Seeking adults diagnosed with bowel cancer who will be having surgery, chemotherapy or radiation therapy in the next 30 days for a study to assess the effectiveness of a new blood test to detect bowel cancer.
About this study
The ColoSTAT® test is being developed to provide an alternative option for people to undergo a colorectal cancer (CRC) screening test but for clinical, personal or cultural reasons, are unwilling or unable to use a stool test or are reluctant to undergo more invasive and costly procedures such as colonoscopy and sigmoidoscopy.
ColoSTAT® involves the collection of a blood sample, rather than stool, to assess the presence of components in the blood which, when assessed using a specifically designed algorithm, provide a CRC risk score. The algorithm uses the results from the blood test and incorporates other CRC risk factors, such as family history and lifestyle factors to determine this risk rating.
Anticipated enrolment close date: December 2022
Who can take part
- Diagnosed (via colonoscopy) with colorectal cancer and is progressing to colorectal surgery or neoadjuvant chemo or radiation therapy before surgery within 30 days of enrolment
- 40 to 85 years of age inclusive at the time of surgery
- Able and willing to provide a blood sample before surgery
- Able and willing to provide stool samples according to written instructions before surgery
- Medical history
- Weight, height, blood pressure, pulse, heart rate
- Health questionnaires
- Blood samples
- Stool sample
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.
The Clinical Trials Centre (CTC) is a dedicated, purpose-built space where we conduct clinical trials.
The CTC is located on Level 2 South. When you arrive, if you are unsure where to go, talk to one of our friendly volunteers or the information desk staff.