Scope Pilot Research Study
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      Colorectal cancer is a major public health concern in Alberta. Colorectal Cancer is the
      fourth most common diagnosed cancer and second overall in terms of cancer deaths in Canada.
      One in 14 males and 1 in 16 females aged 50-74 will be diagnosed with colorectal cancer and
      will have an overall 1 in 28 chance of dying from colorectal cancer. While colorectal cancer
      is surgically curable if diagnosed in the early stages, with five year survival rates of 90%
      versus 10% if detected at more advanced stages, less than 20 % of all individuals in this age
      bracket traditionally have undergone colorectal cancer screening. Colorectal cancer often
      presents with non-specific symptoms where non-cancerous polyps are commonly found. If these
      polyps are left in place, they may grow over time and progress from a non-cancerous mass to
      symptomatic cancerous tumors; therefore, early screening in those patients without symptoms
      may thereby prevent the progression from a non-cancerous to cancerous finding.

      The hypothesis, or theory being studied in the SCOPE Pilot research study, is that
      implementation of a colorectal screening program would decrease colorectal cancer prevalence,
      increase the long-term survival ratio for patients, and decrease burden on the health care
      system. Moreover, early detection and treatment of colorectal cancer has the potential to
      increase the lifespan of patients and decrease health care costs.

      The SCOPE Pilot Research study will recruit 1000 individuals between the ages of 50 - 74 of
      average to high risk for developing colorectal cancer as determined by their referring
      Gastroenterologists. Those patients who are ages 40-50 will also be eligible if they have a
      personal or family history of colorectal cancer. Patients referred to the SCOPE Pilot program
      will be further screened for eligibility, and if no exclusion criterion is present, will be
      invited to attend an education session and research program. The SCOPE Pilot research study
      will compare the current fecal occult blood testing (FOBT - Hemoccult II) with newly
      available FOBT blood testing along with colonoscopy therapy. It will also encompass
      educational information, risk stratification, screening for both average and high risk
      patients, and colonoscopy.
    

Detailed description: 
      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.
    

Intervention name(s): colonoscopy
Intervention type(s): Procedure
Intervention description(s): Patients will provide stool and urine samples and will be scheduled to undergo a colonoscopy. The colonoscopy will be done per standard of care - no study specific procedural requirements imposed.
Other intervention name(s): Endoscopy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Family practitoners will refer patients to Gastroenterologist physicians for consideration
        into the SCOPE Pilot Research program. They will be evaluated for suitability initially by
        gastroenterologists who will then refer them directly to the SCOPE Pilot research program
        to further assess suitability. Those patients who meet the inclusion criteria with no
        exclusion criteria present will be invited to an education session and invited to partake
        in the research program if willing.