NCT02522702

Brief Summary

The aim of the study is to develop a computer program which is able to distinguish between adenomatous and non- adenomatous polyps on the basis of optical features of the polyps. Still images of polyps (\< 10 mm of size) 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 adenomatous and non- adenomatous polyps on the basis of optical features derived from still images. The program will operated using the the random forest learning method. Afterwards, in the testing phase of the study, still images 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

43
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 2015

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

Study Start

First participant enrolled

August 1, 2015

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 13, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

1.4 years

First QC Date

August 8, 2015

Last Update Submit

April 8, 2017

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: Photography of polyps, resection of polyps

Interventions

Photography of polyps, resection of polypsOTHER

Ther is no study specific intervention. Still images 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: polyposis syndrome
  • 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)

II Medizinische Klinik 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

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

August 8, 2015

First Posted

August 13, 2015

Study Start

August 1, 2015

Primary Completion

January 1, 2017

Study Completion

August 1, 2017

Last Updated

April 11, 2017

Record last verified: 2017-04

Locations

DE(1)