None listed
Conditions
Brief summary
This study is investigating the utility of a novel technique called 'proteomics' using serial blood samples to see if there are differences in plasma proteins whicn are able to predict toxicity and patient response to chemotherapy for patients with colorectal cancer. The hypothesis is that proteomic techniques are able to (1) identify patients more likely to respond to chemotherapy and predict overall outcome (2) identify patients more likely to expereince side effects and (3) predict the development of cancer cachexia in patients with metastatic colorectal cancer The intervention is the collection of blood samples at 4 time points during chemotherapy or observation. In addition there will be standard care (radiological and nutritional assessment) plus follow up as set out by the trial protocol.
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 depen
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.
Sponsors
Cancer Institute NSW
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with biopsy proven metastatic or locally advanced colorectal cancer starting chemotherapy involving infusional 5-fluoroouracil or Patients with biopsy proven metastatic colorectal cancer for symotomatic management only AND Eastern Cooperative Oncology Group (ECOG) performance status 0-2 AND age over 18 years AND ability to comply and provide informed written consent
Exclusion criteria
Pior chemotherapy for metastatic colorectal cancer or adjuvant chemotherapy in the last 6 months Other active malignancy Active autoimmune, inflammatory disease or infection Symptoms and signs of cancer cachexia
Outcome results
None listed