Studieoverzicht - 2016-03 PRECISE
| Number | 2016-03 PRECISE | ||||
| Nickname | PRECiSE | ||||
| Status | Follow up | Date: 23-05-2022 | |||
| Inclusion closed | 12-04-2022 | ||||
| Other study number(s) | |||||
| Participating parties/groups | |||||
| Full title | Discovery of prognostic molecular markers within an early stage breast cancer patient population | ||||
| Phase and type | observational | ||||
| Age | ≥ 18 | ||||
| Menopausal status | Not applicable | ||||
| Indication | Adjuvant | ||||
| Subindication | Not applicable | ||||
| Target sample size | 1000 | ||||
| Actual accrual | 1023 | Date: 12-04-2022 | |||
| Estimated study completion date | 30-04-2022 | ||||
| CCMO approval | Not applicable | Date: | Nr: | ||
| EudraCT nr. | |||||
| Trial Register | |||||
| METC approval | Not applicable | Date: 02-05-2016 | METC: Erasmus Medisch Centrum Rotterdam | Nr: MEC-2016-266 | |
| Amendments | Date: | ||||
| KWF-CKS approval | Date: | Nr: | |||
| News item | |||||
| Website | , voor patienten: https://www.kanker.nl/trials/1006-boog-2016-03-precise-project-borstkanker | ||||
| Sponsor | BOOG | ||||
| Principal Investigator(s) | Dr. A. Jager (Erasmus MC Cancer Institute), Prof. dr. G.S. Sonke (Netherlands Cancer Institute) | |||
| Study manager | T.W. Volker, MSc, Projectmedewerker Dr. A.E. van Leeuwen-Stok, Clinical Study Manager |
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| Central datamanagement and randomization | IKNL trialbureau E-mail: trialbureau@iknl.nl Phone +31-(0)88-234 6500 |
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| Monitoring | Not applicable | |||
| Local datamanagement | IKNL / NKR | |||
| Funding | Agendia | |||
| Extra | Submitted to METC of Erasmus MC (MEC-2016-266) and judged being not applicable to WMO registration d.d. 02-May-2016. | |||
Design:
This is a prospective population-based registry.
Objectives:
This prospective, nation-wide, population-based Dutch registry will provide data for research in order to identify new genes/ gene sets that are of prognostic and/or predictive value in patients with primary breast cancer.
- Setting up a national population-based registry of full human genome gene expression data.
- Linking gene expression data and NCR data in a unique database to allow combined analyses of gene expression, clinical, pathological, treatment and outcome data.
- To identify new genes/ gene sets that are of prognostic and/or predictive value, when combined with clinical and pathological factors, in breast cancer patients of whom the primary breast tumor underwent MammaPrint® testing for daily practice.
Endpoints:
Main eligibility criteria:
- Male or female
- Age 18 years or older
- Recently diagnosed early stage breast cancer for whom is decided to apply for MammaPrint® testing on the primary breast tumor
- Written informed consent
Documents (public):
Protocol synopsis
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