Colorectal CancerNCT00865527
Pilot Study of Colon Cancer Screening Tests
A study testing Fecal occult blood test, Virtual colonoscopy and Optical colonoscopy in people with Colorectal Cancer and Colon Cancer, run by Hamilton Health Sciences Corporation at 1 site in Canada.
Trial summary
Colon cancer is the second leading cause of cancer death in North America. These deaths are preventable with proper screening. Fecal occult blood testing, virtual colonoscopy, and standard (optical) colonoscopy are all options for colon cancer screening, but it is not known which is the best at preventing death from… Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer, Colon Cancer, Adenomatous Polyps
- What is being tested?
- Fecal occult blood test, Virtual colonoscopy and Optical colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2010to Sep 2011
- Phase
- Interventional
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All individuals age 50 to 70 years
Who cannot join
- Unable to give informed consent
- History of colorectal cancer
- History of adenomatous polyp
- History of inflammatory bowel disease
- Prior participation in FOBT screening
- Prior refusal to participate in FOBT screening
Show all 10Show fewer
- Flexible sigmoidoscopy within the previous 3 years
- Virtual colonoscopy within the previous 3 years
- Optical colonoscopy within the previous 3 years
- Severe of terminal illness that would preclude benefit from colon cancer screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Comparison of Virtual Colonoscopy, Optical Colonoscopy, and Fecal Occult Blood Testing for Colorectal Cancer Screening: a Pilot Study
Colon cancer is the second leading cause of cancer death in North America. These deaths are preventable with proper screening. Fecal occult blood testing, virtual colonoscopy, and standard (optical) colonoscopy are all options for colon cancer screening, but it is not known which is the best at preventing death from colon cancer. A large study comparing these three tests is desperately needed. In this pilot study, the investigators want to find out what percentage of patients will show up for their screening test once enrolled. This will provide crucial information for the successful execution of the larger study.
- Conditions
- Colorectal Cancer, Colon Cancer, Adenomatous Polyps
- Being tested
- Fecal occult blood test, Virtual colonoscopy, Optical colonoscopy
- Keywords
- Colorectal cancer, Colon cancer, Adenomatous polyps, Screening, Fecal occult blood test, Computed tomographic colonography, Colonoscopy
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Adenomatous Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal occult blood testOther
Also called FOBT
FOBT
Virtual colonoscopyProcedure or surgery
Also called CT colonography, computed tomographic colonography
computed tomographic colonography
Optical colonoscopyProcedure or surgery
Also called Colonoscopy
optical (conventional / endoscopic) colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| Fecal Occult Blood Test | Active comparator | fecal occult blood test Receives: Other: Fecal occult blood test |
| Virtual Colonoscopy | Active comparator | virtual colonoscopy Receives: Procedure: Virtual colonoscopy |
| Optical Colonoscopy | Active comparator | optical (conventional / endoscopic) colonoscopy Receives: Procedure: Optical colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of enrolled patients who attend for their assigned screening test
Measured: Immediate
Secondary outcomes (5)
Proportion of non-responders to mailed invitations, who respond to telephone or mail reminders.
Measured: Immediate
Proportion of patients requiring polypectomy after virtual colonoscopy who receive same or next day optical colonoscopy for polypectomy
Measured: 6 months
Proportion of subjects who cross over to another arm of the study
Measured: 6 months
Proportion of patients found to have an advanced adenoma
Measured: 6 months
Proportion of patients found to have invasive colorectal carcinoma
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2009 (estimated)
- Study startMar 2010
- Primary completionMar 2011
- Study completionSep 2011
Why it stopped: Lack of ongoing funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hamilton Health Sciences Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- McMaster University
- Responsible party
- Principal investigator, John You, McMaster University
- Investigators
- John J You, MD MSc FRCPC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00865527
- Sponsor's protocol ID
- CTC1.0
- Status last verified
- Mar 2016
- First submitted
- 18 Mar 2009
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
You JJ, Liu Y, Kirby J, Vora P, Moayyedi P. Virtual colonoscopy, optical colonoscopy, or fecal occult blood testing for colorectal cancer screening: results of a pilot randomized controlled trial. Trials. 2015 Jul 9;16:296. doi: 10.1186/s13063-015-0826-7.
