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 stage II and IV 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 tumour DNA from two distinct cohorts of patients:
COHORT A: Patients with curatively resected stage II colon cancer- subgroups will be enrolled according to whether adjuvant chemotherapy is recommended by patient’s treating oncologist. Group A - Chemotherpay; Group B - No Chemo (serial blood collection) and Group C - No chemotherapy (baseline sample). Timepoints for each group in COHOR
This is a prospective study involving the collection of blood samples for the purposes of measuring circulating tumour DNA from two distinct cohorts of patients: COHORT A: Patients with curatively resected stage II colon cancer- subgroups will be enrolled according to whether adjuvant chemotherapy is recommended by patient’s treating oncologist. Group A - Chemotherpay; Group B - No Chemo (serial blood collection) and Group C - No chemotherapy (baseline sample). Timepoints for each group in COHORT A are as follows: Group A - 60mls of blood will be collected at 11 timepoints- Timepoint 1 - Baseline (4-8 weeks post operation) Timepoint 2 - Post 3 month of chemotherapy Timepoint 3 - Completion of chemotherapy Timepoint (4 - 11) -3 monthly follow ups post completion of treatment (3mths; 6mths; 9mths; 12mths; 15mths; 18 mths; 21 mnths and 24mths) Group B - 60mls of blood will be collected at 9 timepoints - Timepoint 1 - Baseline (4-8 weeks post operation) Timepoint (2 - 9) -3 monthly follow ups post completion of treatment (3mths; 6mths; 9mths; 12mths; 15mths; 18 mths; 21 mnths and 24mths) Group C - 60mls of blood will be collected at 1 timepoint - Timepoint 1 Baseline (4-8 weeks post operation) COHORT B - Patients with metastatic (stage IV) colorectal cancer undergoing first line chemotherapy. 60 mls of blood will be collected at 3 timepoints - Timepoint 1 - Priot to Cycle 1 Day 1 chemotherapy Timepoint 2 - Cycle 1 Day 3 chemotherapy Timepoint 3 - Cycle 2 Day 1 cemotherapy
Sponsors
Ludwig Institute for Cancer Research
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with histologically confirmed primary colorectal cancer For the stage II colon cancer (cohort A) -Patients with curatively resected stage II primary colon cancer -Patients must be registered for study within 10 weeks of surgery For the metastastic (stage IV) colorectal cancer (cohort B) -Patients with measurable disease by RECIST criteria version 1.1 -Patients fit to receive standard first line combination chemotherapy, with cytotoxic agents and any biological therapy given at standard doses. ECOG performance status 0 - 2 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 with major organ impairment. 4. Patients that are not accessible for follow-up.
Outcome results
None listed