Routine Evaluation of People Living With Cancer (REVOLUTION)
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|ClinicalTrials.gov Identifier: NCT04406662|
Recruitment Status : Recruiting
First Posted : May 28, 2020
Last Update Posted : April 28, 2021
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|
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|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|
- 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
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
|Contact: Barry JA Laird, MBCHB MDemail@example.com|
|St Columba's Hospice||Recruiting|
|Edinburgh, United Kingdom, EH53RW|
|Contact: Rebekah Patton 01315511381 firstname.lastname@example.org|
|Principal Investigator:||Barry JA Laird, MBCHB MD||St Columba's Hospice/ University of Edinburgh|