PubMed 26156248Wong AD, Kirby J, Guyatt GH, Moayyedi P, Vora P, You JJ. Randomized controlled trial comparing telephone and mail follow-up for recruitment of participants into a clinical trial of colorectal cancer screening. Trials. 2013 Feb 11;14:40. doi: 10.1186/1745-6215-14-40.
PubMed 23399518
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Comparison of Virtual Colonoscopy, Optical Colonoscopy, and Fecal Occult Blood Testing for Colorectal Cancer Screening: a Pilot Study
- ClinicalTrials.gov ID
- NCT00865527
- Acronym / sponsor ID
- CTC1.0
- Conditions
- Colorectal Cancer, Colon Cancer, Adenomatous Polyps
- Keywords
- Colorectal cancer, Colon cancer, Adenomatous polyps, Screening, Fecal occult blood test, Computed tomographic colonography, Colonoscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of ongoing funding
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Hamilton Health Sciences CorporationUniversity, hospital or other
- Collaborators
- McMaster University
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 19 Mar 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.
Colon cancer is the second leading cause of cancer death in North America. These deaths are preventable with proper screening. Fecal occult blood testing, virtual colonoscopy, and standard (optical) colonoscopy are all options for colon cancer screening, but it is not known which is the best at preventing death from colon cancer. A large study comparing these three tests is desperately needed. In this pilot study, the investigators want to find out what percentage of patients will show up for their screening test once enrolled. This will provide crucial information for the successful execution of the larger study.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fecal Occult Blood Test | Active comparator | Other: Fecal occult blood testfecal occult blood test |
| Virtual Colonoscopy | Active comparator | Procedure: Virtual colonoscopyvirtual colonoscopy |
| Optical Colonoscopy | Active comparator | Procedure: Optical colonoscopyoptical (conventional / endoscopic) colonoscopy |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All individuals age 50 to 70 years
Key exclusion criteria (10 listed)
- Unable to give informed consent
- History of colorectal cancer
- History of adenomatous polyp
- History of inflammatory bowel disease
- Prior participation in FOBT screening
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 |
|---|---|---|
| Fecal occult blood testAlso: FOBTFOBT | Other | Fecal Occult Blood Test |
| Virtual colonoscopyAlso: CT colonography, computed tomographic colonographycomputed tomographic colonography | Procedure or surgery | Virtual Colonoscopy |
| Optical colonoscopyAlso: Colonoscopyoptical (conventional / endoscopic) colonoscopy | Procedure or surgery | Optical Colonoscopy |
Primary outcome
Proportion of enrolled patients who attend for their assigned screening test
Time frame: Immediate
5 secondary outcomes
Proportion of non-responders to mailed invitations, who respond to telephone or mail reminders.
Time frame: Immediate
Proportion of patients requiring polypectomy after virtual colonoscopy who receive same or next day optical colonoscopy for polypectomy
Time frame: 6 months
Proportion of subjects who cross over to another arm of the study
Time frame: 6 months
Proportion of patients found to have an advanced adenoma
Time frame: 6 months
Proportion of patients found to have invasive colorectal carcinoma
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Lack of ongoing funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2016.
- Derived from this study: PubMed 26156248You JJ, Liu Y, Kirby J, Vora P, Moayyedi P. Virtual colonoscopy, optical colonoscopy, or fecal occult blood testing for colorectal cancer screening: results of a pilot randomized controlled trial. Trials. 2015 Jul 9;16:296. doi: 10.1186/s13063-015-0826-7.
- Derived from this study: PubMed 23399518Wong AD, Kirby J, Guyatt GH, Moayyedi P, Vora P, You JJ. Randomized controlled trial comparing telephone and mail follow-up for recruitment of participants into a clinical trial of colorectal cancer screening. Trials. 2013 Feb 11;14:40. doi: 10.1186/1745-6215-14-40.
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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.
John J You, MD MSc FRCPC principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal occult blood test, Virtual colonoscopy and Optical colonoscopy in people with Colorectal Cancer and Colon Cancer, run by Hamilton Health Sciences Corporation at 1 site 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 1 inclusion and 10 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: stopped early, as of the sponsor's last update on 31 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: Lack of ongoing funding). Results are not available in the source record.
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?
Proportion of enrolled patients who attend for their assigned screening test (time frame: Immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00865527, which also lists 2 linked publications.
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 31 Mar 2016.