None listed
Conditions
Brief summary
This study is recruiting participants with advanced or metastatic colorectal cancer, who are going to start on a new course of chemotherapy. It will investigate a new blood test, called Midkine, and determine if it is better than the standard tests (CEA and CT scans), at identifying whether or not the chemotherapy is effective. Who is it for? You may be eligible to join this study if you are 18 years or over, have been diagnosed with metastatic or locally advanced colorectal cancer and due to starting on a new course of chemotherapy. Full inclusion criteria for this study can be found in the appropriate section of this form. Trial details In this study, you will be observed for a total period of 6 months, or until your cancer progresses. You will have standard and midkine blood tests before starting chemotherapy, a midkine sample taken at 2 weeks and then standard and midkine blood tests every 3-4 weeks, whilst receiving chemotherapy for your colorectal cancer. The interval between blood tests depends on when blood tests are required for the chemotherapy regimen that is being used. The only extra blood test you will require is for midkine at 2 weeks after starting on the study.
Interventions
Participants will be allowed to receive whichever chemotherapy regimen thier oncologist recommends. They will be studied for 6 months, or until their cancer progresses, and will have blood tests at 2 weeks and then every 3-4 weeks, whilst receiving chemotherapy for their colorectal cancer. The blood test for midkine involves an extra 12mL (2-3 teaspoons) of blood to be taken, which can be done at the same time as the usual blood tests for monitoring the effects of the chemotherapy. The blood tests can be taken at any Hunter Area Pathology Service (HAPS) collection centre, and will be taken using the same procedure as normal blood tests. There is no need to fast prior to collection. The only extra blood test for midkine is 2 weeks after the first dose of chemotherapy. The interval between blood tests depends on when blood tests are required for the chemotherapy regimen that is being used. Participants will also receive standard monitoring tests: carcino-embryonic antigen (CEA) every 3-4 weeks and computed tomography (CT) scans every 8 weeks.
Sponsors
Eligibility
Inclusion criteria
Ability to give informed consent Metastatic or locally advanced colorectal cancer Starting on a new course of chemotherapy for colorectal cancer Adequate organ function to permit chemotherapy to be given Life expectancy of more than 3 months Measurable or non-measurable lesions Ability to comply with study procedures
Exclusion criteria
Past history of malignancy, other than non-melanoma skin cancers Current active inflammatory, autoimmune or infective process