- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03601065
Computer Assisted Detection & Selection of Serrated Adenomas and Neoplastic Polyps - a New Clinical DRAft (CASSANDRA II)
The aim of the study is to develop a computer program which is able to automatically detect colorectal polyps in endoscopic video sequences. Furthermore, the program shall be able to automatically distinguish between adenomas, serrated adenomas and hyperplastic polyps on the basis of optical features of the polyps. Video sequences of polyps will be collected during routine colonoscopy procedures. All polyps will be resected endoscopically so that histopathological diagnoses (gold standard) can be notified.
In the validation phase of the study a computer program will be established which aims to distinguish between adenomas, serrated adenomas and hyperplastic polyps on the basis of optical features derived from the videos. A deep learning approach will be used for programming. Afterwards, in the testing phase of the study, videos of 100 polyps (not used in the validation phase) will be presented to the computer program. The establishment of a well- functioning computer program is the primary aim of the study.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Adenomas are polyps of the colorectum that have the potential to develop into colon cancer [1]. However, some adenomas never become malignant and if they do, progression from adenoma into cancer usually takes a long time. As a result, screening colonoscopy programs were established in order to detect and resect adenomas at an early stage [2]. After resection, polyps should be sent to pathology in order to make a histological diagnosis. Not every colorectal polyp has adenomatous histology. Approximately 40-50% of all polyps contain other benign histology (e.g. hyperplastic polyps). These polyps do not bear the risk of colon cancer.
The implementation of screening programs has led to increasing numbers of colonoscopies in the last years [3]. This approach naturally implies higher amounts of detected polyps. The removal of these polyps and consultation of a pathologist in order to make a diagnosis is time consuming and expensive. An optical- based prediction of polyp histology (adenomatous versus non- adenomatous) would enable endoscopists to save money and to inform patients faster about examination results. The approach of predicting polyp histology on the basis of optical features is called the "optical biopsy" method. The prediction is made by the endoscopists during real-time colonoscopy. The aim of this strategy is to make an optical diagnosis which enables users to resect polyps without sending the specimen to pathology. Narrow Band Imaging (NBI) is a light-filter device which can be switched on during colonoscopy. NBI is useful to better display vascular patterns of the colon mucosa. It has been shown that the use of NBI can facilitate optical classification of colorectal polyps [5]. A NBI- based classification schemes exists which can be used to assign polyps into specific polyp categories (adenomatous versus non- adenomatous) [6].
Prior to the implementation of the optical classification approach for routine use in endoscopy it is necessary to proof its feasibility and accuracy [7]. Otherwise the approach would entail the risk of wrong diagnoses which could lead to wrong recommendations on further diagnostic or therapeutic steps.
Until now, some clinical trials have shown good accuracy for the optical biopsy method [5]. However, there is growing evidence that optical biopsy does not yet meet demanded accuracy thresholds [8]. The aim of our study is to create a computer program that is able to distinguish between adenomas, serrated adenomas and hyperplastic polyps. Video sequences of colorectal polyps will be used for machine learning (validation phase). Afterwards a set of 100 videos will be used to test whether the computer program is able to distinguish between adenomatous and non- adenomatous polyps (primary endpoint). Statistical measures (accuracy, sensitivity, specificity) will be calculated. The 100 videos will also be presented to human experts who will also predict polyp diagnoses based on optical features. Comparing the accuracy of optical predictions made by the computer and by human experts will be another endpoint of the study.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Peter Klare, MD
- Phone Number: 9340 +49 89 4140
- Email: peter.klare@tum.de
Study Locations
-
-
-
Munich, Germany, 81675
- Klinik für Innere Medizin II am Klinikum rechts der Isar der Technischen Universität München München, Deutschland Germany
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- indication for colonoscopy
- patients >= 18 years
Exclusion Criteria:
- pregnant women
- indication for colonoscopy: inflammatory bowel disease
- indication for colonoscopy: emergency colonoscopy e.g. acute bleeding
- contraindication for polyp resection e.g. patients on warfarin
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Routine colonoscopy Cohort
|
Ther is no study specific intervention.
Video sequences will be taken if polyps are found in the colon.
Polyps will then be resected routinely.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assessment of the computer- made optical diagnosis of each colorectal polyp
Time Frame: up to 2 weeks
|
The predicted polyp histology (made optically by the computer program) will be assessed; the predicted diagnosis will be compared with the histopathological diagnosis (gold standard) after resection of the polyp; (participants will be followed for the duration of hospital stay or outpatient treatment, an expected average of 2 weeks)] [Safety Issue: No] After obtaining the histopathological diagnosis of resected polyps (approximately 3 days - 2 weeks) |
up to 2 weeks
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Hewett DG, Kaltenbach T, Sano Y, Tanaka S, Saunders BP, Ponchon T, Soetikno R, Rex DK. Validation of a simple classification system for endoscopic diagnosis of small colorectal polyps using narrow-band imaging. Gastroenterology. 2012 Sep;143(3):599-607.e1. doi: 10.1053/j.gastro.2012.05.006. Epub 2012 May 15.
