Status:
COMPLETED
Scope Pilot Research Study
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Royal Alexandra Hospital
Conditions:
Colorectal Cancer
Eligibility:
All Genders
40-75 years
Brief 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 ...
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% rec...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
1248 Patients enrolled
Trial Details
Trial ID
NCT00893503
Start Date
April 1 2008
End Date
October 1 2009
Last Update
March 8 2011
Active Locations (2)
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1
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
2
Walter C. MacKenzie Centre, University of Alberta
Edmonton, Alberta, Canada, T6G 2B7