Reference Values of Circulating Endothelial Progenitor Cells (ANOPEC2)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by Hopital Jean Minjoz
Sponsor:
Information provided by (Responsible Party):
Prof. Sidney Chocron, Hopital Jean Minjoz
ClinicalTrials.gov Identifier:
NCT01918969
First received: August 6, 2013
Last updated: August 7, 2013
Last verified: August 2013
  Purpose

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.


Condition
Aortic Aneurysm

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Determination of Reference Values of Circulating Endothelial Progenitor Cells CD34+144+CD14- and CD34+VEGF-R2+CD14- in a Blood Donnor Population

Resource links provided by NLM:


Further study details as provided by Hopital Jean Minjoz:

Primary Outcome Measures:
  • Concentration of circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ratio of circulating endothelial progenitor cells CD34+144+CD14- et CD34+VEGF-R2+CD14- / all circulating endothelial progenitor cells [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Blood


Estimated Enrollment: 120
Study Start Date: October 2013
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Blood donors
Blood donors with no exclusion criteria i.e with a very low probability to have an aortic aneurysm

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy blood donors

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01918969

Contacts
Contact: Sidney Chocron, MD, PhD +33381533121 sidney.chocron@univ-fcomte.fr
Contact: Sidney Chocron, MD,PhD +33381533121 sidney.chocron@univ-fcomte.fr

Locations
France
CHU Besançon Not yet recruiting
Besançon, France, 25030
Contact: Sidney Chocron, MD, PhD    +33381533121    sidney.chocron@univ-fcomte.fr   
Sponsors and Collaborators
Hopital Jean Minjoz
Investigators
Principal Investigator: Andrea Perrotti, MD University of Franche-Comte; France
Principal Investigator: Pascal Morel, MD, PhD Etablissement Français du Sang
Study Chair: Siamak Davani, MD, PhD University of Franche-Comte. france
  More Information

Publications:
Responsible Party: Prof. Sidney Chocron, MD, PhD, Hopital Jean Minjoz
ClinicalTrials.gov Identifier: NCT01918969     History of Changes
Other Study ID Numbers: 13/408
Study First Received: August 6, 2013
Last Updated: August 7, 2013
Health Authority: France: Health agency

Keywords provided by Hopital Jean Minjoz:
Endothelial progenitor cells
Healthy blood donors

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on July 29, 2014