The PREDICT Study
Research type
Research Study
Full title
Using an electronic nose to predict gastrointestinal consequences of pelvic radiotherapy
IRAS ID
159187
Contact name
Alexandra Taylor
Contact email
Sponsor organisation
The Royal Marsden NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 11 months, 30 days
Research summary
Scientists have developed an instrument which works like an “electronic nose”. It is able to “sniff” smells and separate different smells by their electronic “signature”. Studies using an electronic nose strongly suggest that smelling samples taken from humans (eg urine/ stool/ sweat/ tears) can identify different electronic smell signature from people with different diseases and in the future might be a new and easier way to diagnose serious conditions at an earlier stage.
In a very small study, we showed that using an electronic nose to sniff a stool sample does seem to identify people - before they have had any radiotherapy – who will go on to get serious bowel side effects of radiotherapy. If this finding is correct, this is very important as it would allow the cancer doctors the option to change the way they give radiotherapy if they knew that a person was at very high risk of serious side effects from the treatment and to start treatment for the side effects at a much earlier stage.
In this study we want to confirm in a larger study whether our previous findings are correct, see whether we get the same result by sniffing urine rather than stool (that would be much easier for everyone) and identify exactly which part of the complicated “smell” signature is different in the people who will get side effects. If we know this, we might be able to identify why people are making this specific smell and then do something about changing the smell before treatment starts. The likeliest cause for the production of a smell which predisposes to side effects is a specific group of germs living in the bowel. If we can identify which germs these are, there are many possible ways of changing these germ populations in advance of radiotherapy.
Enormous improvements have made in treating cancer in recent years leading to hugely improved survival, however, treatment not infrequently can lead to side effects. Of all the possible long term physical side-effects of cancer treatment, gastrointestinal (GI) symptoms are the most common and can have a great impact on daily activity. It is becoming increasingly clear that development of side effects in the bowel is not just related to the dose and way the radiotherapy is delivered. An important finding in this field is the role of bacteria that live in our guts (called microbiota). The gastrointestinal microbiota are very important in keeping us well. Up to 1,000 bacterial types will be found in any one individual. The species vary greatly between individuals but for each individual person, the type of bacteria which are living in their bowels remains largely the same over time. We already know that the variability in the types of bacteria is high in healthy people and much lower in people with GI side effects after pelvic radiotherapy. So this very simple study has a good chance of significantly improving our ability to help people avoid side effects of radiotherapy in the future.
REC name
London - Dulwich Research Ethics Committee
REC reference
15/LO/0436
Date of REC Opinion
1 May 2015
REC opinion
Further Information Favourable Opinion