None listed
Conditions
Brief summary
The purpose of the CATCHER-1 study is to assess the usefulness of a blood test called Colvera in patients with bowel cancer over time. Colvera may provide information about the progress of bowel cancer and help to determine if a cancer treatment is working. When bowel cancer has spread to other organs or parts of the body (for example, liver, lung and the lining of the abdomen), this is known as advanced or metastatic bowel caner. Patients with advanced bowel cancer are generally treated with different types of drug therapy (systemic therapy) with the aim to control the cancer, slow its growth and manage symptoms. To monitor if systemic therapies are effective or not, patients undergo regular CT scans and often a blood test called CEA. However, sometimes, it can time for changes to become noticeable on CT, such that the images may not reflect a patient’s true clinical state. CEA, used alone, can have variable results. Who is it for? You may be eligible for this study if you are an adult who is commencing a new cancer treatment. Study details Colvera is designed to identify small amounts of altered DNA which may leak from a tumor into the bloodstream, called circulating tumor DNA or ctDNA. Colvera detects the presence or absence of two genes in ctDNA, (BCAT1 and IKZF1), that are often associated with colorectal cancer growth. While Colvera detects changes found in most advanced bowel cancers , Colvera may not be detectable in all patients. In this study, patients who are starting a new drug treatment for advanced bowel cancer, will undergo additional blood sampling for Colvera and CEA in addition to planned treatment. Your doctor remains in control of your care and this study will not impact on the standard of care you receive. The study is designed to monitor your care to evaluate if the level of Colvera in the blood is an effective marker in advanced bowel cancer, including in comparison with standard measures (CT scan and CEA). It is hoped that this research will determine whether Colvera is an effective way of determining whether treatment is effective, and if it is, will provide a more accurate way of guiding treatment in those with colorectal cancer
Interventions
This is an observational trial of a potential biomarker, with no influence on the patients' treatment and is therefore non-interventional
1. Colvera and CEA will be taken at the following time points
a. Cohort A (first 5 patients): daily (Mon-Fri) for 1 week prior to starting systemic therapy, and daily (Mon-Fri) during cycle 1 week 1 of systemic therapy. Then every 2 weeks for 12 weeks and every 4 weeks thereafter. An interim analysis will be undertaken to evaluate preliminary results to dete
This is an observational trial of a potential biomarker, with no influence on the patients' treatment and is therefore non-interventional 1. Colvera and CEA will be taken at the following time points a. Cohort A (first 5 patients): daily (Mon-Fri) for 1 week prior to starting systemic therapy, and daily (Mon-Fri) during cycle 1 week 1 of systemic therapy. Then every 2 weeks for 12 weeks and every 4 weeks thereafter. An interim analysis will be undertaken to evaluate preliminary results to determine the frequency of testing in subsequent cohorts. b. Cohort B (next 20 patients): at baseline (prior to commencement of systemic therapy), then frequency of testing is to be determined, likely every 2 weeks for 12 weeks and every 4 weeks thereafter. c. Cohort C (next 25 patients): at baseline (prior to commencement of systemic therapy), then frequency as determined by the emerging data from the first 2 cohorts, likely every 4 to 6 weeks. Upon cessation of all anti-cancer therapy (i.e. patients receiving best supportive care only), Colvera and CEA blood testing will become voluntary only up until death for a maximum of 20 years.
Sponsors
Monash Health
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
18 years or over. Patient with metastatic adenocarcinoma of colon or rectum who are commencing a new line of systemic therapy. ECOG 0-2 and candidates for systemic therapy.
Exclusion criteria
Medical or psychiatric condition that would preclude compliance with the protocol.
Outcome results
None listed