Clinical trial · Observational
Scope Pilot Research Study
Stop Colorectal Cancer Through Prevention and Screening
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| colonoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- 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.
- timeFrame
- FOBT, FIT (Hemoccult ICT) and MagStream Hemsp will be obtained prior to colonoscopy.
Secondary outcomes (1)
- measure
- Estimate the probability of participants of the SCOPE pilot who have adenomas or colorectal cancer using urine metabolomics and correlate those with results from the FOBT / FIT's and screening colonoscopy.
- timeFrame
- Urine sample obtained prior to colonoscopy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available