Brief Summary

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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

250

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Aug 2018

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.2 years study duration

First Submitted

Initial submission to the registry

July 17, 2018

Completed

9 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed

6 days until next milestone

Study Start

First participant enrolled

August 1, 2018

Completed

11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed

Last Updated

July 26, 2018

Status Verified

July 1, 2018

Enrollment Period

11 months

First QC Date

July 17, 2018

Last Update Submit

July 17, 2018

Conditions

Colonic Polyps

Outcome Measures

Primary Outcomes (1)

Assessment of the computer- made optical diagnosis of each colorectal polyp
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

Study Arms (1)

Routine colonoscopy Cohort

Other: Videos of polyps, resection of polyps

Interventions

Videos of polyps, resection of polypsOTHER

Ther is no study specific intervention. Video sequences will be taken if polyps are found in the colon. Polyps will then be resected routinely.

Routine colonoscopy Cohort

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Patients undergoing routine colonoscopy

You may qualify if:

indication for colonoscopy
patients \>= 18 years

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik für Innere Medizin II am Klinikum rechts der Isar der Technischen Universität München München, Deutschland Germany

Munich, 81675, Germany

Location

Related Publications (8)

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.
PMID: 2841597BACKGROUND
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.
PMID: 25218160BACKGROUND
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.
PMID: 19846082BACKGROUND
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.
PMID: 25024601BACKGROUND
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.
PMID: 25597420BACKGROUND
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.
PMID: 22609383BACKGROUND
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.
PMID: 24639382BACKGROUND
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.
PMID: 25868634BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Colonic Polyps

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal PolypsPolypsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Peter Klare, MD

CONTACT

+49 89 4140 peter.klare@tum.de

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Dr. med. Peter Klare

Study Record Dates

First Submitted

July 17, 2018

First Posted

July 26, 2018

Study Start

August 1, 2018

Primary Completion

July 1, 2019

Study Completion

October 1, 2019

Last Updated

July 26, 2018

Record last verified: 2018-07

Locations

DE(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Routine colonoscopy Cohort

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (8)

Biospecimen

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

Locations