Outcome
Type |
Measure |
Description |
Time frame |
Safety issue |
Primary |
Longitudinal changes in weight |
Longitudinal changes in weight (kg) - combined with height (m) to report body mass index (BMI) (kg/m2) |
Measured at baseline, following completion of any neo-adjuvant anti-cancer therapy, 6 (+/- 2) weeks, 6 (+/- 1) months and 12 (+/- 1) months following surgical resection |
|
Primary |
Longitudinal changes in computed tomography (CT) body composition (muscle quantity) |
Longitudinal changes in cross-sectional area (cm2) and volume (cm3) of skeletal muscle and radiodensity of skeletal muscle, subcutaneous fat, visceral fat and intra-muscular adipose tissue. |
Measured at staging CT scan, at repeat scan following any neoadjuvant anti-cancer therapies and at follow-up scans following surgical resection / adjuvant anti-cancer therapies and other scans up to 1 year post surgical resection |
|
Primary |
Longitudinal changes in CT body composition (muscle radiodensity) |
Longitudinal changes in radiodensity (HU - Hounsfield units) of skeletal muscle |
Measured at staging CT scan, at repeat scan following any neoadjuvant anti-cancer therapies and at follow-up scans following surgical resection / adjuvant anti-cancer therapies and other scans up to 1 year post surgical resection |
|
Primary |
Longitudinal changes in CT body composition (fat quantity) |
Longitudinal changes in cross-sectional area (cm2) and volume (cm3) of subcutaneous and visceral adipose tissue |
Measured at staging CT scan, at repeat scan following any neoadjuvant anti-cancer therapies and at follow-up scans following surgical resection / adjuvant anti-cancer therapies and other scans up to 1 year post surgical resection |
|
Primary |
Longitudinal changes in CT body composition (fat radiodensity) |
Longitudinal changes in radiodensity (HU - Hounsfield units) of subcutaneous and visceral adipose tissue |
Measured at staging CT scan, at repeat scan following any neoadjuvant anti-cancer therapies and at follow-up scans following surgical resection / adjuvant anti-cancer therapies and other scans up to 1 year post surgical resection |
|
Primary |
Longitudinal changes in systemic inflammation |
Longitudinal changes in serum levels of pro-inflammatory cytokines and other markers of systemic inflammation |
Measured at baseline, following completion of any neo-adjuvant anti-cancer therapy, 6 (+/- 2) weeks, 6 (+/- 1) months and 12 (+/- 1) months following surgical resection |
|
Primary |
Longitudinal changes in physical activity |
A personal activity monitor (FitBit) will be worn for the next eight days to assess step count and time of physical activity |
Measured at baseline, following completion of any neo-adjuvant anti-cancer therapy, 6 (+/- 2) weeks, 6 (+/- 1) months and 12 (+/- 1) months following surgical resection |
|
Primary |
Longitudinal changes in muscle function |
The 'timed up and go' test will be assessed for all participants as an estimate of lower limb muscle function |
Measured at baseline, following completion of any neo-adjuvant anti-cancer therapy, 6 (+/- 2) weeks, 6 (+/- 1) months and 12 (+/- 1) months following surgical resection |
|
Primary |
Longitudinal changes in muscle strength |
Isometric knee extension will be assessed for patients undergoing a multiparametric MRI as an estimate of quadriceps strength. This will be done using a hand-held dynamometer. |
Measured at baseline, following completion of any neo-adjuvant anti-cancer therapy, 6 (+/- 2) weeks, 6 (+/- 1) months and 12 (+/- 1) months following surgical resection |
|
Primary |
Longitudinal changes in risk of nutritional deficit |
Patient Generated Subjective Global Assessment Short Form ('PG-SGA-SF') questionnaires will be used to assess symptom burden and quality of life measures, specifically regarding nutritional risk in catabolic conditions |
Measured at baseline, following completion of any neo-adjuvant anti-cancer therapy, 6 (+/- 2) weeks, 6 (+/- 1) months and 12 (+/- 1) months following surgical resection |
|
Primary |
Longitudinal changes in quality of life (physical, psychological and social function in patients with cancer) |
European Organisation For Research And Treatment Of Cancer Quality of Life Questionnaire C30 ('EORTC-QLQ-C30') questionnaires will be used to assess symptom burden and general quality of life |
Measured at baseline, following completion of any neo-adjuvant anti-cancer therapy, 6 (+/- 2) weeks, 6 (+/- 1) months and 12 (+/- 1) months following surgical resection |
|
Primary |
Longitudinal changes in symptom burden, function and general quality of life in patients with anorexia / cachexia) |
Functional Assessment of Anorexia / Cachexia Therapy ('FAACT') questionnaires will be used to assess symptom burden, quality of life and function |
Measured at baseline, following completion of any neo-adjuvant anti-cancer therapy, 6 (+/- 2) weeks, 6 (+/- 1) months and 12 (+/- 1) months following surgical resection |
|
Primary |
Longitudinal tissue-level changes in fat content |
Longitudinal changes in tissue level changes associated with cachexia, such as fat content of skeletal muscle |
Muscle biopsies will be taken at the time of surgical resection. Where participants are amenable, additional repeat needle biopsies of the quadriceps muscle will be performed at follow-up appointments 6 (+/- 1) months and 12 (+/- 1) months post surgery |
|
Primary |
Longitudinal tissue-level changes in collagen content |
Longitudinal changes in tissue level changes associated with cachexia, such as collagen content of skeletal muscle |
Muscle biopsies will be taken at the time of surgical resection. Where participants are amenable, additional repeat needle biopsies of the quadriceps muscle will be performed at follow-up appointments 6 (+/- 1) months and 12 (+/- 1) months post surgery |
|
Primary |
Longitudinal tissue-level changes in protein content |
Longitudinal changes in tissue level changes associated with cachexia, such as protein content of skeletal muscle |
Muscle biopsies will be taken at the time of surgical resection. Where participants are amenable, additional repeat needle biopsies of the quadriceps muscle will be performed at follow-up appointments 6 (+/- 1) months and 12 (+/- 1) months post surgery |
|
Primary |
Evaluation of multiparametric magnetic resonance imaging (MRI) in cachexia |
Evaluation of multiparametric MRI as a novel method for estimation of skeletal muscle mass and fat-infiltration across cachectic and weight-stable patients with cancer |
MRI scan performed pre-operatively |
|
Secondary |
Correlation of multiparametric magnetic resonance imaging (MRI) and tissue-level changes |
Correlation of multiparametric MRI estimates of skeletal muscle mass and fat infiltration with CT image derived analyses and tissue level changes in fat, collagen and protein content of skeletal muscle. |
MRI scan performed pre-operatively, tissue samples collected at the point of surgical resection. |
|
Secondary |
Correlation of multiparametric magnetic resonance imaging (MRI) and changes in physical function |
Evaluation of the relationship between physical function & muscle strength (as assessed by personal activity monitor (FitBit), 'timed up and go' test and isometric knee extension using a hand-held dynamometer) and multiparametric MRI assessment of thigh muscle quantity. |
MRI scan and assessments of physical function & muscle strength performed pre-operatively. |
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