Aneurysm of the Abdominal AortaNCT01904825
Use of Sentinel Cells for the Development of Molecular Tests to Control the Quality of Cryopreservation
An observational study of Aneurysm of the Abdominal Aorta, run by Centre Hospitalier Universitaire Dijon.
Trial summary
The aim is to set up tools that will serve as quality tracers for cryopreservation procedures. To meet this objective, we have chosen to develop reference samples (sentinel cells) that, in the medium term, can be used as controls to guarantee the quality of preservation for biological samples. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysm of the Abdominal Aorta
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Aug 2009
- How long will I take part?
- 1 Day
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Only patients of the CHU Dijon and Strasbourg
Who may be able to join
- Age > or = 18 years
- All patients presenting an abdominal aorta diameter of at least 5 cm at the time of discovery and who have surgery
Who cannot join
- Patients who do not have aneurysm of the abdominal aorta
- Refusal to sign the consent form for participation
- Patients who do not wish to have their operation in Dijon or Strasbourg CHU
About this study
The aim is to set up tools that will serve as quality tracers for cryopreservation procedures.
To meet this objective, we have chosen to develop reference samples (sentinel cells) that, in the medium term, can be used as controls to guarantee the quality of preservation for biological samples.
The biological tools and an optimised follow-up strategy will make it possible to validate preservation procedures at the CRB in order to guarantee the perfect stability of samples and the validity of clinical studies.
- Conditions
- Aneurysm of the Abdominal Aorta
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality sentinel cells
Measured: participants will be followed for the duration of hospital stay, an expected average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2013 (estimated)
- Study startSep 2006
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysm of the Abdominal AortaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alain BONNIN, Principal investigator, CHU Dijon - Biological Resource Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01904825
- Sponsor's protocol ID
- Bonnin PHRC IR 2006
- Status last verified
- Jul 2013
- First submitted
- 12 Jul 2013
- Last updated
- 22 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Sentinel Cells for the Development of Molecular Tests to Control the Quality of Cryopreservation
- ClinicalTrials.gov ID
- NCT01904825
- Acronym / sponsor ID
- Bonnin PHRC IR 2006
- Conditions
- Aneurysm of the Abdominal Aorta
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 22 Jul 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.
The aim is to set up tools that will serve as quality tracers for cryopreservation procedures.
To meet this objective, we have chosen to develop reference samples (sentinel cells) that, in the medium term, can be used as controls to guarantee the quality of preservation for biological samples.
The biological tools and an optimised follow-up strategy will make it possible to validate preservation procedures at the CRB in order to guarantee the perfect stability of samples and the validity of clinical studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Only patients of the CHU Dijon and Strasbourg
Key inclusion criteria (2 listed)
- Age > or = 18 years
- All patients presenting an abdominal aorta diameter of at least 5 cm at the time of discovery and who have surgery
Key exclusion criteria (3 listed)
- Patients who do not have aneurysm of the abdominal aorta
- Refusal to sign the consent form for participation
- Patients who do not wish to have their operation in Dijon or Strasbourg CHU
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
Quality sentinel cells
Time frame: participants will be followed for the duration of hospital stay, an expected average of 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2013.
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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.
Alain BONNIN principal investigator
CHU Dijon - Biological Resource Center
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysm of the Abdominal Aorta, run by Centre Hospitalier Universitaire Dijon.
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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 22 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality sentinel cells (time frame: participants will be followed for the duration of hospital stay, an expected average of 6 months). 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 22 Jul 2013.