PRE-DX Study
Research type
Research Study
Full title
Pre-Operative Oncotype DX testing: A decision impact study
IRAS ID
286636
Contact name
Christopher Price
Contact email
Sponsor organisation
Newcastle upon Tyne Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN14337451
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Current treatment of breast cancer patients follows a standard clinical care pathway where a core biopsy is taken during surgery. The core biopsy sample is tested using the Oncotype DX test which gives a Recurrence Score (RS) that clinicians can use to support the need for adjuvant treatments (radiotherapy and / or chemotherapy) in addition to surgery.
This study aims to assess the impact on patient management if the Oncotype DX test is requested on a biopsy sample taken at the time of diagnosis (intervention arm) as opposed to a sample obtained during surgery (control arm). The availability of the Oncotype DX RS score earlier in the clinical care pathway may streamline the pathway, reducing time to commencement of adjuvant cancer therapy, reducing demand on health care services and improving patient experience.
The study will recruit men and women with newly diagnosed breast cancer who are preparing to undergo treatment. The study will be opened in 20 centres across the UK, with the aim to recruit 330 patients to the study over a 8-month period.
REC name
London - Surrey Research Ethics Committee
REC reference
22/LO/0421
Date of REC Opinion
26 Jul 2022
REC opinion
Further Information Favourable Opinion