Clinical trial · Observational
Using an Electronic Nose to Predict Gastrointestinal Consequences of Pelvic Radiotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Malignancy | Malignant Neoplasm | ALIAS | 0.90 |
| Toxicity | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cohort Observation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Change in Olfactory Signatures in patient sample
- timeFrame
- 24 months
- description
- 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.
Secondary outcomes (2)
- measure
- Changes in Bristol Stool Chart Parameters.
- timeFrame
- 24 months
- description
- 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.
- measure
- Changes in the scores of Inflammatory Bowel Questionnaire,
- timeFrame
- 24 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available