Study Design: Randomised Controlled Trial
Disease Area: Cancer / Breast Cancer
Funder: Genomic Health, Inc
Sponsor: Newcastle Hospitals NHS Foundation Trust
Chief Investigator: Mr Henry Cain
Trial Registration: ISRCTN14337451
Pre-operative Oncotype Dx testing – A Decision Impact Study (PRE-DX)
Summary
Currently, cancer treatment plans follow a standard pathway that use biopsy samples taken during surgery to support doctors to be able to make the best decisions about how to treat their patients going forwards. These biopsy samples are tested using a test called Oncotype DX.
Oncotype Dx is a prognostic and predictive genomic assay, validated and approved for use in early Oestrogen receptor positive (ER+) breast cancer to guide adjuvant treatment choices (chemotherapy, radiotherapy or endocrine therapy).
This multi-centre prospective randomised controlled trial (RCT) aims to see whether testing the biopsy sample taken at the time of diagnosis (rather than at surgery) can help doctors to plan your cancer treatment.
What we plan to do
We will invite 330 patients newly diagnosed with breast cancer to participate in the study from 20 different hospitals around the UK. 110 patients will be randomised to the standard arm (biopsy test done at surgery) and 220 patients to the intervention arm (biopsy test done at diagnosis).
There will be no change to other standard pre-operative investigations or clinics.In both arms of the study, the interpretation of the test results and future treatment recommendations will be at the discretion of the multidisciplinary team and treating clinicians according to national guidelines.
Patients will be asked to complete questionnaires about their mental wellbeing and health service utilisation at various point during the study recruitment and follow up period.
Chief Investigator
Henry Cain Consultant Oncoplastic Breast Surgeon - Royal Victoria Infirmary, Newcastle Upon Tyne
HHTU Study team
Dr Matthew Northgraves - Trial Manager
Paul Bradley - Trial Co-ordinator
Sarah Sumpter - Data Manager
Dr Chao Huang - Statistician
Prof Judith Cohen - Co-applicant
Amy Porter - Trial Administrator
John Turgoose - Information Systems Manager
Collaborators
James Harvey Consultant Oncoplastic Breast Surgeon - Manchester University NHS Foundation Trust
Carlo Palmieri Consultant Medical Oncologist - The Clatterbridge Cancer Centre NHS Foundation Trust
Sarah Pinder Consultant Breast Pathologist - Guy's and St Thomas' NHS Foundation Trust
Sarah Reynia Medical Director - Exact Sciences
PG Roy Consultant Oncoplastic and Reconstructive Breast Surgeon - Oxford University Hospitals NHS Foundation Trust
Email Address
pre-dx@hyms.ac.uk
Participating sites and their Project Investigators
- Newcastle Upon Tyne Hospitals NHS Foundation Trust Robert Thomas
- Liverpool University Hospitals NHS Foundation Trust Julia Henderson
- Aneurin Bevin University Health Board Valentina Lefemine
- Oxford University Hospitals NHS Foundation Trust Pankaj Gupta Roy
- North Tees and Hartlepool Hospitals NHS Foundation Trust Matei Dordea
- Gateshead Health NHS Foundation Trust Robert Milligan
- Chesterfield Royal Hospital NHS Foundation Trust Ciaran Hollywood
- Shrewsbury and Telford Hospital NHS Foundation Trust Laura Pettit
- Mid & South Essex NHS Foundation Trust Gill Clayton
- Hywal Dda University Health Board Saira Khawaja
- Airedale NHS Foundation Trust Claire Murphy
- North Cumbria Integrated Care NHS Foundation Trust Jane Ralph
- NHS Grampion Ehab Hussain
- Nottingham University Hospitals NHS Trust Hazem Khout
- Hull University Teaching Hospitals NHS Foundation Trust Dorin Dumitru
- Mid Yorkshire Teaching NHS Trust Daniel Glassman
- Wirral University Teaching Hospitals NHS Foundation Trust Raman Vinayagam
Conference presentations
Harris, G., Northgraves, M., Cohen, J., Harvey, J., Huang, C., Palmieri, C., Pinder, S., Roy, P., Reynia, S., & Cain, H. (2023). Study in progress - Pre-operative Oncotype DX testing: A decision impact study (PRE-DX). European Journal of Surgical Oncology, 49(5), e245. https://doi.org/10.1016/j.ejso.2023.03.112
Harris, G., Northgraves, M., Cohen, J., Huang, C., Roy, P., Reynia, S., & Cain, H. J. (2023). 151TiP Study in progress - Pre-operative genomic assay testing: A decision impact study (PRE-DX). ESMO Open, 8(1, Supplement 4), 101490. https://doi.org/https://doi.org/10.1016/j.esmoop.2023.101490