Use of Sentinel Cells for the Development of Molecular Te... | NCT01904825

Studies
Use of Sentinel Cells for the Development of Molecular Tests to Control the Quality of Cryopreservation

NCT01904825

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Withdrawn

Last Update Posted

Jul 22, 2013Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Aneurysm of the Abdominal Aorta

Interventions

Not provided

Countries

Not provided

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

Jul 2013

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Jul 12, 2013

First Submission Date that Met QC Criteria

Jul 19, 2013

First Posted Date

Jul 22, 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

Jul 19, 2013

Last Update Posted Date

Jul 22, 2013Estimated

Description Module

Brief 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.

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Quality sentinel cells		participants will be followed for the duration of hospital stay, an expected average of 6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Only patients of the CHU Dijon and Strasbourg

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alain BONNIN	CHU Dijon - Biological Resource Center	Principal Investigator

Locations

Not provided