SNPMiner Trials (Home Page)
Report for Mutation H180Q
Developed by Shray Alag, 2020.
SNP Clinical Trial Gene
There is one clinical trial.
Clinical Trials
1 Endoscopic Screening for Dysplasia in Patients With Longstanding Ulcerative Colitis: Classical Chromo-endoscopy Versus NBI , FICE and EPK-i.
The risk for colon cancer in patients with longstanding ulcerative colitis exceeding the rectum is increased and therefore patients should be enrolled in a surveillance program eight years after the diagnosis. Until today, official international guidelines for endoscopic screening in patients with ulcerative colitis advise to take 4 biopsies every 10 centimeters (with a minimum of 32) and of each suspected visible lesion. These guidelines are merely based on consensus during expert opinion meetings rather than evidence based. Recent studies have shown that chromo-endoscopy guided biopsies significantly reduced the number of biopsies for each procedure and detected more neoplastic lesions. Chromo-endoscopy is therefore considered the gold standard in this study in which we want to compare it to the performance and efficiency of new endoscopic imaging techniques. Narrow-Band Imaging (NBI) selectively uses certain wavelengths of the visible light leading to a shift in the excitation spectrum towards blue light. The first studies with NBI showed that the additional value of NBI in the detection of neoplastic lesions is comparable to chromo-endoscopy, but time saving and easier to perform. The Fujinon Intelligent Chromo-Endoscopy (FICE) system uses a similar theoretical principal as NBI but this is achieved via the use of post hoc computer algorithms, applying different filters to the stored endoscopic images and enabling a theoretically endless number of combinations of filters that can be used. The Pentax I-scan system also allows post hoc modification of the images. On the one hand, surface enhancement enables to better highlight mucosal changes. Spectral modification allows to apply different modes in analogy with to FICE system. These new imaging techniques have a theoretical advantage which is extendedly used for sales purposes but has however so far not been proven in ulcerative colitis patients. We want to test their clinical use in the screening for neoplastic lesions in patients with long standing ulcerative colitis.
NCT01882205 Ulcerative Colitis Device: Virtual chromoendoscopy Procedure: Chromoendoscopy MeSH:Colitis Colitis, Ulcerative Ulcer
HPO:Colitis Ulcerative colitis
The endoscopes used in the study include the H180Q series of Olympus, the 5000 series of Fujinon and the HD series of Pentax. --- H180Q ---
The endoscopes used do not differ from the ones used in the other randomization arms and include either an Olympus H180Q colonoscope, Fujinon EC 590 ZW/M colonoscope or a Pentax 3890i colonoscope. --- H180Q ---
2. Narrow band imaging with HDTV (Group B) This technique involves an Olympus H180Q colonoscope that is CE approved and commercially available. --- H180Q ---
Primary Outcomes
Description: The primary endpoint will be assessed in three subgroups comparing : 1 )Group A: HDTV Olympus colonoscopes and Chromo-endoscopy, methylene blue 0.1% to Group B: HDTV Olympus colonoscopes and Narrow band Imaging (NBI) 2) Group C: CCD Fujinon colonoscopes and Chromo-endoscopy, methylene blue 0.1% to Group D: CCD Fujinon colonoscopes and Fujinon Intelligent Color Enhancement 3) Group E: HD-Pentax colonoscopes and Chromo-endoscopy, methylene blue 0.1% to Group F: HD Pentax colonoscopes and I-scan As such this is not a comparison between different endoscopy systems, but a comparison of chromoendoscopy and virtual chromoendoscopy within each different system.
Measure: The difference in total number of neoplastic lesions detected by chromoendoscopy and virtual chromoendoscopy Time: The primary endpoint can be assessed when pathology results are available : 2 weeks after endoscopySecondary Outcomes
Description: The total endoscopy time is recorded from the start until the end of the entire procedure. After the caecum is reached, time is recorded. Total retraction time is the time between reaching the caecum and the end of the procedure and includes time for rinsing, dye spraying, biopsy or poliepectomy.
Measure: Duration of total endoscopic procedure time and of endoscopic procedure time during retraction for each technique. Time: The endpoint can be assessed immediately after the endoscopy.Description: The endpoint will be assessed in three subgroups comparing : 1 )Group A: HDTV Olympus colonoscopes and Chromo-endoscopy, methylene blue 0.1% to Group B: HDTV Olympus colonoscopes and Narrow band Imaging (NBI) 2) Group C: CCD Fujinon colonoscopes and Chromo-endoscopy, methylene blue 0.1% to Group D: CCD Fujinon colonoscopes and Fujinon Intelligent Color Enhancement 3) Group E: HD-Pentax colonoscopes and Chromo-endoscopy, methylene blue 0.1% to Group F: HD Pentax colonoscopes and I-scan As such this is not a comparison between different endoscopy systems, but a comparison of chromoendoscopy and virtual chromoendoscopy within each different system.
Measure: The difference in neoplasia detection rate (i.e. the number of patients with at least one neoplastic lesion) between chromoendoscopy and virtual chromoendoscopy. Time: The endpoint can be assessed when pathology results are available : 2 weeks after endoscopyDescription: The endpoint will be assessed in three subgroups comparing : 1 )Group A: HDTV Olympus colonoscopes and Chromo-endoscopy, methylene blue 0.1% to Group B: HDTV Olympus colonoscopes and Narrow band Imaging (NBI) 2) Group C: CCD Fujinon colonoscopes and Chromo-endoscopy, methylene blue 0.1% to Group D: CCD Fujinon colonoscopes and Fujinon Intelligent Color Enhancement 3) Group E: HD-Pentax colonoscopes and Chromo-endoscopy, methylene blue 0.1% to Group F: HD Pentax colonoscopes and I-scan As such this is not a comparison between different endoscopy systems, but a comparison of chromoendoscopy and virtual chromoendoscopy within each different system.
Measure: The difference in the ratio number of neoplastic lesions/ total number of lesions between chromoendoscopy and virtual chromoendoscopy Time: The endpoint can be assessed when pathology results are available : 2 weeks after endoscopyOther Outcomes
Description: The endpoint will be assessed in three subgroups comparing : 1 )Group A: HDTV Olympus colonoscopes and Chromo-endoscopy, methylene blue 0.1% to Group B: HDTV Olympus colonoscopes and Narrow band Imaging (NBI) 2) Group C: CCD Fujinon colonoscopes and Chromo-endoscopy, methylene blue 0.1% to Group D: CCD Fujinon colonoscopes and Fujinon Intelligent Color Enhancement 3) Group E: HD-Pentax colonoscopes and Chromo-endoscopy, methylene blue 0.1% to Group F: HD Pentax colonoscopes and I-scan As such this is not a comparison between different endoscopy systems, but a comparison of chromoendoscopy and virtual chromoendoscopy within each different system.
Measure: The difference in total number of non-neoplastic lesions detected by chromoendoscopy and virtual chromoendoscopy Time: The endpoint can be assessed when pathology results are available : 2 weeks after endoscopyMeasure: Number of biopsies per colonoscopy taken in the different groups. Time: Endpoint can be assessed immediately after endoscopy