About this study
The goal of the REQUITE project is to validate known predictors of adverse reactions and develop the statistical models to become clinically useful.In recent years predictive models have been developed that attempt to identify before the start of treatment patients at risk of long-term side-effects. These emerging models require systematic validation in a multi-centre collaborative setting. There are an increasing number of datasets available for validation but they are variable in terms of the data collected.
This multi-centre observational study will be the largest study of its kind collecting blood samples and standardised data longitudinally from 5,300 cancer patients. It will enable validation of models that predict a patient’s risk of developing long-term side-effects following radiotherapy. It will be a unique (eventually widely accessible) resource for studying the relationships between side-effect endpoints and between side-effects and quality-of-life. It is known that genetics influence a patient’s risk of developing side-effects and a number of assays/approaches have been explored to assess a patient’s sensitivity to radiation. This prospective observational study will allow for the validation of the most promising biomarkers/approaches.
Figure 1 presents an overview of the objectives of this study.
Fifteen partners are working together to collect blood samples and standardised data longitudinally from patients with breast, prostate and lung cancer. The REQUITE project will develop and validate statistical models incorporating biomarker data to predict radiotherapy adverse reactions. Future interventional trials will use these models to help optimise radiotherapy. ISRCTN trial registration.
Start project: October 2013
Start recruitment: April 2014
Finish recruitment: Septembre 2016 for breast and prostate, March 2017 for lung
Follow-up ends: March 2018
End project: September 2018
Figure 2 presents the workflow of this study.
For a description of the Work packages (1-7), study documentations and information about questionniare development, see the links below.