PReCISE Pilot
Research type
Research Study
Full title
PReCISE: ‘Predicting, Recording and Reducing Chemotherapy Induced Side Effects’: A pilot feasibility study of both a new germline genetic test for risk of toxicity with fluoropyrimidine-based chemotherapy (ColoTox), and of a digital application to monitor and record associated toxicities (PROMinet)
IRAS ID
173762
Contact name
Rachel Kerr
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
This pilot study will assess the utility of two novel tools in the management of colorectal cancer (CRC): Firstly we will pilot the Colotox test, a simple blood test which can identify patients most at risk of chemotherapy induced side effects before treatment commences and may allow dose reductions preventing high grade side effects; secondly we will pilot PROMinet, a new mobile phone App which can accurately record side effects in real time in patients undergoing fluoropyrimidine-based CRC chemotherapy, ie. inclusive of the drugs capecitabine or 5-fluouracil, which comprise the standard backbone of all CRC chemotherapy regimens.
The ColoTox test involves the taking about 10mls of blood from a patient and looking at that individual's genetic sequences in order to predict the potential risk of serious toxicity from the chemotherapy, thus potentially allowing clinicians to select a lower starting dose, reducing the severity side effects (and even preventing toxic-related death) in susceptible patients.
PROMinet is an App designed for mobile devices that collects patient reported outcome measures (PROMs) in chemotherapy patients, allowing clearer identification of timing and severity of side effects related to chemotherapy.
We hope to recruit 100 patients with CRC who will undergo chemotherapy and offer all of them the ColoTox test prior to starting treatment, and the PROMinet app to record side effects during the course of their treatment.
The clinical utility of the ColoTox test will be based on whether clinicians altered their treatment decisions and made dose reductions upon receipt of the ColoTox results and the frequency and duration of any side-effects and emergency admissions during chemotherapy. The practical usefulness of the PROMinet app will be assessed based on patient and clinician reported qualitative outcomes on the user-friendliness of the application, its technical performance, and the usefulness of data it collects.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
16/LO/0915
Date of REC Opinion
17 Aug 2016
REC opinion
Further Information Favourable Opinion