Ulcerative ColitisNCT02772406
Linked Color Imaging vs. White Light for Colorectal Dysplasia in Ulcerative Colitis
A study testing Linked Color Imaging and white light imaging in people with Ulcerative Colitis, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
Trial summary
The purpose of the study is to determine whether a new colonoscopic viewing technique called Linked color imaging(LCI) helps endoscopists detect more dysplasia lesions in ulcerative colitis patients than conventional colonoscopy using white light alone. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Linked Color Imaging and white light imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Apr 2016to Dec 2016
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria:patients with ulcerative colitis who meet surveillance criteria Exclusion Criteria:pregnant patients,unable or unwilling to give informed consent,patients with severe active colitis who would be unsafe to endoscope
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital to Academy of Military Medical Sciences
Beijing, Beijing Municipality, 100853
Min Min, M.D.,Ph.D., +86-010-66947473, minmin823@sina.com
About this study
Official title: Linked Color Imaging (LCI) Versus White Light for the Detection of Colorectal Dysplasia in Ulcerative Colitis
The purpose of the study is to determine whether a new colonoscopic viewing technique called Linked color imaging(LCI) helps endoscopists detect more dysplasia lesions in ulcerative colitis patients than conventional colonoscopy using white light alone.
Read the detailed description
Patients with longstanding IBD have increased risk of colorectal cancer (CRC) compared to the general population. The association between duration of the disease and development of CRC is the rationale for endoscopic surveillance. Colonoscopic surveillance of ulcerative colitis patients has been shown to reduce the risk of colorectal cancer and allow detection at an earlier stage, but even with meticulous examination, some precancerous lesions or cancers are missed. The newly developed LCI system (FUJIFILM Co.) creates clear and bright endoscopic images by using short-wavelength narrow-band laser light combined with white laser light on the basis of BLI technology. LCI makes red areas appear redder and white areas appear whiter. Thus, it is easier to recognize a slight difference in color of the mucosa. This is a study to determine if using Linked color imaging (LCI) of the colon, rather than the usual white light on the colon, will improve the detection of more dysplasia lesions in ulcerative colitis.
- Conditions
- Ulcerative Colitis
- Being tested
- Linked Color Imaging, white light imaging
- Keywords
- ulcerative colitis, colonoscopy, Dysplasia, Diagnosis
- Medical subject headings
- Colitis, Ulcerative, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linked Color ImagingDevice
white light imagingDevice
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | (With LCI endoscopy and 1 month later with white light endoscopy) The patients will be evaluated by Linked Color Imaging and 1 month later evaluated by White Light endoscopy Receives: Device: Linked Color Imaging |
| Control group | Active comparator | (With white light endoscopy and 1 month later with LCI endoscopy) The patients will be evaluated by White Light endoscopy and 1 month later evaluated by Linked Color Imaging Receives: Device: white light imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of Colorectal Dysplasia detected by LCI
Measured: 6 months
Secondary outcomes (1)
The endoscopic scores with LCI
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 posted13 May 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Liu, M.D.,Ph.D., Principal investigator, Affiliated Hospital to Academy of Military Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02772406
- Sponsor's protocol ID
- 307-LCI-003
- Status last verified
- May 2016
- First submitted
- 12 May 2016
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Leifeld L, Rogler G, Stallmach A, Schmidt C, Zuber-Jerger I, Hartmann F, Plauth M, Drabik A, Hofstadter F, Dienes HP, Kruis W; Detect Dysplasia Study Group. White-Light or Narrow-Band Imaging Colonoscopy in Surveillance of Ulcerative Colitis: A Prospective Multicenter Study. Clin Gastroenterol Hepatol. 2015 Oct;13(10):1776-1781.e1. doi: 10.1016/j.cgh.2015.04.172. Epub 2015 May 5.
PubMed 25952309
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linked Color Imaging (LCI) Versus White Light for the Detection of Colorectal Dysplasia in Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT02772406
- Acronym / sponsor ID
- 307-LCI-003
- Conditions
- Ulcerative Colitis
- Keywords
- ulcerative colitis, colonoscopy, Dysplasia, Diagnosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 13 May 2016 (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 purpose of the study is to determine whether a new colonoscopic viewing technique called Linked color imaging(LCI) helps endoscopists detect more dysplasia lesions in ulcerative colitis patients than conventional colonoscopy using white light alone.
Detailed description
Patients with longstanding IBD have increased risk of colorectal cancer (CRC) compared to the general population. The association between duration of the disease and development of CRC is the rationale for endoscopic surveillance. Colonoscopic surveillance of ulcerative colitis patients has been shown to reduce the risk of colorectal cancer and allow detection at an earlier stage, but even with meticulous examination, some precancerous lesions or cancers are missed. The newly developed LCI system (FUJIFILM Co.) creates clear and bright endoscopic images by using short-wavelength narrow-band laser light combined with white laser light on the basis of BLI technology. LCI makes red areas appear redder and white areas appear whiter. Thus, it is easier to recognize a slight difference in color of the mucosa. This is a study to determine if using Linked color imaging (LCI) of the colon, rather than the usual white light on the colon, will improve the detection of more dysplasia lesions in ulcerative colitis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: Linked Color Imaging(With LCI endoscopy and 1 month later with white light endoscopy) The patients will be evaluated by Linked Color Imaging and 1 month later evaluated by White Light endoscopy |
| Control group | Active comparator | Device: white light imaging(With white light endoscopy and 1 month later with LCI endoscopy) The patients will be evaluated by White Light endoscopy and 1 month later evaluated by Linked Color Imaging |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Linked Color Imaging | Device | Experimental group |
| white light imaging | Device | Control group |
Primary outcome
The number of Colorectal Dysplasia detected by LCI
Time frame: 6 months
1 secondary outcome
The endoscopic scores with LCI
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Results publication: PubMed 25952309Leifeld L, Rogler G, Stallmach A, Schmidt C, Zuber-Jerger I, Hartmann F, Plauth M, Drabik A, Hofstadter F, Dienes HP, Kruis W; Detect Dysplasia Study Group. White-Light or Narrow-Band Imaging Colonoscopy in Surveillance of Ulcerative Colitis: A Prospective Multicenter Study. Clin Gastroenterol Hepatol. 2015 Oct;13(10):1776-1781.e1. doi: 10.1016/j.cgh.2015.04.172. Epub 2015 May 5.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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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.
Yan Liu, M.D.,Ph.D. principal investigator
Affiliated Hospital to Academy of Military Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Linked Color Imaging and white light imaging in people with Ulcerative Colitis, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 13 May 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Min, M.D.,Ph.D. (+86-010-66947473, minmin823@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of Colorectal Dysplasia detected by LCI (time frame: 6 months). 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 NCT02772406, which also lists 1 linked publication.
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 13 May 2016.