Colon CancerNCT00245492
Chromocolonoscopy for the Detection of Flat Adenomas in Routine Colorectal Cancer Screening.
A study testing Chromocolonoscopy in people with Colon Cancer and Polyp, run by Indiana University at 3 sites in United States.
Trial summary
The proposed research aims to determine the prevalence, size, shape and histology of flat colorectal neoplasms in a cohort of asymptomatic, average-risk individuals presenting for screening colonoscopy. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer, Polyp, Adenoma
- What is being tested?
- Chromocolonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 792 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2006to Dec 2008
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing screening colonoscopy
Who cannot join
- Age < 50
- Prior colon resection
- Inflammatory bowel disease
- Prior colonoscopy or sigmoidoscopy
- More than one first-degree relative with colon cancer
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Indiana University
Indianapolis, Indiana, 46202
Roudebush VA Medical Center
Indianapolis, Indiana
SUNY Stony Brook
Stony Brook, New York
About this study
The proposed research aims to determine the prevalence, size, shape and histology of flat colorectal neoplasms in a cohort of asymptomatic, average-risk individuals presenting for screening colonoscopy. Patients will be randomized to either conventional colonoscopy or chromocolonoscopy, where the entire colon will be sprayed with indigocarmine dye and examined in the usual manner. The primary outcome will be the total number of adenomas detected, with special attention to the subgroup of flat and depressed lesions. To promote the generalizability of the results, neoplasms will be described according to standard Western and Japanese classification schemes.
- Conditions
- Colon Cancer, Polyp, Adenoma
- Being tested
- Chromocolonoscopy
- Keywords
- Colonoscopy, Chromoscopy, Prevention
- Medical subject headings
- Colonic Neoplasms, Polyps, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChromocolonoscopyProcedure or surgery
Indigocarmine dye applied to entire colon to highlight mucosal detail and enhance detection of flat lesions.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Chromocolonoscopy Receives: Procedure: Chromocolonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of adenomas detected by chromocolonoscopy versus standard colonoscopy.
Measured: Cross-sectional prevalence of adenomas between the 2 study groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2005 (estimated)
- Study startMay 2006
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 792 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Gastroenterology, Stony Brook University, University of Chicago
- Investigators
- Charles J Kahi, MD, Principal investigator, Indiana University School of Medicine, Roudebush VA Medical Center, Indianapolis, Indiana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245492
- Sponsor's protocol ID
- 0508-64
- Other IDs
- 2005ACG-100CRC
- Status last verified
- Jan 2009
- First submitted
- 26 Oct 2005
- Last updated
- 28 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chromocolonoscopy for the Detection of Flat Adenomas in Routine Colorectal Cancer Screening.
- ClinicalTrials.gov ID
- NCT00245492
- Acronym / sponsor ID
- 0508-64
- Conditions
- Colon Cancer, Polyp, Adenoma
- Keywords
- Colonoscopy, Chromoscopy, Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 792 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- American College of Gastroenterology, Stony Brook University, University of Chicago
- Study start
- May 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 28 Oct 2005 (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.
The proposed research aims to determine the prevalence, size, shape and histology of flat colorectal neoplasms in a cohort of asymptomatic, average-risk individuals presenting for screening colonoscopy. Patients will be randomized to either conventional colonoscopy or chromocolonoscopy, where the entire colon will be sprayed with indigocarmine dye and examined in the usual manner. The primary outcome will be the total number of adenomas detected, with special attention to the subgroup of flat and depressed lesions. To promote the generalizability of the results, neoplasms will be described according to standard Western and Japanese classification schemes.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: ChromocolonoscopyChromocolonoscopy |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing screening colonoscopy
Key exclusion criteria (5 listed)
- Age < 50
- Prior colon resection
- Inflammatory bowel disease
- Prior colonoscopy or sigmoidoscopy
- More than one first-degree relative with colon cancer
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 |
|---|---|---|
| ChromocolonoscopyIndigocarmine dye applied to entire colon to highlight mucosal detail and enhance detection of flat lesions. | Procedure or surgery | 1 |
Primary outcome
Prevalence of adenomas detected by chromocolonoscopy versus standard colonoscopy.
Time frame: Cross-sectional prevalence of adenomas between the 2 study groups
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 28 Jan 2009.
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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.
Charles J Kahi, MD principal investigator
Indiana University School of Medicine, Roudebush VA Medical Center, Indianapolis, Indiana
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chromocolonoscopy in people with Colon Cancer and Polyp, run by Indiana University at 3 sites in United States.
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 5 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 28 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Prevalence of adenomas detected by chromocolonoscopy versus standard colonoscopy. (time frame: Cross-sectional prevalence of adenomas between the 2 study groups). 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 28 Jan 2009.