Studieoverzicht - 2016-03 PRECISE

 
Number 2016-03 PRECISE
Nickname PRECiSE
Status Open Date: 10-05-2017
Inclusion closed
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 241 Date: 31-10-2018
Estimated study completion date 31-12-2020
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 http://www.boogstudycenter.nl
Sponsor BOOG
Principal Investigator(s) Dr. A. Jager (Erasmus MC Cancer Institute), Dr. G.S. Sonke (Netherlands Cancer Institute)
Study manager T.W. Volker, MSc, Projectmedewerker
Dr. A.E. van Leeuwen-Stok, Clinical Study Manager
Central datamanagement and randomization IKNL trialbureau
E-mail: trialbureau@iknl.nl
Phone +31-(0)88-234 6500
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

Documents (protected):
In order to see this content you need to be logged on.

Login.

Back