Scope Pilot Research Study

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.

Conditions

• Colorectal Cancer

Interventions

PROCEDURE

colonoscopy

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.

Sponsors & Collaborators

• Royal Alexandra Hospital

  collaborator OTHER

• University of Alberta

  lead OTHER

Principal Investigators

• Daniel C Sadowski, MD · Royal Alexandra Hospital

• Richard N Fedorak, MD · University of Alberta

• Clarence K Wong, MD · Royal Alexandra Hospital

Eligibility

Min Age

40 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2008-04-30

Primary Completion

2009-10-31

Completion

2009-10-31

Countries

• Canada

Study Locations