Ulcerative ColitisNCT00274209
Chromoendoscopy for Ulcerative Colitis Surveillance
An observational study of Ulcerative Colitis and Crohn's Disease, run by Indiana University at 1 site in United States.
Trial summary
Long-standing ulcerative colitis is associated with an increased cancer risk. Chromoendoscopy with dye spraying can detect subtle abnormalities that are not visible with standard endoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Crohn's Disease
- What is being tested?
- Chromoendoscopy with magnification
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2005to Nov 2011
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ulcerative colitis satisfying criteria for surveillance colonoscopy
Who may be able to join
- Ulcerative colitis, pancolitis > 8 years; left-sided > 15 years or
- history of PSC or
- history of previous dysplasia on colon biopsies or
- family history of colon cancer in first degree relative
Who cannot join
- any condition that precludes colonoscopy
- expected survival less than 1 year
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Medical Center
Indianapolis, Indiana, 46202
About this study
Official title: Impact of Chromoendoscopy on the Detection of Neoplasia in Ulcerative Colitis
Long-standing ulcerative colitis is associated with an increased cancer risk. Chromoendoscopy with dye spraying can detect subtle abnormalities that are not visible with standard endoscopy. The purpose of this study is to determine if chromoendoscopy with fewer "targeted biopsies" can replace standard colonoscopy with multiple "random" biopsies.
Read the detailed description
Patients with ulcerative colitis (UC) are at increased risk for colon cancer. Current guidelines recommend periodic surveillance colonoscopy in individuals who fulfill certain high-risk criteria. Endoscopists must perform a high number of biopsies (over 33 per patient) in order to increase the yield of such procedures. Chromoendoscopy (CE) has the ability to identify subtle lesions that are otherwise missed by standard endoscopy. Whether CE can replace standard colonoscopy in the surveillance of patients with UC is unknown.
Comparison: both standard biopsies and targeted biopsies will be obtained during colonoscopy from patients with UC who are candidates for surveillance colonoscopy. The yield of the two methods will be compared based on the number of biopsies required to identify one dysplastic (precancerous) lesion.
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Being tested
- Chromoendoscopy with magnification
- Keywords
- Ulcerative colitis, Crohn's disease, Chromoendoscopy, Dysplasia, Neoplasia
- Medical subject headings
- Colitis, Ulcerative, Crohn Disease, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chromoendoscopy with magnificationProcedure or surgery
A blue dye (indigo carmine) will be sprayed prior to imaging the bowel lining using a zoom colonoscope. The dye is not absorbed and is safe for human use.
| Study group | Role | What they receive |
|---|---|---|
| IBD patients at risk for neoplasia | Patients with long-standing ulcerative colitis or Crohn's colitis at risk for neoplasia. Receives: Procedure: Chromoendoscopy with magnification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of dysplastic lesions by white light vs. chromoendoscopy
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2006 (estimated)
- Study startDec 2005
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Chiorean, Indiana University
- Investigators
- Michael V Chiorean, MD, Principal investigator, Indiana University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274209
- Sponsor's protocol ID
- 0509-71
- Status last verified
- Nov 2011
- First submitted
- 6 Jan 2006
- Last updated
- 22 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Chromoendoscopy on the Detection of Neoplasia in Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT00274209
- Acronym / sponsor ID
- 0509-71
- Conditions
- Ulcerative Colitis, Crohn's Disease
- Keywords
- Ulcerative colitis, Crohn's disease, Chromoendoscopy, Dysplasia, Neoplasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 10 Jan 2006 (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.
Long-standing ulcerative colitis is associated with an increased cancer risk. Chromoendoscopy with dye spraying can detect subtle abnormalities that are not visible with standard endoscopy. The purpose of this study is to determine if chromoendoscopy with fewer "targeted biopsies" can replace standard colonoscopy with multiple "random" biopsies.
Detailed description
Patients with ulcerative colitis (UC) are at increased risk for colon cancer. Current guidelines recommend periodic surveillance colonoscopy in individuals who fulfill certain high-risk criteria. Endoscopists must perform a high number of biopsies (over 33 per patient) in order to increase the yield of such procedures. Chromoendoscopy (CE) has the ability to identify subtle lesions that are otherwise missed by standard endoscopy. Whether CE can replace standard colonoscopy in the surveillance of patients with UC is unknown.
Comparison: both standard biopsies and targeted biopsies will be obtained during colonoscopy from patients with UC who are candidates for surveillance colonoscopy. The yield of the two methods will be compared based on the number of biopsies required to identify one dysplastic (precancerous) lesion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBD patients at risk for neoplasia | – | Procedure: Chromoendoscopy with magnificationPatients with long-standing ulcerative colitis or Crohn's colitis at risk for neoplasia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ulcerative colitis satisfying criteria for surveillance colonoscopy
Key inclusion criteria (4 listed)
- Ulcerative colitis, pancolitis > 8 years; left-sided > 15 years or
- history of PSC or
- history of previous dysplasia on colon biopsies or
- family history of colon cancer in first degree relative
Key exclusion criteria (2 listed)
- any condition that precludes colonoscopy
- expected survival less than 1 year
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 |
|---|---|---|
| Chromoendoscopy with magnificationA blue dye (indigo carmine) will be sprayed prior to imaging the bowel lining using a zoom colonoscope. The dye is not absorbed and is safe for human use. | Procedure or surgery | IBD patients at risk for neoplasia |
Primary outcome
Prevalence of dysplastic lesions by white light vs. chromoendoscopy
Time frame: 12 months
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 22 Nov 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.
Michael V Chiorean, MD principal investigator
Indiana University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis and Crohn's Disease, run by Indiana University at 1 site 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 4 inclusion and 2 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 22 Nov 2011. 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 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 dysplastic lesions by white light vs. chromoendoscopy (time frame: 12 months). 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 22 Nov 2011; AzTrials last refreshed its copy on 28 Oct 2026.