None listed
Conditions
Brief summary
Purpose of study. To determine if a simple blood sample can be used to accurately test for colorectal cancer Who is it for? You may be eligible for this study if you are an adult over 40 years of age who has either been very recently diagnosed with colorectal cancer and is progressing to surgery or is scheduled to undergo a colonoscopy in the next 90 days. Study details: All participants in this study will be required to attend a short visit with researchers in order to provide a sample of blood and answer a few questions. Participants will also be asked to provide a faecal sample and give access to their colonoscopy reports. Researchers will then contact participants by phone within a month of the visit for a short check-up. It is hoped that this research will help determine if a simple blood test is effective in detecting colorectal cancer.
Interventions
This prospective, cross-sectional, multi-centre, blinded clinical trial evaluates the performance of the ColoSTAT as an in vitro diagnostic test (IVD) for the early detection of colorectal cancer. Participants will be recruited from two cohorts: Chort 1, patients recently diagnosed via colonoscopy with colorectal cancer who are progressing to colorectal surgery or neoadjuvant treatment as part of their normal standard of care; Cohort 2, patients with no prior history of colorectal cancer who hav
This prospective, cross-sectional, multi-centre, blinded clinical trial evaluates the performance of the ColoSTAT as an in vitro diagnostic test (IVD) for the early detection of colorectal cancer. Participants will be recruited from two cohorts: Chort 1, patients recently diagnosed via colonoscopy with colorectal cancer who are progressing to colorectal surgery or neoadjuvant treatment as part of their normal standard of care; Cohort 2, patients with no prior history of colorectal cancer who have been referred for colonoscopy by their consulting physician. Participants will be asked to donate around 18 mL of blood for use in the ColoSTAT test. Further, if they do not have a valid result from a faecal immunochemical test (FIT) completed within the preceding 6 months, participants will be asked to complete a FIT sample collection using a commercial FIT home collection kit (provided) and return the samples to the study site for shipment to a central laboratory for testing . Physically, participation in the trial will involve collection of the blood sample for the ColoSTAT test, completion of a home FIT sample collection if needed and return of the completed kit to the the study site. Additionally, information that will be collected at that first visit will comprise: Details of smoking status and age (known risk factors for colorectal cancer), any personal and/or family medical history of colorectal cancer, results from a FIT performed within the previous 6 months and a listing of any concomitant medications. Vital signs, including height, weight, waist circumference, body mass index, blood pressure and heart rate will also be collected and reported. This first Visit is expected to take around 1-2 hour to complete. Sometime during the period Day 10 through 28 from Visit 1, participants will receive a phone call from the study site to collect information on any adverse event that may have occurred following blood or FIT sample collection. This follow up, phone interview "Visit 2" is expected to take around 30 minutes. End of study is the date the participant will undergo either surgery/neoadjuvant treatment (Cohort 1) or colonoscopy (Cohort 2) as per standard of care.
Sponsors
Vision Tech Bio Pty Ltd
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
40 Years to 84 Years
Healthy volunteers
No
Inclusion criteria
For Cohort 1: • Participant is diagnosed colonoscopically with colorectal cancer and is progressing to colorectal surgery or neoadjuvant chemo- or radiation therapy within 30 days of enrolment. • Participant is able to comprehend, sign, and date the written informed consent document to participate in the study. • Participant is able and willing to be accessible for blood draw prior to surgery. • Participant is able and willing to provide stool samples according to written instructions provided to them. For Cohort 2: • Participant is scheduled to undergo a colonoscopy within 90 days of enrolment. • Participant is able to comprehend, sign, and date the written informed consent document to participate in the study. • Participant is able and willing to be accessible for blood draw prior to start of bowel preparation for colonoscopy. • Participant is able and willing to provide stool samples according to written instructions provided to them.
Exclusion criteria
For Cohort 1: • Participant has any condition which, in the opinion of the investigator should preclude participation in the study. • Participation in any "interventional" clinical study within the previous 30 days in which an experimental treatment is administered or might be administered through a randomized assignment of the Participant to one or more study groups. For Cohort 2: • Participant has any condition which, in the opinion of the investigator should preclude participation in the study. • Participant has a history of aerodigestive tract cancer. • Participant has had a prior colorectal resection for any reason other than sigmoid diverticular disease. • Participant has had overt rectal bleeding, e.g., hematochezia or melena, within the previous 30 days. (Blood on toilet paper, after wiping, does not constitute rectal bleeding). • Participation in any "interventional" clinical study within the previous 30 days in which an experimental treatment is administered or might be administered through a randomized assignment of the Participant to one or more study groups.
Outcome results
None listed