Colorectal CancerSCOPENCT00893503
Scope Pilot Research Study
An observational study of Colorectal Cancer, run by University of Alberta at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- colonoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 1,248 participants
- Where
- 2 sitesCanada
- Study dates
- Apr 2008to Oct 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9
Walter C. MacKenzie Centre, University of Alberta
Edmonton, Alberta, T6G 2B7
About this study
Official title: Stop Colorectal Cancer Through Prevention and Screening
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.
Read the 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% 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 FOBT.
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.
- Conditions
- Colorectal Cancer
- Being tested
- colonoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colonoscopyProcedure or surgery
Also called Endoscopy
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Urine sample obtained prior to colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2009 (estimated)
- Study startApr 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,248 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Alexandra Hospital
- Investigators
- Daniel C Sadowski, MD, Principal investigator, Royal Alexandra HospitalRichard N Fedorak, MD, Study director, University of AlbertaClarence K Wong, MD, Study director, Royal Alexandra Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00893503
- Sponsor's protocol ID
- AHS-160408-SP
- Other IDs
- Pro00002130
- Acronym
- SCOPE
- Status last verified
- Mar 2011
- First submitted
- 5 May 2009
- Last updated
- 8 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stop Colorectal Cancer Through Prevention and Screening
- ClinicalTrials.gov ID
- NCT00893503
- Acronym / sponsor ID
- SCOPE / AHS-160408-SP
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,248 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Royal Alexandra Hospital
- Study start
- Apr 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 6 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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% 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 FOBT.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colonoscopyAlso: EndoscopyPatients 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. | Procedure or surgery | – |
Primary outcome
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.
Time frame: FOBT, FIT (Hemoccult ICT) and MagStream Hemsp will be obtained prior to colonoscopy.
1 secondary outcome
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.
Time frame: Urine sample obtained prior to colonoscopy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel C Sadowski, MD principal investigator
Royal Alexandra Hospital
Richard N Fedorak, MD study director
University of Alberta
Clarence K Wong, MD study director
Royal Alexandra Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by University of Alberta at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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. (time frame: FOBT, FIT (Hemoccult ICT) and MagStream Hemsp will be obtained prior to colonoscopy.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2011.