Colonic PolypsNCT02522702
Computer Assisted Optical Assessment of Small Colorectal Polyps
An observational study of Colonic Polyps, run by Technical University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Polyps
- What is being tested?
- Photography of polyps, resection of polyps
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2015to Aug 2017
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing routine colonoscopy
Who may be able to join
- indication for colonoscopy
- patients >= 18 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
II Medizinische Klinik am Klinikum rechts der Isar der Technischen Universität München München, Deutschland Germany
Munich, 81675
About this study
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.
Read the 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 or inflammatory 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 adenomatous and non-adenomatous polyps. Still images of colorectal polyps including NBI- pictures of polyps will be used for machine learning (validation phase). Afterwards a set of 100 still pictures 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.
- Conditions
- Colonic Polyps
- Being tested
- Photography of polyps, resection of polyps
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Routine colonoscopy Cohort | Not described Receives: Other: Photography of polyps, resection of polyps |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2015 (estimated)
- Study startAug 2015
- Primary completionJan 2017
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Colonic PolypsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Peter Klare, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02522702
- Sponsor's protocol ID
- COACH
- Status last verified
- Apr 2017
- First submitted
- 8 Aug 2015
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 2841597Brenner 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.
PubMed 25218160Stock 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.
PubMed 19846082Lopez-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.
PubMed 25024601ASGE 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.
PubMed 25597420Hewett 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.
PubMed 22609383Kaminski 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.
PubMed 24639382Kang 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.
PubMed 25868634
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Assisted Optical Assessment of Small Colorectal Polyps
- ClinicalTrials.gov ID
- NCT02522702
- Acronym / sponsor ID
- COACH
- Conditions
- Colonic Polyps
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Aug 2017 (estimated)
- First posted
- 13 Aug 2015 (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.
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.
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 or inflammatory 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 adenomatous and non-adenomatous polyps. Still images of colorectal polyps including NBI- pictures of polyps will be used for machine learning (validation phase). Afterwards a set of 100 still pictures 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Routine colonoscopy Cohort | – | Other: Photography of polyps, resection of polyps |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing routine colonoscopy
Key inclusion criteria (2 listed)
- indication for colonoscopy
- patients >= 18 years
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Photography of polyps, resection of polypsTher is no study specific intervention. Still images will be taken if polyps are found in the colon. Polyps will then be resected routinely. | Other | Routine colonoscopy Cohort |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Background: PubMed 2841597Vogelstein 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.
- Background: PubMed 25218160Brenner 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.
- Background: PubMed 19846082Stock 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.
- Background: PubMed 25024601Lopez-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.
- Background: PubMed 25597420ASGE 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.
- Background: PubMed 22609383Hewett 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.
- Background: PubMed 24639382Kaminski 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.
- Background: PubMed 25868634Kang 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.
Related trials for Colonic Polyps
Recruiting
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
Colonic Neoplasms
RecruitingObservational study
KLF4 Epigenetic Modulation
KLF4 Methylation, Epigenetic
RecruitingObservational study
Malignant Polyp Registry
Malignant Colorectal Polyp, Colorectal Cancer
Active, not recruiting
Virtual Incision Robotically Assisted Surgical Device Use in Minimally Invasive Colectomy
Colon Cancer, Colon Polyp
Enrolling by invitation
Cold Snare Piecemeal Resection vs Cold Snare Endoscopic Mucosal Resection
Colon Polyp, Colon Adenoma
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colonic Polyps, run by Technical University of Munich 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 Apr 2017. 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.
Are results available for this study?
Results are not available in the source record.
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?
Assessment of the computer- made optical diagnosis of each colorectal polyp (time frame: up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02522702, which also lists 8 linked publications.
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 11 Apr 2017.