Reference Values of Circulating Endothelial Progenitor Cells | NCT01918969

Studies
Reference Values of Circulating Endothelial Progenitor Cells

NCT01918969

Sponsor

Hopital Jean Minjoz

Status

Unknown status

Last Update Posted

Aug 8, 2013Estimated

Enrollment

120Estimated

Phase

Not provided

Conditions

Aortic Aneurysm

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

Aug 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2013

Primary Completion Date

Jan 2014Estimated

Completion Date

Mar 2014Estimated

First Submitted Date

Aug 6, 2013

First Submission Date that Met QC Criteria

Aug 7, 2013

First Posted Date

Aug 8, 2013Estimated

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

Aug 7, 2013

Last Update Posted Date

Aug 8, 2013Estimated

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

Circulating endothelial progenitor cells CD34+144+CD14- et CD34+VEGF-R2+CD14- have been shown to be inversely correlated to aortic aneurysm size. However reference values have not yet been determined. This study is aimed to determine reference values of CD34+144+CD14- et CD34+VEGF-R2+CD14- in healthy men and women blood donors.

Detailed Description

At the time of blood donation, 10mL of blood will be used to calculate the concentration of circulating endothelial progenitor cells CD34+144+CD14- et CD34+VEGF-R2+CD14- , and the ratio of circulating endothelial progenitor cells CD34+144+CD14- et CD34+VEGF-R2+CD14- / all circulating endothelial progenitor cells in order to determine reference values.

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

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Blood donors		Blood donors with no exclusion criteria i.e with a very low probability to have an aortic aneurysm

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Concentration of circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14-		3 months

Secondary Outcomes

Measure	Description	Time Frame
Ratio of circulating endothelial progenitor cells CD34+144+CD14- et CD34+VEGF-R2+CD14- / all circulating endothelial progenitor cells		3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Blood donors

Exclusion Criteria:

age over 65
Arterial hypertension (treated or not)
Vascular disease
smoker or former smoker who stopped smoking for less than a year

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy blood donors

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sidney Chocron, MD, PhD	Contact	+33381533121		sidney.chocron@univ-fcomte.fr
Sidney Chocron, MD,PhD	Contact	+33381533121		sidney.chocron@univ-fcomte.fr

Overall Officials

Name	Affiliation	Role
Andrea Perrotti, MD	University of Franche-Comte; France	Principal Investigator
Pascal Morel, MD, PhD	Etablissement Français du Sang	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Besançon		Besançon		25030	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21481600	Background	Parietti E, Pallandre JR, Deschaseaux F, Aupecle B, Durst C, Kantelip JP, Chocron S, Davani S. Presence of circulating endothelial progenitor cells and levels of stromal-derived factor-1alpha are associated with ascending aorta aneurysm size. Eur J Cardiothorac Surg. 2011 Jul;40(1):e6-12. doi: 10.1016/j.ejcts.2011.02.065. Epub 2011 Apr 9.

ID	Term
D000783	Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D001018	Aortic Diseases