About this trial
The large intestine is the last part of the digestive tract. It absorbs water and dietary substances. However, it is also where most of our bacteria are resident. These bacteria are important for our health and influence many different diseases, including Colon Cancer, Ulcerative Colitis and Crohn's disease. The gut bacteria can also potentially influence responses to treatments in other cancers by helping to change the responses to radiotherapy and chemotherapy. The interactions between these bacteria and the rest of our cells are only now becoming understood and there is little research on the interactions between these bacteria and cancer radiotherapy treatments in pelvic cancer.
We will therefore explore this in more detail. We will ask for samples of the patient's poo before their treatment for pelvic cancers. This will include patients with bladder, prostate, cervical, ovarian, womb or colorectal cancers. By doing so we will be able to compare the profile of gut bacteria with responses to treatments, thereby increasing our understanding of the colonic bacteria.
To do this we process the poo specimens to remove the bacterial genetic material (DNA) of the bacteria and process it on a machine to read the genetic code and also study the metabolites that they will produce. We can then make a direct comparison between different samples of the relative numbers of different bacteria present. In some cases, we will compare this to metabolites and inflammatory and immune markers identified in a blood sample. This work might help future patients by determining what are the best bacteria to have in the colon during cancer treatments. These could potentially be given to patients, before their cancer treatment, in the form of probiotic medications, should there be an improvement demonstrated in our research. Alternatively we could alter the patients' intakes of specific dietary fibres to boost these bacteria specifically.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients willing to consent
Any patient who is being treated in NHS Grampian for a pelvic cancer (Colorectal, urological or gynaecological) above 16 years of age
Disqualifiers
patients who are not willing to consent to be involved
Malignancies from other sources or anatomical locations
Patients who lack the understanding of the study to obtain appropriate levels of consen
Trial population
450 patients who have been diagnosed with pelvic neoplasms in the NHS Grampian region of Scotland, United Kingdom
Trial design
Cohort
Prospective
Treatments tested in this trial
Faecal microbiota sampling and blood sampling
Diagnostic testThere is no intervention in this study. We will obtain faeces and blood from the recruited patients and assess the microbiota and their metabolites therein. This is an observational work
Treatment groups
Trial outcomes
Primary outcomes
Correlation between microbial analysis and response to cancer therapy
To assess if key microbes (analysed by pyrosequencing), or their metabolic byproducts (analysed by short chain fatty acid identification) detect for positive or adverse response to conventional therapy and cancer outcomes
Secondary outcomes
Are there differences in the gut microbiota between urological, colorectal and gynaecological cancers?
16srRNA pyrosequencing and short chain fatty acid analysis will be undertaken for patients with the three cancer groupings. These data will be compared against each other to assess similarity or differences in the faecal microbial flora between the conditions.
Sponsors and contacts
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