Thoracic or Abdominal Aortic Aneurysm With no Indication for Surgical TreatmentANOPEC 3NCT02919709
Follow up of Patients With Aortic Aneurysm by Dosage of Circulant Endothelial Progenitor Cells
A study testing blood taking in people with Thoracic or Abdominal Aortic Aneurysm With no Indication for Surgical Treatment, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The study aims to investigate the existence of a reliable correlation between the progression of aortic diameters and blood levels of circulant endothelial progenitor cells CD34+ in patients with not surgical aortic aneurysms. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracic or Abdominal Aortic Aneurysm With no Indication for Surgical Treatment
- What is being tested?
- blood taking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Nov 2018
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 or more.
- Patients diagnosed with a thoracic or abdominal aortic aneurysm with no indication for surgical treatment (diameters > 30 mm but < 50 mm).
- Patients accepting to sign a specific informed consent.
Who cannot join
- Unstable coronary artery disease.
- Congenital heart disease.
- Any evolving infectious syndrome or viral infection (HIV, HBV or HCV).
- Any chronic inflammatory or autoimmune disease.
- Prior administration of G-CSF; EPO; GM-CSF.
- Liver failure.
Show all 10Show fewer
- Prior oncologic disease or ongoing cancer with a life expectancy < 1 year.
- Dementia.
- Pregnancy.
- Patients aged < 18.
Trial locations and contacts
1 site in 1 country.
Andrea PERROTTI, MD contact
France1 site, 1 recruiting
- Recruiting
CHRU de Besançon
Besançon, 25000
Andréa PERROTTI, MD, aperrotti@chu-besancon.fr
About this study
The study aims to investigate the existence of a reliable correlation between the progression of aortic diameters and blood levels of circulant endothelial progenitor cells CD34+ in patients with not surgical aortic aneurysms.
- Being tested
- blood taking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood takingBiological
| Study group | Role | What they receive |
|---|---|---|
| thoracic or abdominal aortic aneurysm | Experimental | Not described Receives: Biological: blood taking |
What is being measured
The primary outcome is the main question the study is designed to answer.
progenitor cells CD34+ blood levels
Measured: At diagnosis of aneurysm
progenitor cells CD34+ blood levels
Measured: 6 month after disgnosis
progenitor cells CD34+ blood levels
Measured: 12 month after diagnosis
progenitor cells CD34+ blood levels
Measured: 18 month after diagnosis
progenitor cells CD34+ blood levels
Measured: 24 month after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2016 (estimated)
- Study startNov 2013
- Primary completionNov 2018 (estimated)
- Study completionNov 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thoracic or Abdominal Aortic Aneurysm With no Indication for Surgical TreatmentStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02919709
- Sponsor's protocol ID
- P/2013/186
- Acronym
- ANOPEC 3
- Status last verified
- Jul 2018
- First submitted
- 27 Sep 2016
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow up of Patients With Aortic Aneurysm by Dosage of Circulant Endothelial Progenitor Cells
- ClinicalTrials.gov ID
- NCT02919709
- Acronym / sponsor ID
- ANOPEC 3 / P/2013/186
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2018 (estimated)
- Study completion
- Nov 2018 (estimated)
- First posted
- 29 Sep 2016 (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.
The study aims to investigate the existence of a reliable correlation between the progression of aortic diameters and blood levels of circulant endothelial progenitor cells CD34+ in patients with not surgical aortic aneurysms.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| thoracic or abdominal aortic aneurysm | Experimental | Biological: blood taking |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 or more.
- Patients diagnosed with a thoracic or abdominal aortic aneurysm with no indication for surgical treatment (diameters > 30 mm but < 50 mm).
- Patients accepting to sign a specific informed consent.
Key exclusion criteria (10 listed)
- Unstable coronary artery disease.
- Congenital heart disease.
- Any evolving infectious syndrome or viral infection (HIV, HBV or HCV).
- Any chronic inflammatory or autoimmune disease.
- Prior administration of G-CSF; EPO; GM-CSF.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood taking | Biological | thoracic or abdominal aortic aneurysm |
Primary outcome
progenitor cells CD34+ blood levels
Time frame: At diagnosis of aneurysm
progenitor cells CD34+ blood levels
Time frame: 6 month after disgnosis
progenitor cells CD34+ blood levels
Time frame: 12 month after diagnosis
progenitor cells CD34+ blood levels
Time frame: 18 month after diagnosis
progenitor cells CD34+ blood levels
Time frame: 24 month after diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Individual participant dataSharing planned: No
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 contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing blood taking in people with Thoracic or Abdominal Aortic Aneurysm With no Indication for Surgical Treatment, run by Centre Hospitalier Universitaire de Besancon 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 3 inclusion and 10 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 18 Jul 2018. 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 Andrea PERROTTI, MD (aperrotti@chu-besancon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progenitor cells CD34+ blood levels (time frame: At diagnosis of aneurysm). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2018.