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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
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

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
St James's University Hospital
Coordinator of this site? Confirm its status
LeedsUnited KingdomUnknown status
University of Liverpool
Coordinator of this site? Confirm its status
LiverpoolUnited KingdomUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.