Ignite Creation Date:
2024-05-06 @ 10:40 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03320408
Status:
COMPLETED
Last Update Posted:
2023-08-22
First Post:
2017-10-12
Brief Title:
Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers
Sponsor:
Ron Balm
Organization:
Academisch Medisch Centrum - Universiteit van Amsterdam AMC-UvA
Study Overview
Official Title:
Predicting Aneurysm Growth and Rupture With Longitudinal Biomarkers PARIS Study Biobank Pearl AAA
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PARIS
Brief Summary:
First aim PARIS study
The main aim of the current study is to determine the association between abdominal aortic aneurysm AAA progression and the evolution of proteases and cytokines levelsTo achieve this aim we will prospectively collect blood aortic tissue patient data and imaging data Aortic tissue will only be obtained when patients undergo conventional open repair The other biomaterials will be collected during regular patient follow-up visits with a maximum frequency of once per year
Second aim Pearl AAA biobank
For future research purposes a new biobanking infrastructure will be created to collect and store additional blood and urine samples in a biobank This biobank will be embedded within the infrastructure of the Parelsnoer Institute PSI and will be called Pearl AAA The Pearl AAA will be established in the extension of the PARIS study
The main aim of the current study is to determine the association between abdominal aortic aneurysm AAA progression and the evolution of proteases and cytokines levelsTo achieve this aim we will prospectively collect blood aortic tissue patient data and imaging data Aortic tissue will only be obtained when patients undergo conventional open repair The other biomaterials will be collected during regular patient follow-up visits with a maximum frequency of once per year
Second aim Pearl AAA biobank
For future research purposes a new biobanking infrastructure will be created to collect and store additional blood and urine samples in a biobank This biobank will be embedded within the infrastructure of the Parelsnoer Institute PSI and will be called Pearl AAA The Pearl AAA will be established in the extension of the PARIS study
Detailed Description:
The PARIS study aims to determine the correlation between AAA progression growth or rupture and the evolution of serum levels of proteases and cytokines over time A repeated measures analysis will be done to use all longitudinal data available
The Pearl AAA biobank will be established to enable the PARIS study but also aims to facilitate future research Such future research should fall under the scientific aims of the Pearl AAA which are
To gain insight in the pathogenesis of AAA
To gain more knowledge in the rupture risk of AAA
To evaluate and potentially improve treatment of AAA
The Parelsnoer Institute will facilitate the biobank Pearl AAA with certain aspects such as but not limited to the following
Standardized operating procedures for the collection and storage of the biosamples across all participating hospitals
Information architect to establish a data dictionary in which all variables are defined
Standardized procedures for coding of patient data before storage
Standardized digital infrastructure to enhance storage of patient data and imaging data
The Pearl AAA biobank will be established to enable the PARIS study but also aims to facilitate future research Such future research should fall under the scientific aims of the Pearl AAA which are
To gain insight in the pathogenesis of AAA
To gain more knowledge in the rupture risk of AAA
To evaluate and potentially improve treatment of AAA
The Parelsnoer Institute will facilitate the biobank Pearl AAA with certain aspects such as but not limited to the following
Standardized operating procedures for the collection and storage of the biosamples across all participating hospitals
Information architect to establish a data dictionary in which all variables are defined
Standardized procedures for coding of patient data before storage
Standardized digital infrastructure to enhance storage of patient data and imaging data
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Biobank Pearl AAA | REGISTRY | Biobank Pearl AAA | None |