Condition category
Cancer
Date applied
27/02/2007
Date assigned
27/02/2007
Last edited
21/12/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.microarrays.nl

Contact information

Type

Scientific

Primary contact

Dr S C Linn

ORCID ID

Contact details

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL)
Plesmanlaan 121
Amsterdam
1066 CX
Netherlands
+31 (0)20 512 2951
s.linn@nki.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

RASTER

Study hypothesis

Recently we have identified a gene expression profile of 70 genes using microarray analysis, which was a more powerful prognostic factor for freedom of distant metastases than current clinicopathological features in node negative breast cancer patients up to 55 years of age. To assess whether this 70-gene microarray test can be implemented in daily clinical practice we aimed to answer the following three questions:
1. Is it feasible to collect fresh tumour samples in order to make this test available in pN0 breast cancer patients in community hospitals?
2. What is the proportion of a ‘high’ versus a ‘low’ risk profile in node negative patients?
3. What is the concordance between the 70-gene microarray risk profile and the metastasis risk as assessed with current Dutch guidelines based on clinicopathological factors (such as age, pT, tumour grade, hormonal receptor-status)?

Primary hypothesis: The implementation of microarray diagnostics is feasible in general practice in community hospitals.

Ethics approval

Approval received from the local ethics committee (Protocol Toetsingscommissie) on the 8th October 2003 (study ref: MO3ARR; letter ref: EV03-464).

Study design

Non-randomised, non-controlled, diagnostic multicentre clinical trial

Primary study design

Interventional

Secondary study design

Multi-centre

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Condition

Breast cancer

Intervention

Diagnostic intervention with the 70-gene microarray profile giving a result of 'high' or 'low' risk for distant metastasis and death.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The amount of successfully performed diagnostic microarray tests as a proportion of the total number of accrued patients.

Secondary outcome measures

1. To assess the proportion of a 'high' versus a 'low' risk profile in lymph node negative breast cancer patients
2. To assess the concordance between the 70-gene microarray risk profile and the metastasis risk as assessed with current Dutch guidelines based on clinicopathological factors (such as age, pT, tumor grade, hormonal receptor-status)

Overall trial start date

22/01/2004

Overall trial end date

31/12/2006

Reason abandoned

Eligibility

Participant inclusion criteria

1. Female patients
2. With primary operable unifocal breast cancer
3. Without clinical signs of lymph node involvement or distant metastasis
4. Younger than 55 years of age

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

750

Participant exclusion criteria

A prior history of any malignancy with the exception of cervical dysplasia and basal cell carcinoma.

Recruitment start date

22/01/2004

Recruitment end date

31/12/2006

Locations

Countries of recruitment

Netherlands

Trial participating centre

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL)
Amsterdam
1066 CX
Netherlands

Sponsor information

Organisation

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL) (The Netherlands)

Sponsor details

Plesmanlaan 121
Amsterdam
1066 CX
Netherlands

Sponsor type

Charity

Website

http://www.nki.nl/

Funders

Funder type

Industry

Funder name

Dutch Health Care Insurance Board (CVZ) (The Netherlands) - independent government organisation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Agendia B.V. (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/18042430
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/19955335

Publication citations

  1. Results

    Bueno-de-Mesquita JM, van Harten WH, Retel VP, van't Veer LJ, van Dam FS, Karsenberg K, Douma KF, van Tinteren H, Peterse JL, Wesseling J, Wu TS, Atsma D, Rutgers EJ, Brink G, Floore AN, Glas AM, Roumen RM, Bellot FE, van Krimpen C, Rodenhuis S, van de Vijver MJ, Linn SC, Use of 70-gene signature to predict prognosis of patients with node-negative breast cancer: a prospective community-based feasibility study (RASTER)., Lancet Oncol., 2007, 8, 12, 1079-1087, doi: 10.1016/S1470-2045(07)70346-7.

  2. Results

    Bueno-de-Mesquita JM, Sonke GS, van de Vijver MJ, Linn SC, Additional value and potential use of the 70-gene prognosis signature in node-negative breast cancer in daily clinical practice., Ann. Oncol., 2011, 22, 9, 2021-2030, doi: 10.1093/annonc/mdp547.

Additional files

Editorial Notes