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PRECiSE

  • Follow up

BOOG 2016-03

General Information

BOOG number

BOOG 2016-03

Nickname

PRECiSE

Status

  • Follow up
Date: 23/05/2022

Inclusion closed

12/04/2022

Full title

Discovery of prognostic molecular markers within an early stage breast cancer patient population

Indication

  • Adjuvant

Subindication

Not applicable

Target sample size

1000

Actual accrual

1023
Date: 12/04/2022

Estimated study completion date

30/04/2022

Contact

Sponsor

BOOG

Principal Investigator(s)

Dr. A. Jager (Erasmus MC Cancer Institute), Prof. dr. G.S. Sonke (Netherlands Cancer Institute)

Study manager

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

Other

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.

Mamma- and Blueprint® results Breast cancer patient eligible for PRECiSE project

Patients:  signs informed consent

BOOG receives full genome expression data (database located at EMC Lab Genetics and Proteomics)

Physician/research nurse: fills in registration form

Agendia: determines besides Mammaprint®, full genome expression data

In case it is patient ‘s wish* to be informed about potential clinical relevant gene expression data (via treating physician)

*indicated on informed consent form

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.

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

Regulatory Information

CCMO approval

Yes

EC approval

Not applicable
Date: 02/05/2016
Nr:MEC-2016-266

EC

Erasmus Medisch Centrum Rotterdam

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