Using an Electronic Nose to Predict Gastrointestinal Consequences of Pelvic Radiotherapy

NCT02649491 | Unknown

• 1 other identifier: 4201
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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 (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

Cancer; Toxicity; Malignancy

Keywords

Radiotherapy; Chemotherapy; Metabonomics; Electronic Sensing; GI Toxicity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in Bristol Stool Chart Parameters.

  24 months

• Changes in the scores of Inflammatory Bowel Questionnaire,

  24 months

Interventions

Cohort Observation OTHER

Study participation will be offered to women, newly diagnosed with a gynecological malignancy who are due to be treated with pelvic radiotherapy.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Over 2 years we will recruit 120 patients undergoing radical radiotherapy for a new, histologically proven, gynaecological malignancy at the Royal Marsden Hospital. Patients will be followed up for 2 years after completion of radiotherapy.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• University of Warwick: collaborator

Study Sites (1)

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Patients will be asked to provide stool and urine samples and complete symptom assessment questionnaires at 6 time points: baseline (before treatment), 2 and 6 weeks after starting radiotherapy, 6 months after completion of radiotherapy and 12 and 24 months after completion of treatment. In addition, patients will be asked to provide a rectal swab and a saliva sample, which will be stored and potentially used at a later stage to characterize any differences in the microbial populations present. (Funding will be sought elsewhere to analyse these samples).

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jervoise Dr Andreyev, MA, Phd

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2015
• First Posted: January 7, 2016
• Study Start: November 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: October 1, 2019
• Last Updated: January 30, 2018

Record last verified: 2018-01

Locations

GB (1)