- Vogelstein B, Fearon ER, Hamilton SR, Kern SE, Preisinger AC, Leppert M, Nakamura Y, White R, Smits AM, Bos JL. Genetic alterations during colorectal-tumor development. N Engl J Med. 1988 Sep 1;319(9):525-32. doi: 10.1056/NEJM198809013190901.
- Kaminski MF, Hassan C, Bisschops R, Pohl J, Pellise M, Dekker E, Ignjatovic-Wilson A, Hoffman A, Longcroft-Wheaton G, Heresbach D, Dumonceau JM, East JE. Advanced imaging for detection and differentiation of colorectal neoplasia: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2014 May;46(5):435-49. doi: 10.1055/s-0034-1365348. Epub 2014 Mar 17.
- ASGE Technology Committee; Abu Dayyeh BK, Thosani N, Konda V, Wallace MB, Rex DK, Chauhan SS, Hwang JH, Komanduri S, Manfredi M, Maple JT, Murad FM, Siddiqui UD, Banerjee S. ASGE Technology Committee systematic review and meta-analysis assessing the ASGE PIVI thresholds for adopting real-time endoscopic assessment of the histology of diminutive colorectal polyps. Gastrointest Endosc. 2015 Mar;81(3):502.e1-502.e16. doi: 10.1016/j.gie.2014.12.022. Epub 2015 Jan 16.
- Brenner H, Altenhofen L, Stock C, Hoffmeister M. Prevention, early detection, and overdiagnosis of colorectal cancer within 10 years of screening colonoscopy in Germany. Clin Gastroenterol Hepatol. 2015 Apr;13(4):717-23. doi: 10.1016/j.cgh.2014.08.036. Epub 2014 Sep 15.
- Stock C, Haug U, Brenner H. Population-based prevalence estimates of history of colonoscopy or sigmoidoscopy: review and analysis of recent trends. Gastrointest Endosc. 2010 Feb;71(2):366-381.e2. doi: 10.1016/j.gie.2009.06.018. Epub 2009 Oct 20.
- Lopez-Ceron M, Sanabria E, Pellise M. Colonic polyps: is it useful to characterize them with advanced endoscopy? World J Gastroenterol. 2014 Jul 14;20(26):8449-57. doi: 10.3748/wjg.v20.i26.8449.
- Kang HY, Kim YS, Kang SJ, Chung GE, Song JH, Yang SY, Lim SH, Kim D, Kim JS. Comparison of Narrow Band Imaging and Fujinon Intelligent Color Enhancement in Predicting Small Colorectal Polyp Histology. Dig Dis Sci. 2015 Sep;60(9):2777-84. doi: 10.1007/s10620-015-3661-5. Epub 2015 Apr 14.
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CASSANDRA II
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colonic Polyps
-
VA Greater Los Angeles Healthcare SystemTerminatedScreening of Colonic PolypsUnited States
-
Princess Alexandra Hospital, Brisbane, AustraliaRecruiting
-
Chinese University of Hong KongRecruitingColonic PolypHong Kong
-
Sengkang General HospitalMedtronicRecruiting
-
Haraldsplass Deaconess HospitalHaukeland University Hospital; Kanalspesialistene AS; European Society of Gastrointestinal...Recruiting
-
Affiliated Hospital to Academy of Military Medical...Completed
-
Chinese University of Hong KongCompleted
-
London North West Healthcare NHS TrustCompletedColonic PolypUnited Kingdom
-
Nuovo Regina Margherita HospitalCompleted
-
Shaare Zedek Medical CenterGoogle LLC.CompletedColonic PolypIsrael
Clinical Trials on Videos of polyps, resection of polyps
-
Technical University of MunichUnknown
-
Ullevaal University HospitalCompletedEndometrial Cancer | Endometrial PolypNorway
-
Isabel Bejerano BlázquezHospital Universitario Reina Sofia de Cordoba; Universidad Nacional de CórdobaCompleted
-
Ullevaal University HospitalUnknown
-
Kyunghee University Medical CenterCompletedPolyp of Large IntestineKorea, Republic of
-
Gabriel RAHMICompletedColorectal PolypsFrance
-
Midwest Biomedical Research FoundationNot yet recruitingIdentification of Colorectal Polyps
-
University of Erlangen-Nürnberg Medical SchoolUnknown
-
University Hospital, GhentCompletedAssessment of the Blink (First) Impression Regarding the Presence of Cancer Within Colorectal PolypsColorectal Cancer | Colorectal Polyp | ColonoBelgium
-
Portsmouth Hospitals NHS TrustCompletedColonic PolypsUnited Kingdom