Biobank Based on the i-Share Student Cohort | NCT02568371

Studies
Biobank Based on the i-Share Student Cohort

NCT02568371

Sponsor

University Hospital, Bordeaux

Status

Completed

Last Update Posted

Mar 18, 2019Actual

Enrollment

1,997Actual

Phase

Not provided

Conditions

Healthy

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 6, 2015Actual

Primary Completion Date

Nov 30, 2017Actual

Completion Date

Nov 30, 2017Actual

First Submitted Date

Oct 2, 2015

First Submission Date that Met QC Criteria

Oct 2, 2015

First Posted Date

Oct 5, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2019

Last Update Posted Date

Mar 18, 2019Actual

Name	Class
National Research Agency, France	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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)

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,997Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The acquisition date of blood samples		Day 1
The number of the aliquots for each of the stored biological samples		Day 1
The total volume of the aliquots for each of the stored biological samples		Day 1

Secondary Outcomes

Measure	Description	Time Frame
Glucose (fasting)		Day 1
Total cholesterol (fasting)		Day 1
High-density lipoprotein cholesterol (fasting)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Universitaire de Bordeaux - PELLEGRIN		Bordeaux	Aquitaine		France