ClinicalTrials.gg
RecruitingNCT04406662REVOLUTIONUpdated Jul 7, 2026

Routine Evaluation of People Living With Cancer

An observational study in Cachexia; Cancer, Advanced Cancer and Quality of Life, sponsored by University of Edinburgh. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by University of Edinburgh · Observational

From the registry’s dates

  • Started Jul 2020; still recruiting 6 years 3 months later.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
600
Ages
18 Years and older
Sex
All
01

Study summary

People with incurable cancer often have complex individual needs, however there are several common themes encountered when considering this group.

As cancer progresses there are series of interactions between the tumour and the patient, producing both local and systemic effects. This altered state of illness can have multiple ill effects including weight loss, fatigue, increased symptom burden and reduction in physical function which all contribute to a reduced quality of life.

These areas are often studied in isolation, giving an incomplete picture. A detailed, holistic characterisation of this group of people does not exist.

A robust characterisation of people with incurable cancer will allow identification and prioritisation of future research and has the potential to inform new therapeutics and provide justification for treatments.

This study aims to collect information about symptoms and quality of life, weight loss and body composition, physical activity and the body's immune response to cancer.

Participants with incurable cancer will be recruited to the study from oncology and palliative medicine services in the UK. Participants will answer questionnaires about quality of life and symptoms, have bloods taken for inflammatory marker and cytokine analysis and have their body composition measured by a variety of methods.

02

Conditions studied

  • Cachexia; Cancer
  • Advanced Cancer
  • Quality of Life

Keywords

  • cancer
  • advanced cancer
  • incurable cancer
  • body composition
  • physical function
  • symptoms
  • cachexia
  • quality of life
  • systemic inflammatory response
  • palliative medicine
03

In context

Cachexia

331 studies on the registry are indexed under Cachexia; 75 are open to participants now.

This study's planned enrollment of 600 is above the median of 150 across 88 observational studies indexed under Cachexia.

Browse Cachexia studies →

Lead sponsor

University of Edinburgh is the lead sponsor of 403 studies on the registry; 64 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

People living with incurable cancer recruited from oncology and palliative care services in the UK

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients with incurable cancer ( cancer (Clinical, histological, cytological or radiological evidence) or receiving anti-cancer therapy with palliative intent).
  • Aged 18-years and over
  • Written

Exclusion criteria

Exclusion Criteria:

  • Any concomitant medical or psychiatric problems which, in the opinion of the investigator, would increase the risk of complication for the participant and/or investigator.
  • Participants will not be able to take part in bio-impedance analysis if they have a pacemaker or implantable cardiac defibrillator.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
600 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna
06

What researchers measure

Primary outcomes

  1. Association between inflammatory cytokines and clinical parameters in incurable cancer

    Correlation of serum levels of inflammatory cytokines with clinical parameters including skeletal muscle mass, symptom based scores and physical activity as measured by actigraphy.

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • St Columba's Hospice
    Edinburgh, EH53RW, United Kingdom
    Recruiting
08

References and documents

Publications

  • Paval DR, Patton R, McDonald J, Skipworth RJE, Gallagher IJ, Laird BJ; Caledonian Cachexia Collaborative. A systematic review examining the relationship between cytokines and cachexia in incurable cancer. J Cachexia Sarcopenia Muscle. 2022 Apr;13(2):824-838. doi: 10.1002/jcsm.12912. Epub 2022 Jan 25. PubMed 35080147 ↗

Individual participant data

Plan to share: Yes

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2020 (actual). Primary completion is estimated for Aug 2029, 108 months after the start.

Of 38 observational studies under Cachexia, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 48. This study's planned 108 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 13, 2020
First posted
May 28, 2020
StartActual
Jul 15, 2020
Primary completionEst.
Aug 8, 2029
CompletionEst.
Aug 8, 2029
Last update
Jul 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04406662
Collaborators
NHS Lothian
Responsible party
Sponsor
First posted
May 28, 2020
Start date
Jul 15, 2020
Primary completion
Aug 8, 2029 (estimated)
Completion
Aug 8, 2029 (estimated)
Last update
Jul 7, 2026

Study contacts

Barry JA Laird, MBCHB MD
Contact
barry.laird@ed.ac.uk
01316518611
Barry JA Laird, MBCHB MD
principal investigator · St Columba's Hospice/ University of Edinburgh

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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