The implementation of microarrays in cancer diagnosis (microarray prognostics in breast cancer)
| ISRCTN | ISRCTN71917916 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71917916 |
- Submission date
- 27/02/2007
- Registration date
- 27/02/2007
- Last edited
- 27/09/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr S C Linn
Scientific
Scientific
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL)
Plesmanlaan 121
Amsterdam
1066 CX
Netherlands
| Phone | +31 (0)20 512 2951 |
|---|---|
| s.linn@nki.nl |
Study information
| Study design | Non-randomised, non-controlled, diagnostic multicentre clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Multi-centre |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Scientific title | The implementation of microarrays in cancer diagnosis (microarray prognostics in breast cancer) |
| Study acronym | RASTER |
| Study objectives | 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(s) | Approval received from the local ethics committee (Protocol Toetsingscommissie) on the 8th October 2003 (study ref: MO3ARR; letter ref: EV03-464). |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 22/01/2004 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 750 |
| Key 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 |
| Key exclusion criteria | A prior history of any malignancy with the exception of cervical dysplasia and basal cell carcinoma. |
| Date of first enrolment | 22/01/2004 |
| Date of final enrolment | 31/12/2006 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL)
Amsterdam
1066 CX
Netherlands
1066 CX
Netherlands
Sponsor information
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL) (The Netherlands)
Charity
Charity
Plesmanlaan 121
Amsterdam
1066 CX
Netherlands
| Website | http://www.nki.nl/ |
|---|---|
"ROR" |
https://ror.org/03xqtf034 |
Funders
Funder type
Industry
Dutch Health Care Insurance Board (CVZ) (The Netherlands) - independent government organisation
No information available
Agendia B.V. (The Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2007 | Yes | No | |
| Results article | results | 01/09/2011 | Yes | No | |
| Results article | 10 year follow up | 17/09/2022 | 27/09/2022 | Yes | No |
