Ulcerative ColitisNCT03824418
The Clinical Value of Chromoendoscopy as Surveillance Strategy for Dysplasia Detection in Ulcerative Colitis
An observational study of Ulcerative Colitis and Chromoendoscopy, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
A recent multicentre randomised controlled trial compared autofluorescence imaging (AFI) with CE for dysplasia detection in colonoscopy surveillance of patients with longstanding UC (FIND-UC). In this study, CE detected significantly more dysplastic lesions per patient compared with AFI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Chromoendoscopy
- What is being tested?
- Surveillance colonoscopy with chromoendoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 210 participants
- Where
- 1 siteNetherlands
- Study dates
- 9 May 2016to 1 Oct 2018
- How long will I take part?
- 5 Years
- 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
- Adult, Older adult
Study population: Patients of the FIND-UC trial that undergo a follow surveillance colonoscopy
Who may be able to join
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Patients that where included in the previous FIND-UC trial
Who cannot join
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Patients who not receive their surveillance colonoscopy with CE
- Patients who not undergo their surveillance colonoscopy within 3 months of the surveillance recommendations
- Withdrawal of individual subjects
- A patient will be excluded from the study if any of the following events occur:
- Withdrawal of informed consent
Show all 10Show fewer
- The patient requests to be discontinued from the study
- The bowel preparation is scored as Boston Bowel Preparation Scale <6
- Incomplete colonoscopy because the endoscopist is unable to intubate the cecum during the colonoscopy
- The Mayo-score > 1 in at least in one of the bowel segments
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academic Medical Centre
Amsterdam, North Holland, 1105AZ
About this study
Official title: The Clinical Value of Chromoendoscopy as Surveillance Strategy for Dysplasia Detection in Ulcerative Colitis: an Observational Follow-up Study
A recent multicentre randomised controlled trial compared autofluorescence imaging (AFI) with CE for dysplasia detection in colonoscopy surveillance of patients with longstanding UC (FIND-UC). In this study, CE detected significantly more dysplastic lesions per patient compared with AFI. It is unclear whether this increased dysplasia detection also translates to a reduction of dysplasia at follow-up colonoscopy. The aim of this pre-specified study is therefore to prospectively determine whether there is a difference in dysplasia detection at follow-up colonoscopy between UC patients who were randomized to AFI or CE at index colonoscopy for the FIND-UC trial.
- Conditions
- Ulcerative Colitis, Chromoendoscopy
- Being tested
- Surveillance colonoscopy with chromoendoscopy
- Keywords
- Surveillance, Chromoendoscopy, Dysplasia, Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surveillance colonoscopy with chromoendoscopyProcedure or surgery
Surveillance colonoscopy with chromoendoscopy
| Study group | Role | What they receive |
|---|---|---|
| Chromoendoscopy follow-up | Not described Receives: Procedure: Surveillance colonoscopy with chromoendoscopy | |
| Autofluorescence follow-up | Not described Receives: Procedure: Surveillance colonoscopy with chromoendoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of patients in which at least one histological proven dysplastic lesions was detected at follow-up colonoscopy.
the proportion of patients in which at least one histological proven dysplastic lesions was detected at follow-up colonoscopy.
Measured: during surveillance colonoscopy
Secondary outcomes (5)
The proportion of patients in which at least one histological proven neoplastic lesion was detected
The proportion of patients in which at least one histological proven neoplastic lesion was detected
Measured: during surveillance colonoscopy
The mean number of histological proven neoplastic lesions per patient
The mean number of histological proven neoplastic lesions per patient
Measured: during surveillance colonoscopy
The proportion of patients in which at least one histological proven sessile serrated lesion was detected
The proportion of patients in which at least one histological proven sessile serrated lesion was detected
Measured: during surveillance colonoscopy
The mean number of histological proven sessile serrated lesions per patient
The mean number of histological proven sessile serrated lesions per patient
Measured: during surveillance colonoscopy
Description of dysplasia detected at follow-up colonoscopy (colonic segment, location with respect to a resection scar if visible), or in the resection specimen after proctocolectomy. The proportion of lesions defined as new/missed and recurrent lesion
Description of dysplasia detected at follow-up colonoscopy (colonic segment, location with respect to a resection scar if visible), or in the resection specimen after proctocolectomy. The proportion of lesions defined as new/missed and recurrent lesions detected during surveillance colonoscopy.
