REQUITE study

Goal

In recent years predictive models have been developed that attempt to identify, before the start of radiotherapy, 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. The goal of the REQUITE project is to validate known predictors of adverse reactions after radiotherapy to  develop statistical models to become clinically useful.

Background

Approximately half of all cancer patients receive radiotherapy as part of their cancer treatment. The dose of radiation given is limited because of a risk of damaging the normal tissues and organs that surround the tumour. Patients vary in how they react to radiation. About 5% of patients (5 out of every 100) are sensitive and at risk of having side effects. In recent years, researchers have developed predictive models and biological tests to try to identify before the start of treatment those patients who are very sensitive. However, these methods are not yet ready to use in the clinic so radiation doses for all patients are currently limited by the risk of side effects in the most sensitive patients.

Methods

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.

The study is being organized by the University of Manchester together with the DKFZ and will be conducted with several hospitals in Belgium, France, Italy, The Netherlands, Spain, UK, USA and Germany (Rhein-Neckar area, Karlsruhe and Frankfurt).

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