Aortic AneurysmANOPEC2NCT01918969
Reference Values of Circulating Endothelial Progenitor Cells
An observational study of Aortic Aneurysm, run by Hopital Jean Minjoz at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Aortic Aneurysm
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Mar 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy blood donors
Who may be able to join
- Blood donors
Who cannot join
- age over 65
- Arterial hypertension (treated or not)
- Vascular disease
- smoker or former smoker who stopped smoking for less than a year
Trial locations and contacts
1 site in 1 country.
France1 site
CHU Besançon
Besançon, 25030
Sidney Chocron, MD, PhD, +33381533121, sidney.chocron@univ-fcomte.fr
About this study
Official title: Determination of Reference Values of Circulating Endothelial Progenitor Cells CD34+144+CD14- and CD34+VEGF-R2+CD14- in a Blood Donnor Population
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.
Read the 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.
- Conditions
- Aortic Aneurysm
- Keywords
- Endothelial progenitor cells, Healthy blood donors
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Blood donors | Blood donors with no exclusion criteria i.e with a very low probability to have an aortic aneurysm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14-
Measured: 3 months
Secondary outcomes (1)
Ratio of circulating endothelial progenitor cells CD34+144+CD14- et CD34+VEGF-R2+CD14- / all circulating endothelial progenitor cells
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2013 (estimated)
- Study startOct 2013
- Primary completionJan 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Jean Minjoz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Sidney Chocron, Hopital Jean Minjoz
- Investigators
- Andrea Perrotti, MD, Principal investigator, University of Franche-Comte; FrancePascal Morel, MD, PhD, Principal investigator, Etablissement Français du SangSiamak Davani, MD, PhD, Study chair, University of Franche-Comte. france
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01918969
- Sponsor's protocol ID
- 13/408
- Acronym
- ANOPEC2
- Status last verified
- Aug 2013
- First submitted
- 6 Aug 2013
- Last updated
- 8 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21481600
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Reference Values of Circulating Endothelial Progenitor Cells CD34+144+CD14- and CD34+VEGF-R2+CD14- in a Blood Donnor Population
- ClinicalTrials.gov ID
- NCT01918969
- Acronym / sponsor ID
- ANOPEC2 / 13/408
- Conditions
- Aortic Aneurysm
- Keywords
- Endothelial progenitor cells, Healthy blood donors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hopital Jean MinjozUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Jan 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 8 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood donors | – | –Blood donors with no exclusion criteria i.e with a very low probability to have an aortic aneurysm |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy blood donors
Key inclusion criteria (1 listed)
- Blood donors
Key exclusion criteria (4 listed)
- age over 65
- Arterial hypertension (treated or not)
- Vascular disease
- smoker or former smoker who stopped smoking for less than a year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Concentration of circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14-
Time frame: 3 months
1 secondary outcome
Ratio of circulating endothelial progenitor cells CD34+144+CD14- et CD34+VEGF-R2+CD14- / all circulating endothelial progenitor cells
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2013.
- Background: PubMed 21481600Parietti 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Perrotti, MD principal investigator
University of Franche-Comte; France
Pascal Morel, MD, PhD principal investigator
Etablissement Français du Sang
Siamak Davani, MD, PhD study chair
University of Franche-Comte. france
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aortic Aneurysm, run by Hopital Jean Minjoz at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sidney Chocron, MD, PhD (+33381533121, sidney.chocron@univ-fcomte.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of circulating endothelial progenitor cells CD34+144+CD14- and CD34+VEGF-R2+CD14- (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01918969, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2013.