Measured: during surveillance colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start9 May 2016
- Primary completion9 May 2018
- Study completion1 Oct 2018
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.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Evelien Dekker, MD, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824418
- Sponsor's protocol ID
- 00001
- Status last verified
- Jan 2019
- First submitted
- 9 Mar 2018
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Value of Chromoendoscopy as Surveillance Strategy for Dysplasia Detection in Ulcerative Colitis: an Observational Follow-up Study
- ClinicalTrials.gov ID
- NCT03824418
- Acronym / sponsor ID
- 00001
- Conditions
- Ulcerative Colitis, Chromoendoscopy
- Keywords
- Surveillance, Chromoendoscopy, Dysplasia, Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 9 May 2016 (actual)
- Primary completion
- 9 May 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 31 Jan 2019 (actual)
- 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.
A recent multicentre randomised controlled trial compared autofluorescence imaging (AFI) with CE for dysplasia detection in colonoscopy surveillance of patients with longstanding UC (FIND-UC). In this study, CE detected significantly more dysplastic lesions per patient compared with AFI. It is unclear whether this increased dysplasia detection also translates to a reduction of dysplasia at follow-up colonoscopy. The aim of this pre-specified study is therefore to prospectively determine whether there is a difference in dysplasia detection at follow-up colonoscopy between UC patients who were randomized to AFI or CE at index colonoscopy for the FIND-UC trial.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chromoendoscopy follow-up | – | Procedure: Surveillance colonoscopy with chromoendoscopy |
| Autofluorescence follow-up | – | Procedure: Surveillance colonoscopy with chromoendoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients of the FIND-UC trial that undergo a follow surveillance colonoscopy
Key inclusion criteria (2 listed)
- In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Patients that where included in the previous FIND-UC trial
Key exclusion criteria (10 listed)
- A potential subject who meets any of the following criteria will be excluded from participation in this study:
- Patients who not receive their surveillance colonoscopy with CE
- Patients who not undergo their surveillance colonoscopy within 3 months of the surveillance recommendations
- Withdrawal of individual subjects
- Withdrawal of informed consent
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 |
|---|---|---|
| Surveillance colonoscopy with chromoendoscopySurveillance colonoscopy with chromoendoscopy | Procedure or surgery | Autofluorescence follow-up, Chromoendoscopy follow-up |
Primary outcome
the proportion of patients in which at least one histological proven dysplastic lesions was detected at follow-up colonoscopy.
Time frame: during surveillance colonoscopy
the proportion of patients in which at least one histological proven dysplastic lesions was detected at follow-up colonoscopy.
5 secondary outcomes
The proportion of patients in which at least one histological proven neoplastic lesion was detected
Time frame: during surveillance colonoscopy
The mean number of histological proven neoplastic lesions per patient
Time frame: during surveillance colonoscopy
The proportion of patients in which at least one histological proven sessile serrated lesion was detected
Time frame: during surveillance colonoscopy
The mean number of histological proven sessile serrated lesions per patient
Time frame: during surveillance colonoscopy
Description of dysplasia detected at follow-up colonoscopy (colonic segment, location with respect to a resection scar if visible), or in the resection specimen after proctocolectomy. The proportion of lesions defined as new/missed and recurrent lesion
Time frame: during surveillance 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 31 Jan 2019.
- Individual participant dataSharing planned: Yes
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Chromoendoscopy, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 2 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: finished, as of the sponsor's last update on 31 Jan 2019. 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 Netherlands. 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?
the proportion of patients in which at least one histological proven dysplastic lesions was detected at follow-up colonoscopy. (time frame: during surveillance 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 31 Jan 2019.