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NCT05605353
Exploiting the Gut Microbiota and Its Metabolites in Pelvic Cancer
trial testing Faecal microbiota sampling and blood sampling in Pelvic Neoplasm in 450 participants. Currently enrolling.
31 May 2024
Quick facts
| Lead sponsor | University of Aberdeen |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 450 |
| Start date | 1 March 2023 |
| Primary completion | 31 May 2024 |
| Estimated completion | 31 May 2029 |
| Sites | 1 location across United Kingdom |
Drugs / interventions tested
- Faecal microbiota sampling and blood sampling
Conditions studied
- Pelvic Neoplasm — all drugs for Pelvic Neoplasm →
Sponsor
University of Aberdeen
Who can join
Adults 16 to 99, any sex, with Pelvic Neoplasm. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05605353 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Aberdeen
- Last refreshed: 16 May 2023
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing