The use of novel protein biomarkers in predicting clinical outcomes in patients with localised and metastatic colorectal cancer

Interventions: Predictive biomarker (plasma proteomics) study.
This is a prognostic/ predictive factor study investigating the utility of plasma proteomics in predicting toxicity and patient outcomes for patients with metastatic colorectal cancer. Plasma (2 10ml Tubes) is collected at 4 time points- (1) day 7-10 prior to chemotherapy, (2) prior to starting chemotherapy at day 1, (3) Day 3 of chemotherapy and (4) Day 15 of chemotherapy.
The decision to take either at Day 7 or 10 prior to chemotherapy is dependent on the day patients are reviewed in clinic and/ or convenience. This timepoint is to make sure there is no variation at this time period and the day of starting chemotherapy.
The types of chemotherapy are 5-fluorouracil based infusional chemotherapy which are undertaken on a 14 day cycle. In general, patients receiving adjuvant chemotherapy have 12 cycles (6 months of chemotherapy). There is no set number of cycles of chemotherapy for patients with metastatic disease and is physician discreation and ondividual patient response. In general, patients receive at least 4 cycles of chemotherapy prior to evaluation of response. This study is also recruiting patients not having chemotherapy and investigating the role of protoemics in predicting the development of cancer cachexia.
Primary outcome(s): Haematological and non-haematological toxicity after first 2 cycles of chemotherapy.
Haemotological assessment will be performed through collection of full blood count and assessed using the National Cancer Institute (NCI) Toxicity Criteria. Similarly, non-haematological tooxicity will be assessed using NCI criteria thorugh patients diaries and interview with clinical trials staff.[At the end of cycle 1 (at Day 15) and end of cycle 2 (day 29) of chemotherapy]
Study Design: Purpose: Diagnosis; Allocation: Non-randomised trial