



Primary Outcome Measures :
  1. The acquisition date of blood samples [ Time Frame: Day 1 ]
  2. The number of the aliquots for each of the stored biological samples [ Time Frame: Day 1 ]
  3. The total volume of the aliquots for each of the stored biological samples [ Time Frame: Day 1 ]

Secondary Outcome Measures :
  1. Glucose (fasting) [ Time Frame: Day 1 ]
  2. Total cholesterol (fasting) [ Time Frame: Day 1 ]
  3. High-density lipoprotein cholesterol (fasting) [ Time Frame: Day 1 ]
  4. Low-density lipoprotein-cholesterol (fasting) [ Time Frame: Day 1 ]
  5. Triglycerides (fasting) [ Time Frame: Day 1 ]

Biospecimen Retention:   Samples With DNA
plasma ; serum ; whole blood ; red blood cells ; DNA ; RNA


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568371


Locations
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France
Centre Hospitalier Universitaire de Bordeaux - PELLEGRIN
Bordeaux, Aquitaine, France
Sponsors and Collaborators
University Hospital, Bordeaux
National Research Agency, France
Investigators
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Study Director: Stephanie DEBETTE, MD, PhD University of Bordeaux, Inserm U897, Bordeaux University Hospital
Study Director: Christophe TZOURIO, MD, PhD University of Bordeaux, Inserm U897, Bordeaux University Hospital
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT02568371    
Other Study ID Numbers: CHUBX2015/07
First Posted: October 5, 2015    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Keywords provided by University Hospital, Bordeaux:
biobank
DNA
genetic
young adults
cohort study