RanDx - a test for breast cancer recurrence and metastasis
Research type
Research Study
Full title
RanDx - An affordable highly sensitive predictive test for breast cancer recurrence and metastasis
IRAS ID
325814
Contact name
Chris Twelves
Contact email
Sponsor organisation
Head of Regulatory Compliance, The Secretariat, University of Leeds
Duration of Study in the UK
1 years, 2 months, 31 days
Research summary
Breast cancer is the most commonly diagnosed cancer in the UK with ~1,000 women dying/month from secondary/metastatic disease. The commonest sub-type (70%) is HR (hormone receptor) positive, HER2 negative.
When women are first diagnosed, initial treatment is usually with surgery +/- radiotherapy. Doctors then estimate the individual risk of developing metastatic cancer in the future. Higher risk patients are recommended to receive chemotherapy, further reducing the risk of their cancer returning. Chemotherapy has, however,
unpleasant side effects and not all patients benefit.NHS doctors can request the "Oncotype DX" test, which looks at the genes in a patient's breast cancer and identifies those women more likely to benefit from chemotherapy. For this the cancer samples are sent to a specialist laboratory abroad. Oncotype Dx is available to UK and NHS patients, but not for women in
many low/middle income countries because of its cost.We have developed RanDx, a new test that may be rapidly performed using existing equipment in NHS pathology laboratories. The RanDx test could save the NHS ~£65m/year and be accessible to patients in many more countries. We have already shown that RanDx distinguishes between women at high and low risk of later developing metastatic disease. Now we need to test whether RanDx and Oncotype Dx give equivalent results.
To do this we will identify 600 patients whose breast cancers already have had the Oncotype Dx test and re-test their original tumour samples using RanDx to give two scores for each patient that we can compare. If the scores are equivalent, the data will be utilised for further development of RanDx.
This application for ethical approval is to use existing tissue samples and anonymised patient data to demonstrate RanDx equivalence with Oncotype Dx (as described in the protocol). Any future resulting work packages will be subject to their own regulatory and ethical approvals.
REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
24/YH/0038
Date of REC Opinion
14 Mar 2024
REC opinion
Favourable Opinion