METEL Study Which is to Collect Urine Samples From Patients to Analyse Their Chemistry to Assess How Close to Death the Patient is at Point of Sample When They Have a Solid Cancer Tumour Diagnosis (METEL)

Metabolic Changes at End of Life

Use of samples from patients with solid cancer tumour diagnosis to assess chemistry

Study Overview

Status

Recruiting

Conditions

Detailed Description

We do not know how people die from cancer. In the last two weeks of life, there is evidence for deranged respiratory and renal function variables (2), although few patients have evidence of organ failure. Pulmonary embolus and infection are thought to be the major causes of death based on post-mortem studies (3, 4). However, it is unusual for people with cancer to die suddenly as anticipated from a pulmonary embolus. About a third of patients with advanced cancer admitted to specialist palliative care units have a femoral deep vein thrombosis. Therefore, thromboembolism is considered a manifestation of advanced disease, rather than a cause of premature death (5). There is also a difference between the physiological deterioration leading to death in the acutely unwell patient compared to people dying from cancer (2); there is no evidence of sepsis in those with cancer (6).

This suggests cancer patients generally do not die from organ failure and in those that die with an infection or pulmonary embolus; they die with them, rather than from these events.

A systematic review of biomarkers associated with dying identified common themes in cancer patients, irrespective of the type of malignancy: systemic inflammation, haematological changes, cachexia, hepatic dysfunction, renal dysfunction, and electrolyte changes. (7). Given the common features shared in patients dying from cancer, a "dying process" has been proposed (7) but has not yet been described.

Study Type

Observational

Enrollment (Estimated)

1327

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

    • Merseyside
      • Liverpool, Merseyside, United Kingdom, L7 8YA
        • Recruiting
        • Clatterbridge Cancer Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with a solid tumour cancer diagnosis

Description

Inclusion Criteria:

  • Must have as solid cancer tumour diagnosis Must be over the age of 18 Must be able to understand and communicate in English Must be able to provide fully informed consent at the point of trial entry Must be able to urinate freely or be catheterised

Exclusion Criteria:

  • Does not have a solid cancer tumour diagnosis Under the age of 18 Unable to communicate and understand English Unable to provide fully informed consent at the point of trial entry Is no cathetherised or able to urinate freely

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: CASE_ONLY
  • Time Perspectives: PROSPECTIVE

Cohorts and Interventions

Group / Cohort
Solid Tumour Cancer

Solid Tumour Cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Study Outcome
Time Frame: 18 months

This work could identify mechanisms involved in the dying process and develop test predicting time until death.

Understanding of the biology of dying will improve the recognition of people in the last days and weeks of life. This will; - - Improve the quality of a person's death by reducing uncertainty and facilitating preferred place of care.

Reduce healthcare spending on futile diagnostic and therapeutic interventions. We will correct urine samples once per week from participants, to be able to analyse their metabolites for changes towards end of life.

18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2026

Primary Completion (Estimated)

February 28, 2028

Study Completion (Estimated)

February 28, 2028

Study Registration Dates

First Submitted

September 7, 2026

First Submitted That Met QC Criteria

September 29, 2026

First Posted (Actual)

September 30, 2026

Study Record Updates

Last Update Posted (Actual)

September 30, 2026

Last Update Submitted That Met QC Criteria

September 29, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 337603
  • 337603 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.