WHO trial registration data set
| Primary registry and trial identifying number | ClinicalTrials.gov: NCT03320408 |
| Date of registration in primary registry | 25 October 2017 |
| Secondary identifying numbers | NL59991.018.17, PARIS study, biobank Pearl AAA |
| Sources of monetary of material support | AMC Foundation for monetary support. |
| Primary sponsor | Academic Medical Center – University of Amsterdam |
| Secondary sponsor(s) | None |
| Contact for public queries | Els Kuiters, e.kuiters@amsterdamumc.nl,+31205667832, Meibergdreef 9, 1105AZ, Amsterdam, The Netherlands. |
| Contact for scientific queries | Principal investigator: Professor R Balm, r.balm@amsterdamumc.nl,+3120–5667832, Meibergdreef 9, 1105AZ, Amsterdam, The Netherlands. Els Kuiters, e.kuiters@amsterdamumc.nl,+31205667832, Meibergdreef 9, 1105AZ, Amsterdam, the Netherlands. |
| Public title | PARIS study and biobank Pearl AAA |
| Scientific title | Predicting aneurysm growth and rupture with longitudinal biomarkers (PARIS study) and biobank Pearl AAA. |
| Countries of recruitment | The Netherlands |
| Health condition(s) | Abdominal aortic aneurysm |
| Intervention(s) | None |
| Key inclusion and exclusion criteria | Inclusion criteria: adult with an AAA or who has been previously treated for an AAA. Adequate comprehension of the Dutch language to provide written informed consent. Exclusion criteria: decisionally impaired patients. The exception are patients who are decisionally impaired due to the effects of an acute AAA for whom a separate recruitment and consent procedure exists. |
| Study type | Observational longitudinal patient registry and biobank |
| Date of first enrolment | 4 October 2017 |
| Sample size | Planned: 750 Currently enrolled: 161 |
| Recruitment status | Recruiting; participants are currently being recruited and enrolled |
| Primary outcome(s) | Outcome: AAA growth. Time frame: up to 10 years of follow-up. Outcome. AAA rupture. Time frame: up to 10 years of follow-up. Outcome: all-cause mortality. Time frame: up to 10 years of follow-up. Outcome: evolution of serum levels of proteases and cytokines. Time frame: a maximum of 1 measurement annually up to 10 years of follow-up. Outcome: proteases and cytokine levels in AAA tissue. Time frame: if open AAA repair is performed and AAA tissue is collected. This is a one-time measurement. |
| Key secondary outcome(s) | Outcome: incidence and type of complications after AAA repair. Time frame: up to 10 years of follow-up after AAA repair. |
| Ethics review | Status: approved. Date of approval: 25 August 2017. Name and contact details of ethics committees: Medical Ethics Board of Amsterdam UMC (University of Amsterdam). mecamc@amc.uva.nl,+31205667389, Trinity building C, fourth floor, Pietersbergweg 17, 1105BM Amsterdam, The Netherlands. Biobank Ethics Board of Amsterdam UMC (University of Amsterdam), biobanktoetsing@amc.uva.nl,+=31205666730, Meibergdreef 9, 1105AZ, Amsterdam, The Netherlands. |
| Completion date | Expected: 4 October 2032 |
| Summary results | No results yet. |
| IPD sharing statement | Plan to share IPD: yes. Plan description: IPD sharing for research will be allowed in a data sharing procedure. Scientific requests need to fall under the scope of the scientific aims as formulated in this manuscript. Researchers willing to requests IPD can initiate this procedure by contacting the researchers. Data will be released depending on the scientific quality of the submitted request. |
AAA, abdominal aortic aneurysm; PARIS, Predicting aneurysm growth and rupture with longitudinal biomarkers.