Scope Pilot Research Study

In the Capital Health Region, 18.6% of colorectal cancers are detected at stage 1, while 22.4% are already at stage IV. The Capital Health Region has 340,000 individuals aged 50-74, yet only 14.3% receive any colorectal cancer screening. These low screening rates may be attributed to lack of awareness, the limitations of the fecal occult blood testing (FOBT) and the unpleasant associations with both the FOBT and the colonoscopy. The limitations of the FOBT include low sensitivity for detection of adenomas and small cancers, the cumbersome method of stool collection on multiple days and the dietary restrictions, which make patient compliance low and introduce high probability of false positive tests and unnecessary colonoscopies.

Currently, there are two screening modalities available. The fecal occult blood testing (FOBT: Hemoccult II) detects blood in the stool that may be due to colonic adenomas or cancer. The second is colonoscopy, which is the gold standard in detecting colorectal lesions; however it carries the risks of bleeding and bowel perforation. FOBT is the recommended primary screening tool for patients at average risk for developing colorectal cancer. Large population-based randomized controlled trials have consistently demonstrated a significant survival benefit in patients who undergo annual or biannual screening with FOBT.

Recently, newer generation FOBT techniques, the FOBT immunochemical (FIT) has become available. These tests are more sensitive in detecting specifically human blood in the stool and do not require dietary restrictions. Recent studies have suggested the diagnostic performance of the FIT may be superior to standard Hemoccult II rates because of simplified sampling. As well, economic analysis have suggest that the use of FIT is superior to FOBT in diagnostic performance at a reasonable cost to a European population.

A urine specimen will also be obtained and analyzed for metabolomics for each subject. Metabolomics is the study of the global chemical composition of an organism. It utilizes technologies such as a nuclear magnetic resonance spectroscopy to study the metabolite / chemical composition, interactions, and changes in these levels in response to disease or environmental factors. By analyzing urine samples, it has been possible to identify the metabolite patterns characteristic of various diseases. In addition, the metabolite patterns of liver disease caused by cirrhosis and hepatitis, inflammatory bowel disease and cancer have been identified. Urine metabolomics analysis may offer a new sensitive, yet inexpensive screening tool for colorectal cancer.

Inclusion criteria

• Patients on gastrointestinal wait-lists for screening colonoscopy
• patients that are 50 - 75 years of age at average risk for colorectal cancer OR patients that are 40 - 75 years of age and at high risk for colorectal cancer
• Patients that are healthy or have co-morbidities that are currently stable
• patients that are willing to complete 1 FOBT, 2 FITs, urine for metabolomics, attend an education session, colonoscopy and evaluate the SCOPE program and education resources.
• individuals will be eligible to participate in the pilot if their last colonoscopy was a minimum of five (5) years ago. Less than 5 years is acceptable if the procedure report on the last colonoscopy recommends repeat colonoscopy at an earlier interval.

Exclusion criteria

• under 40 years of age or over 75 years of age
• inability to understand / sign informed consent (applies to individuals that do not speak or read English)
• use of warfarin or any anticoagulant medications (includes low molecular weight heparin)
• rectal bleeding
• past history of failed or extremely difficult colonoscopy
• insulin dependent diabetes
• history of inflammatory bowel disease
• use of Bi-pap or home oxygen
• Asthma or COPD described as severe
• chronic disease that is suspected / under investigation but NYD
• chronic / acute disease process that is not stable or not in remission
• possible lynch syndrome
• renal disease requiring any type of dialysis
• BMI > 35