Cancer Clinical Trial
— PREDICTOfficial title:
Using an Electronic Nose to Predict Gastrointestinal Consequences of Pelvic Radiotherapy
Verified date | January 2018 |
Source | Royal Marsden NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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 (e.g. 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, it has been successfully shown 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 the investigators want to confirm in a larger study whether the previous
findings are correct, and to see whether similar results can be obtained 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. This
may lead for the investigators to 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 these germs can be identified, then there are many possible ways of
changing these germ populations in advance of radiotherapy.
Enormous improvements have been 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.
Status | Active, not recruiting |
Enrollment | 120 |
Est. completion date | October 2019 |
Est. primary completion date | January 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria - Patients aged 18 years or above able to give informed consent - Patients to be treated with radical, adjuvant or neo-adjuvant radiotherapy for a new diagnosis of a gynaecological cancer. - Ability of the patient to provide informed consent. Exclusion Criteria - Patients aged less than 18 years - Patients who are pregnant - Patients unable to give informed consent - Patients being treated privately - Patients due to have their post-treatment follow-up elsewhere in the country - Patients on studies with conflicting end-points |
Country | Name | City | State |
---|---|---|---|
United Kingdom | The Royal Marsden NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
Royal Marsden NHS Foundation Trust | University of Warwick |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Olfactory Signatures in patient sample | A 6 point difference in the olfactory signatures in different samples (rectal swab, stool sample,urine, sample saliva sample) between patients who develop severe toxicity* and those with no or minimal toxicity. | 24 months | |
Secondary | Changes in Bristol Stool Chart Parameters. | The Bristol stool chart categorizes the types of stool a person passes into 7 categories. It is a helpful tool to assess stool consistency in combination with other tools assessing GI symptoms, however it does not describe the severity of toxicity so no cut off values. | 24 months | |
Secondary | Changes in the scores of Inflammatory Bowel Questionnaire, | For IBDQ a higher score will indicate a better Quality of Life (QoL). A change in IBDQ will indicate the level of patients QoL over the study period. | 24 months |
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