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Routine Evaluation of People Living With Cancer (REVOLUTION)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04406662
Recruitment Status : Recruiting
First Posted : May 28, 2020
Last Update Posted : April 28, 2021
Sponsor:
Collaborator:
NHS Lothian
Information provided by (Responsible Party):
University of Edinburgh

Brief 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.


Condition or disease
Cachexia; Cancer Advanced Cancer Quality of Life

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Routine Evaluation of People Living With Cancer - Body Composition, Physical Function, Systemic Inflammatory Response, Quality of Life and Symptoms
Actual Study Start Date : July 15, 2020
Estimated Primary Completion Date : August 8, 2029
Estimated Study Completion Date : August 8, 2029



Primary Outcome Measures :
  1. Association between inflammatory cytokines and clinical parameters in incurable cancer [ Time Frame: 2 years ]
    Correlation of serum levels of inflammatory cytokines with clinical parameters including skeletal muscle mass, symptom based scores and physical activity as measured by actigraphy.


Biospecimen Retention:   Samples With DNA

Blood samples - samples sent for routine inflammatory markers, plasma retained for analysis of cytokine levels and stored in a biobank for use in future ethically approved studies including potential genetic DNA analysis.

Archival tissue specimens (including fresh frozen and/or formalin fixed paraffin embedded biopsy/surgical specimens) that are no longer required by the local pathologist for diagnostic purposes, or are stored as part of ethically approved tissue collection/research studies, may be requested from patients in the course of establishing the biobank for further analysis in future studies



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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
Criteria

Inclusion Criteria:

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04406662


Contacts
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Contact: Barry JA Laird, MBCHB MD 01316518611 barry.laird@ed.ac.uk

Locations
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United Kingdom
St Columba's Hospice Recruiting
Edinburgh, United Kingdom, EH53RW
Contact: Rebekah Patton    01315511381    rpatton@stcolumbashospice.org.uk   
Sponsors and Collaborators
University of Edinburgh
NHS Lothian
Investigators
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Principal Investigator: Barry JA Laird, MBCHB MD St Columba's Hospice/ University of Edinburgh
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Edinburgh
ClinicalTrials.gov Identifier: NCT04406662    
Other Study ID Numbers: AC19154
First Posted: May 28, 2020    Key Record Dates
Last Update Posted: April 28, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Edinburgh:
cancer
advanced cancer
incurable cancer
body composition
physical function
symptoms
cachexia
quality of life
systemic inflammatory response
palliative medicine
Additional relevant MeSH terms:
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Wasting Syndrome
Cachexia
Emaciation
Weight Loss
Body Weight Changes
Body Weight
Metabolic Diseases
Nutrition Disorders