Scope Pilot Research Study

NCT00893503 | Completed

• 2 other identifiers: AHS-160408-SPPro00002130
• Study Type: observational
• Target: 1,248
• Locations: 1 country
• Sites: 2

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 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

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

• 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.

  Urine sample obtained prior to colonoscopy

Interventions

colonoscopy PROCEDURE

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.

Also known as: Endoscopy

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• Royal Alexandra Hospital: collaborator

Study Sites (2)

Royal Alexandra Hospital

Edmonton, Alberta, T5H 3V9, Canada

Location

Walter C. MacKenzie Centre, University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Colonoscopy; Endoscopy

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Daniel C Sadowski, MD

  Royal Alexandra Hospital

  PRINCIPAL INVESTIGATOR

• Richard N Fedorak, MD

  University of Alberta

  STUDY DIRECTOR

• Clarence K Wong, MD

  Royal Alexandra Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 5, 2009
• First Posted: May 6, 2009
• Study Start: April 1, 2008
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: March 8, 2011

Record last verified: 2011-03

Locations

CA (2)