None listed
Conditions
Brief summary
The purpose of this study is to measure cancer specific gene changes in the blood as a biomarker in monitoring disease status in colorectal cancer. Biomarkers are substances that can be found in blood and/or tumour tissue and may be used to measure the effects or progress of a disease or condition. Genes are substances in the body which contain information about characteristics us as individuals. Previous studies have found that the majority of colorectal cancers contain mutations in several genes (the gene is changed or different from the common form) and that these cancerrelated mutations can be detected in the blood. Identifying biomarkers are important because they may be linked with disease progression, they may help to identify people who are most likely to benefit from a certain treatment such as chemotherapy, or they may be used to track the status of cancer without the need for invasive procedures, such as biopsies.
Interventions
This is a prospective study involving the collection of blood samples for the purposes of measuring circulating DNA from patients with resectable colorectal cancer liver metastases. Two distinct cohorts of patients, those undergoing initial liver resection followed by 12 cycles of FOLFOX and those given pre and postoperative chemotherapy will be treated and followed according to standard protocols.
60 mls of blood will be collected at specified timpoints. - 60 mls will be collected at each timep
This is a prospective study involving the collection of blood samples for the purposes of measuring circulating DNA from patients with resectable colorectal cancer liver metastases. Two distinct cohorts of patients, those undergoing initial liver resection followed by 12 cycles of FOLFOX and those given pre and postoperative chemotherapy will be treated and followed according to standard protocols. 60 mls of blood will be collected at specified timpoints. - 60 mls will be collected at each timepoint. COHORT 1 - Initial Surgery the timepoints are: Timepoint 1 - Screening Timepoint 2 - 4 weeks post surgery Timepoint 3 Post cycle 6 adjuvant chemotherapy (Day 1 Cycle 7) Timepoint 4 - Post cycle 12 (Days 3 at CADD disconnect) Timepoint 5 - 10 every 3 months (3 mth follow up; 6mth follow up; 12 mth follow up; 18 mth follow up and 24 mth follow up) COHORT 2 - Pre-op Chemo timpoints are: Timepoint 1 - Screening Timepoint 2 - Post cycle 1 (day 1 cycle 2) Timepoint 3 - Post cycle 2 (day 1 cycle 3) Timepoint 4 - post cycle 4 (day 1 cycle 5) Timepoint 5 - 4 weeks post surgery Timepoint 6 - Post cycle 12 (day 3 at CADD disconnect) Timepoint 7 -10 - 3 monthly follow - ups ( 3 mths; 6 mths; 9 mths; 12 mnths) Timepoint 11 & 12 - 6 monthly follow - ups (18 mths and 24 mths)
Sponsors
Ludwig Institute for Cancer Research
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients with histologically confirmed primary colorectal cancer 2. Patients with resected primary tumours or planned for curative primary tumour resection. 3. Patients with resectable liver metastases following workup including CT scans of chest, abdomen and pelvis (or MRI if unable to undertake CT scan) and whole body PET scan. 4. Patients fit for surgery 5. Patients fit for combination chemotherapy (5-FU and oxaliplatin) 6. Patients willing to provide written informed consent
Exclusion criteria
1. History of another primary cancer within the last 5 years, with the exception of non-melanomatous skin cancer and carcinoma in situ of the cervix. 2. Medical or psychiatric condition or occupational responsibilities that may preclude compliance with the protocol 3. Patients that are not accessible for follow-up
Outcome results
None listed