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Stop Colorectal Cancer Through Prevention and Screening

40 Years
75 Years
Not Enrolling
Colorectal Cancer

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Trial Information

Stop Colorectal Cancer Through Prevention and Screening

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

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

- 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

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

- 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

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Compare the diagnostic performance characteristics of the guaiac based Hemoccult II FOBT and two FIT's, the Hemoccult ICT and MagStream HemSp, using colonoscopy as the gold standard.

Outcome Time Frame:

FOBT, FIT (Hemoccult ICT) and MagStream Hemsp will be obtained prior to colonoscopy.

Safety Issue:


Principal Investigator

Daniel C Sadowski, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Royal Alexandra Hospital


Canada: Ethics Review Committee

Study ID:




Start Date:

April 2008

Completion Date:

October 2009

Related Keywords:

  • Colorectal Cancer
  • Colorectal Neoplasms