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The implementation of microarrays in cancer diagnosis (Microarray prognostics in breast cancer).


- candidate number1546
- NTR NumberNTR446
- ISRCTNISRCTN71917916
- Date ISRCTN created27-feb-2007
- date ISRCTN requested18-nov-2005
- Date Registered NTR12-sep-2005
- Secondary IDsN/A 
- Public TitleThe implementation of microarrays in cancer diagnosis (Microarray prognostics in breast cancer).
- Scientific TitlemRNA expression patterns as an aid in adjuvant systemic therapy decision making in lymph node negative breast cancer patients.
- ACRONYMRASTER
- hypothesisHypothesis: The implementation of microarray diagnostics is feasible in general practice in community hospitals.
- Healt Condition(s) or Problem(s) studiedBreast cancer
- Inclusion criteriaFemale patients with primary operable unifocal breast cancer without clinical signs of lymph node involvement or distant metastasis younger than 55 years of age.
- Exclusion criteriaA prior history of any malignancy with the exception of cervical dysplasia and basal cell carcinoma.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeintervention
- planned startdate 22-jan-2004
- planned closingdate31-dec-2006
- Target number of participants750
- InterventionsDiagnostic intervention with the 70-gene microarray profile giving a result of 'high' or 'low' risk for distant metastasis and death.
- Primary outcomeThe amount of succesfully performed diagnostic microarray tests as a proportion of the total number of accrued patients.
- Secondary outcome1. 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).
- Timepoints
- Trial web sitehttp://www.microarrays.nl/www.raster-nki.nl
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDr. S.C. Linn
- CONTACT for SCIENTIFIC QUERIESDr. S.C. Linn
- Sponsor/Initiator Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL)
- Funding
(Source(s) of Monetary or Material Support)
Dutch Health Care Insurance Board (CVZ, independent governement organisation), Agendia BV, Amsterdam
- PublicationsN/A
- Brief summaryRecently 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 (van ‘t Veer et al., Nature 2002; Van de Vijver et al., New Engl J Med 2002). To assess whether this 70-gene microarray test can be implemented in daily clinical practice we aimed to answer the following three questions: I. Is it feasible to collect fresh tumor samples in order to make this test available in pN0 breast cancer patients in community hospitals? II. What is the proportion of a ‘high’ versus a ‘low’ risk profile in node negative patients? III. 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, tumor grade, hormonal receptor-status)? A selected number of community hospitals, all different in their logistics and/or size are participating in this trial. Fresh tumor tissue samples of eligible patients will be collected within one hour after surgery and sent in RNAlater® to our hospital. A 70-gene microarray test will be performed in node negative patients with a representative tumor tissue sample; pN+ patients will be excluded. According to current Dutch guidelines (used for guiding adjuvant systemic treatment) for node negative patients, high risk is defined as age < 35 years, pT any size and grade 2-3 or pT > 1cm and grade 1, or age > 35 years, pT1-2 cm and grade 3, pT2-3cm and grade 2-3 or pT>3cm and any grade; all others are defined as low risk. After surgery, clinical decision making regarding adjuvant systemic treatment will initially be based on Dutch guidelines. After communication of the 70-gene microarray risk profile, changes in clinical decision making will be monitored. This study will show us whether the use of this kind of microarray diagnostics is feasible in daily clinical practice.
- Main changes (audit trail)
- RECORD12-sep-2005 - 2-sep-2009


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