Colorectal CancerNCT04349787
Improving Optical Diagnosis of Colorectal Polyps Using CADx and BASIC.
An observational study of Colorectal Cancer and Colorectal Polyp, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Primary, this study aims to develop and validate a computer-aided diagnosis (CADx) system for the characterization of colorectal polyps. Second, this study evaluates the effect of using a clinical classification model Blue Light Imaging Adenoma Serrated International (BASIC) on the diagnostic accuracy of the optical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Colorectal Polyp
- What is being tested?
- Computer-aided diagnosis (CADx) and BLI Adenoma Serrated International Classification (BASIC)
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- 26 Nov 2019to 8 Mar 2020
- 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 who had a colonoscopy in the Catharina hospital Eindhoven between January 2017 and December 2018 in the context of the regular bowel cancer screening program, in the context of complaints or in the context of the follow-up of previously diagnosed bowel diseases.
Who may be able to join
- Patients with at least one colorectal polyp found and resected during colonoscopy in regular care;
- Availability of at least one high definition white light image and one Blue Light Imaging (BLI) image of the colorectal polyp;
- Overall high quality of the colorectal polyp image;
- Availability of the histological results of the colorectal polyp;
- Minimal age of 18 years old.
Who cannot join
- Objection to participate in medical scientific research, reported in the medical file;
- Endoscopic instruments visible at the colorectal polyp image;
- More than one polyp visible at the colorectal polyp image.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6202AZ
About this study
Official title: Improving Optical Diagnosis of Colorectal Polyps Using Computer-aided Diagnosis (CADx) and the BLI Adenoma Serrated International Classification (BASIC).
Primary, this study aims to develop and validate a computer-aided diagnosis (CADx) system for the characterization of colorectal polyps.
Second, this study evaluates the effect of using a clinical classification model Blue Light Imaging Adenoma Serrated International (BASIC) on the diagnostic accuracy of the optical diagnosis of colorectal polyps compared to intuitive optical diagnosis for both expert endoscopists and novices.
Read the detailed description
Optical diagnosis of colorectal polyps, the in-vivo characterization of the histology by endoscopists, is of increasing interest for clinical endoscopy practice. Recent studies have shown that thresholds for optical diagnosis are met in highly selected groups of expert endoscopists, but the same is not true in community endoscopy practices. In order to improve optical diagnosis, imaging enhancement techniques and the use of artificial intelligence are proposed.
This observational study developes a computer-aided diagnosis (CADx) system to differentiate between benign and (pre-)malignant CRPs, using state-of-the-art machine learning methods and deep learning architectures. For the development, HDWL and BLI images are used. The CADx is trained using histology as gold standard. The CADx is externally validated using on a set of 60 colorectal polyps. This study will evaluate if the optical diagnosis of colorectal polyps can be improved with the aid of CADx.
In addition, both expert endoscopists and novices optically diagnose the colorectal polyps. In the first, pre-training phase, endoscopists optically diagnose colorectal polyps based on intuition. Afterwards, in the post-training phase, the same set of colorectal polyps is optically diagnosed based on a clinical classification system; BLI Adenoma Serrated International Classification (BASIC). This study will evaluate if the optical diagnosis of colorectal polyps can be improved with the aid of BASIC in both expert and non-expert hands.
- Conditions
- Colorectal Cancer, Colorectal Polyp
- Being tested
- Computer-aided diagnosis (CADx), BLI Adenoma Serrated International Classification (BASIC)
- Keywords
- Artificial intelligence, Computer-aided diagnosis, Optical diagnosis, Colorectal polyps, Blue light imaging
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-aided diagnosis (CADx)Other
Optical diagnosis of colorectal polyps made with computer-aided diagnosis (CADx) using state-of-the-art machine learning methods and deep learning architectures.
BLI Adenoma Serrated International Classification (BASIC)Other
Optical diagnosis of colorectal polyps made with BLI Adenoma Serrated International Classification (BASIC), both by exert endoscopists and novices.
| Study group | Role | What they receive |
|---|---|---|
| Colorectal polyp patients | Patients who have a colonoscopy in regular care as part of the Dutch colorectal screening program, in the context of complaints or in the context of the follow-up of previously diagnosed bowel diseases. And who have at least one colorectal polyp found and resected during the examination. Receives: Other: Computer-aided diagnosis (CADx); Other: BLI Adenoma Serrated International Classification (BASIC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of CADx versus endoscopists
The diagnostic accuracy of characterizing colorectal polyps (into benign versus (pre-)malignant) made by CADx in comparison to the diagnostic accuracy of both expert endoscopists and novices. In which histology is the gold standard.
Measured: 6 months
Secondary outcomes (7)
Diagnostic accuracy of BASIC versus intuition
The diagnostic accuracy of both expert endoscopists and novices in characterizing colorectal polyps (into hyperplastic polyp, adenoma, sessile serrated adenoma, or adenocarcinoma) based on the clinical classification model BASIC, in comparison to the diagnostic accuracy based on intuition. In which histology is the gold standard.
