Oncotype DX DCIS: Impact on clinical decision making
Research type
Research Study
Full title
A study assessing the impact of the Oncotype DX DCIS score on radiotherapy decision making in the United Kingdom
IRAS ID
249065
Contact name
Nicola Roche
Contact email
Sponsor organisation
Royal Marsden Hospital
Duration of Study in the UK
4 years, 11 months, 26 days
Research summary
This study involves patients diagnosed with ductal carcinoma in-situ (DCIS) treated by breast conserving surgery (BCS). After surgery, most patients are recommended radiotherapy (RT)to the whole breast to reduce the chance of the DCIS coming back. However, some patients may have a very low chance of DCIS coming back, and may be able to avoid RT. In order to determine the risk of recurrence and benefit of RT many factors are considered. These include patient age, DCIS size, how close the DCIS is to the edge of the removed breast tissue and how aggressive the DCIS looks under the microscope. RT has short and long-term side effects such as changes to the appearance and texture of the breast and the very small risk of lung and cardiac toxicity. Moreover, there is the risk of inducing second cnacers, especially in smokers. Ideally, we should be able to accurately predict an individual's risk of recurrence so that the benefit of RT can be weighed up against the potential risk of side effects.
A recent test called the ‘Oncotype DX DCIS’ test can be performed on the DCIS that is removed at surgery. It tests DCIS for the activity of specific genes, and uses this to predict how likely it is that the disease will come back in the future, either as DCIS or invasive cancer. This study is offering patients the Oncotype DX DCIS test. We want to study whether having this test changes the doctor’s recommendation on whether or not patients should have RT. We also want to study whether it changes patients' minds on whether or not they would like to have RT, and how comfortable they feel with their decision.
REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
19/YH/0209
Date of REC Opinion
4 Jul 2019
REC opinion
Favourable Opinion