Ulcerative ColitisPhase 3NCT00352404
Chromoscopic Guided Endomicroscpy to Diagnose Colitis Associated Dysplasia
A Phase 3 study testing Endomicroscope in people with Ulcerative Colitis and Intraepithelial Neoplasia, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
Timely diagnosis of intraepithelial neoplasias (premalignant condition)is of crucial importance for clinical management of ulcerative colitis. We assessed the value of combined chromoscopy and endomicroscopy for diagnosis of intraepithelial neoplasias in a randomised controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ulcerative Colitis, Intraepithelial Neoplasia, Cancer
- What is being tested?
- Endomicroscope
- Type of treatment
- Medical device
- How many people
- 114 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2003to Nov 2004
- Phase
- Phase 3
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically and histologically verified UC
- Disease duration >8 years
- Colitis Activity Index ≤8
- Activity index of Truelove and Witts: mild
Who cannot join
- Known intraepithelial neoplasia or colorectal cancer
- Coagulopathy (Prothrombin time <50% of control, Partial thromboplastin time >50 s)
- Impaired renal function (Creatinine >1.2 mg/dL)
- Pregnancy or breast feeding
- Inability to obtain informed consent
- Known allergy to methylene blue or Fluorescein
Trial locations and contacts
1 site in 1 country.
Germany1 site
I. Med. Klinik, Johannes Gutenberg Universitaet
Mainz, Rhineland-Palatinate, 55131
About this study
Official title: Diagnosis of Intraepithelial Neoplasia in Patients With Long Standing Ulcerative Colitis With Chromoscopic Guided Endomicroscopy
Timely diagnosis of intraepithelial neoplasias (premalignant condition)is of crucial importance for clinical management of ulcerative colitis. We assessed the value of combined chromoscopy and endomicroscopy for diagnosis of intraepithelial neoplasias in a randomised controlled trial.
Endomicroscopy is a new device which enables microscopy of the mucosal layer during ongoing colonoscopy. Chromoscopy means topical staining of mucosal surface to unmask areas of interest, which are subsequently examined with the endomicroscopic system.
Read the detailed description
Ulcerative colitis (UC) is an immune cell-mediated inflammatory bowel disease characterized by mucosal ulcerations, rectal bleeding, diarrhea, and abdominal pain. Patients with long standing UC face an increased risk for development of colitis associated colorectal cancer. Factors associated with increased risk for cancer development include the duration of the disease, extensive colonic involvement (pancolitis, backwash ileitis), primary sclerosing cholangitis and severe chronic active inflammation. Based on these observations, colonoscopic surveillance in patients with long-standing UC is highly recommended.
The main objective of surveillance colonoscopy in UC is to detect neoplasia at a surgically curative and preferably pre-invasive stage. However, in contrast to sporadic colorectal cancer, the growing pattern of neoplastic tissue in UC is often flat and multifocal. Therefore, significant lesions during conventional colonoscopy in UC are frequently overlooked. Chromoscopy with topically applied dyes such as methylene blue or indigo carmine facilitates the endoscopic detection of flat, circumscribed colitis associated neoplastic changes in UC. In fact, five controlled studies showed that the diagnostic yield for the detection of intraepithelial neoplasia (IN) using chromoscopy is higher as compared to conventional colonoscopy with random biopsies. Based on the above studies, chromoscopy has recently been considered for incorporation into US guidelines for surveillance of patients with long-standing UC. However, although this technique does allow identification of mucosal lesions, it is not suitable for accurate endoscopic diagnosis of intraepithelial neoplasias in UC due to the lack of cellular resolution and subsurface imaging. For endoscopy, novel techniques allowing accurate diagnoses during ongoing examination are highly desirable and may allow appropriate and immediate therapeutic manoeuvres (e.g. resection versus biopsy). Recently, a miniaturized confocal microscope has been developed integrated in the distal tip of a conventional colonoscope . This new diagnostic technology for gastrointestinal endoscopy, denoted confocal endomicroscopy, enables histological evaluation of the mucosal layer during ongoing colonoscopy. Furthermore, in patients screened for sporadic colorectal cancer, surface and subsurface analysis at cellular and subcellular resolution can be used to predict intraepithelial neoplasias (INs) with high accuracy. However, due to the time required for examination of large surface areas, this technique is not suitable for screening of the entire colonic surface in UC to detect neoplasias in flat mucosa.
In the present study, we employ chromoscopy to identify potential neoplastic lesions and combine this for the first time with endomicroscopy for the endoscopic diagnosis of colitis associated intraepithelial neoplasias in UC. Using such chromoscopy guided endomicroscopy we will ecaluate whether the diagnostic yield diagnosing IN can be significantly increased.
