NCT04682665Completed
Prebiotic Effect of Eicosapentaenoic Acid Treatment for Colorectal Cancer Liver Metastases
Biospecimen Collection for:Prebiotic Effect of Eicosapentaenoic Acid Treatment for Colorectal Cancer Liver Metastases
Source: ClinicalTrials.gov · Last updated 4 Dec 2024
Brief summary (registry, in English)
A significant proportion of patients who undergo liver surgery to remove bowel cancer that has spread to the liver (metastases) develop disease recurrence and die from the disease. The EMT2 study (NCT03428477) is a clinical trial of the omega-3 fatty acid EPA, investigating whether patients who EPA ethyl ester remain free of disease recurrence for longer than those taking placebo. Recent data suggest that the anti-cancer effect of EPA may result from changes to the microbiota (gut bacteria) which lead to an improved anti-cancer response by the immune system. This study will collect biospecimens (stool, urine, blood, tumour tissue) from participants in the EMT2 trial in order to interrogate the microbiome and immune mechanisms associated with EPA treatment, in relation to participant survival. Insights from this study will identify those most likely to benefit from treatment, leading to more targeted, personalised use of EPA.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 81 (actual)
- First submitted
- 2 Dec 2020
- Start date
- 16 Sept 2021
- Primary completion date
- 31 Jul 2024
- Lead sponsor
- University of Leeds
- Diseases
- Colorectal cancer
- NCT number
- NCT04682665
What you commit to
- Study type: Observational
- Participants enrolled: 81
- From 16 Sept 2021 to the primary completion date, 31 Jul 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- There are NO exclusions for entry to the biospecimen collection study if an individual has already been recruited to the EMT2 trial.
Who the study is looking for
- Only individuals who have already been enrolled in the EMT2 trial are eligible for inclusion in the biospecimen collection study.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| St James's University Hospital Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| University of Liverpool Coordinator of this site? Confirm its status | Liverpool | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.