PINPOINT accuracy study
Research type
Research Study
Full title
A diagnostic accuracy study of PINPOINT blood sample analysis in detecting cancer
IRAS ID
311006
Contact name
James Turvill
Contact email
Sponsor organisation
York and Scarborough Teaching Hospitals NHS Foundation Trust
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
The study will look at the diagnostic accuracy of the PinPoint test, a machine learning algorithm that uses a range of blood results combined with basic patient information to provide a patient risk score for cancer. Many of these tests are routinely requested as part of the referral pathway and where possible for phase 1 and 2 residual blood and plasma samples would be used for any further tests required.
The study will be a staged study, phases 1 and 2 will run alongside each other to determine the accuracy of the test in the various fast track cancer diagnosis pathways. These two phases would be observational only to determine the accuracy of the test. Results will only be available to the research team to avoid any confusion with the current patient pathway. However the results will be reviewed by a member of the care team from York Hospital and if there are any significantly abnormal results it will be fed back to the GP for information.
Phase 3 will depend upon positive outcomes from phase 1 and/or 2. It will see the test rolled out as part of the referral pathway. Results from the tests will be made available and provide a risk assessment for the GP, either "high risk: suggest 2ww referral" or "low risk: suggest primary care management". The GP will then elect to manage the patient in line with this guidance or override this assessment based on their own clinical judgement. Clinical outcomes will be recorded and the diagnostic accuracy of the PinPoint algorithm as an intervention will be established.
REC name
South West - Frenchay Research Ethics Committee
REC reference
22/SW/0044
Date of REC Opinion
4 May 2022
REC opinion
Further Information Favourable Opinion