- Conditions
- Ulcerative Colitis, Intraepithelial Neoplasia, Cancer
- Being tested
- Endomicroscope
- Keywords
- Endomicroscopy, Chromoendoscopy, Chromoscopy, Ulcerative Colitis, Intraepithelial Neoplasia
- Medical subject headings
- Colitis, Ulcerative, Carcinoma in Situ, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EndomicroscopeDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological proof of neoplastic tissue (Intraepithelial neoplasia or cancer)
Secondary outcomes (1)
Prediction of extent and severity of inflamed mucosa
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2006 (estimated)
- Study startAug 2003
- Study completionNov 2004
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 114 participants
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Investigators
- Peter R. Galle, MD PhD, Study director, Johannes Gutenberg University, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00352404
- Sponsor's protocol ID
- DE 000043385
- Status last verified
- Aug 2003
- First submitted
- 13 Jul 2006
- Last updated
- 14 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnosis of Intraepithelial Neoplasia in Patients With Long Standing Ulcerative Colitis With Chromoscopic Guided Endomicroscopy
- ClinicalTrials.gov ID
- NCT00352404
- Acronym / sponsor ID
- DE 000043385
- Conditions
- Ulcerative Colitis, Intraepithelial Neoplasia, Cancer
- Keywords
- Endomicroscopy, Chromoendoscopy, Chromoscopy, Ulcerative Colitis, Intraepithelial Neoplasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Aug 2003
- Study completion
- Nov 2004
- First posted
- 14 Jul 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.
Timely diagnosis of intraepithelial neoplasias (premalignant condition)is of crucial importance for clinical management of ulcerative colitis. We assessed the value of combined chromoscopy and endomicroscopy for diagnosis of intraepithelial neoplasias in a randomised controlled trial.
Endomicroscopy is a new device which enables microscopy of the mucosal layer during ongoing colonoscopy. Chromoscopy means topical staining of mucosal surface to unmask areas of interest, which are subsequently examined with the endomicroscopic system.
Detailed description
Ulcerative colitis (UC) is an immune cell-mediated inflammatory bowel disease characterized by mucosal ulcerations, rectal bleeding, diarrhea, and abdominal pain. Patients with long standing UC face an increased risk for development of colitis associated colorectal cancer. Factors associated with increased risk for cancer development include the duration of the disease, extensive colonic involvement (pancolitis, backwash ileitis), primary sclerosing cholangitis and severe chronic active inflammation. Based on these observations, colonoscopic surveillance in patients with long-standing UC is highly recommended.
The main objective of surveillance colonoscopy in UC is to detect neoplasia at a surgically curative and preferably pre-invasive stage. However, in contrast to sporadic colorectal cancer, the growing pattern of neoplastic tissue in UC is often flat and multifocal. Therefore, significant lesions during conventional colonoscopy in UC are frequently overlooked. Chromoscopy with topically applied dyes such as methylene blue or indigo carmine facilitates the endoscopic detection of flat, circumscribed colitis associated neoplastic changes in UC. In fact, five controlled studies showed that the diagnostic yield for the detection of intraepithelial neoplasia (IN) using chromoscopy is higher as compared to conventional colonoscopy with random biopsies. Based on the above studies, chromoscopy has recently been considered for incorporation into US guidelines for surveillance of patients with long-standing UC. However, although this technique does allow identification of mucosal lesions, it is not suitable for accurate endoscopic diagnosis of intraepithelial neoplasias in UC due to the lack of cellular resolution and subsurface imaging. For endoscopy, novel techniques allowing accurate diagnoses during ongoing examination are highly desirable and may allow appropriate and immediate therapeutic manoeuvres (e.g. resection versus biopsy). Recently, a miniaturized confocal microscope has been developed integrated in the distal tip of a conventional colonoscope . This new diagnostic technology for gastrointestinal endoscopy, denoted confocal endomicroscopy, enables histological evaluation of the mucosal layer during ongoing colonoscopy. Furthermore, in patients screened for sporadic colorectal cancer, surface and subsurface analysis at cellular and subcellular resolution can be used to predict intraepithelial neoplasias (INs) with high accuracy. However, due to the time required for examination of large surface areas, this technique is not suitable for screening of the entire colonic surface in UC to detect neoplasias in flat mucosa.
In the present study, we employ chromoscopy to identify potential neoplastic lesions and combine this for the first time with endomicroscopy for the endoscopic diagnosis of colitis associated intraepithelial neoplasias in UC. Using such chromoscopy guided endomicroscopy we will ecaluate whether the diagnostic yield diagnosing IN can be significantly increased.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinically and histologically verified UC
- Disease duration >8 years
- Colitis Activity Index ≤8
- Activity index of Truelove and Witts: mild
Key exclusion criteria (6 listed)
- Known intraepithelial neoplasia or colorectal cancer
- Coagulopathy (Prothrombin time <50% of control, Partial thromboplastin time >50 s)
- Impaired renal function (Creatinine >1.2 mg/dL)
- Pregnancy or breast feeding
- Inability to obtain 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 |
|---|---|---|
| Endomicroscope | Device | – |
Primary outcome
Histological proof of neoplastic tissue (Intraepithelial neoplasia or cancer)
1 secondary outcome
Prediction of extent and severity of inflamed mucosa
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 14 Jul 2006.
- Information about the new deviceLink provided by the sponsor.
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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.
Peter R. Galle, MD PhD study director
Johannes Gutenberg University, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Endomicroscope in people with Ulcerative Colitis and Intraepithelial Neoplasia, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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 6 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 14 Jul 2006. 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 Germany. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Histological proof of neoplastic tissue (Intraepithelial neoplasia or cancer). 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 14 Jul 2006.