Exploiting the Gut Microbiota and Its Metabolites in Pelvic Cancer

NCT05605353 | Recruiting

• 1 other identifier: 2-066-22
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pelvic Neoplasm

Outcome Measures

Primary Outcomes (1)

• 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

  18 month recruitment

Secondary Outcomes (1)

• Are there differences in the gut microbiota between urological, colorectal and gynaecological cancers?

  18 month recruitment

Study Arms (3)

Colorectal

Patients with rectal or colon cancer

Diagnostic Test: Faecal microbiota sampling and blood sampling

Gynaecological

Patients with uterine, ovarian or cervical cancers

Diagnostic Test: Faecal microbiota sampling and blood sampling

Urological

Patients with bladder or prostate cancers

Diagnostic Test: Faecal microbiota sampling and blood sampling

Interventions

Faecal microbiota sampling and blood sampling DIAGNOSTIC_TEST

There 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

Colorectal; Gynaecological; Urological

Eligibility Criteria

• Age: 16 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

450 patients who have been diagnosed with pelvic neoplasms in the NHS Grampian region of Scotland, United Kingdom

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aberdeen: lead

Study Sites (1)

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

We will undertake 16srRNA gene sequencing of the bacterial DNA, metabolite and Short Chain fatty acid analysis from the blood and faecal samples (taken from the right colon at the time of the operation). Comparisons between these microbial analysis will then be undertaken in a pair-wise approach.

MeSH Terms

Conditions

Pelvic Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• George Ramsay, FRCS

  University of Aberdeen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

George Ramsay, FRCS

CONTACT

03454566000; george.ramsay@abdn.ac.uk

Study Design

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

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: November 4, 2022
• Study Start: March 1, 2023
• Primary Completion: May 31, 2024
• Study Completion (Estimated): May 31, 2029
• Last Updated: May 16, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)