Measured: 6 months
Diagnostic metrics of CADx
The sensitivity, specificity, negative and positive predictive value of characterizing colorectal polyps (into benign versus (pre-)malignant) made by CADx.
Measured: 6 months
AUC of CADx
Area Under ROC Curve (AUC) of CADx for characterizing colorectal polyps (into benign versus (pre-)malignant) made by CADx.
Measured: 6 months
Diagnostic metrics of endoscopists
The sensitivity, specificity, negative and positive predictive value of characterizing colorectal polyps (into hyperplastic polyp, adenoma, sessile serrated adenoma, or adenocarcinoma) of both expert endoscopists and novices.
Measured: 6 months
Diagnostic metrics of endoscopists for high confidence diagnosis
The diagnostic accuracy, sensitivity, specificity, negative and positive predictive value of both expert endoscopists and novices for optical diagnosis made with high (>90%) confidence.
Measured: 6 months
Interobserver agreement
The interobserver agreement of experts, novices and CADx for characterizing colorectal polyps.
Measured: 6 months
Computation time of CADx
The computation time per image of CADx for characterizing colorectal polyps.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start26 Nov 2019
- Primary completion8 Mar 2020
- Study completion8 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies 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
- Retrospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Catharina Ziekenhuis Eindhoven, Eindhoven University of Technology
- Responsible party
- Sponsor
- Investigators
- Ad Masclee, Prof. Dr., Principal investigator, Maastricht Universitair Medisch Centrum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349787
- Sponsor's protocol ID
- METC 2019-1231
- Status last verified
- Apr 2020
- First submitted
- 9 Apr 2020
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this moment, there is no plan to share individual participant data.
Publications
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.
PubMed 25597420Subramaniam S, Hayee B, Aepli P, Schoon E, Stefanovic M, Kandiah K, Thayalasekaran S, Alkandari A, Bassett P, Coron E, Pech O, Hassan C, Neumann H, Bisschops R, Repici A, Bhandari P. Optical diagnosis of colorectal polyps with Blue Light Imaging using a new international classification. United European Gastroenterol J. 2019 Mar;7(2):316-325. doi: 10.1177/2050640618822402. Epub 2019 Jan 6.
PubMed 31080616Byrne MF, Chapados N, Soudan F, Oertel C, Linares Perez M, Kelly R, Iqbal N, Chandelier F, Rex DK. Real-time differentiation of adenomatous and hyperplastic diminutive colorectal polyps during analysis of unaltered videos of standard colonoscopy using a deep learning model. Gut. 2019 Jan;68(1):94-100. doi: 10.1136/gutjnl-2017-314547. Epub 2017 Oct 24.
PubMed 29066576van der Zander QEW, Schreuder RM, Fonolla R, Scheeve T, van der Sommen F, Winkens B, Aepli P, Hayee B, Pischel AB, Stefanovic M, Subramaniam S, Bhandari P, de With PHN, Masclee AAM, Schoon EJ. Optical diagnosis of colorectal polyp images using a newly developed computer-aided diagnosis system (CADx) compared with intuitive optical diagnosis. Endoscopy. 2021 Dec;53(12):1219-1226. doi: 10.1055/a-1343-1597. Epub 2021 Mar 10.
PubMed 33368056
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Optical Diagnosis of Colorectal Polyps Using Computer-aided Diagnosis (CADx) and the BLI Adenoma Serrated International Classification (BASIC).
- ClinicalTrials.gov ID
- NCT04349787
- Acronym / sponsor ID
- METC 2019-1231
- Conditions
- Colorectal Cancer, Colorectal Polyp
- Keywords
- Artificial intelligence, Computer-aided diagnosis, Optical diagnosis, Colorectal polyps, Blue light imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Catharina Ziekenhuis Eindhoven, Eindhoven University of Technology
- Study start
- 26 Nov 2019 (actual)
- Primary completion
- 8 Mar 2020 (actual)
- Study completion
- 8 Mar 2020 (actual)
- First posted
- 16 Apr 2020 (actual)
- 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.
Primary, this study aims to develop and validate a computer-aided diagnosis (CADx) system for the characterization of colorectal polyps.
Second, this study evaluates the effect of using a clinical classification model Blue Light Imaging Adenoma Serrated International (BASIC) on the diagnostic accuracy of the optical diagnosis of colorectal polyps compared to intuitive optical diagnosis for both expert endoscopists and novices.
Detailed description
Optical diagnosis of colorectal polyps, the in-vivo characterization of the histology by endoscopists, is of increasing interest for clinical endoscopy practice. Recent studies have shown that thresholds for optical diagnosis are met in highly selected groups of expert endoscopists, but the same is not true in community endoscopy practices. In order to improve optical diagnosis, imaging enhancement techniques and the use of artificial intelligence are proposed.
This observational study developes a computer-aided diagnosis (CADx) system to differentiate between benign and (pre-)malignant CRPs, using state-of-the-art machine learning methods and deep learning architectures. For the development, HDWL and BLI images are used. The CADx is trained using histology as gold standard. The CADx is externally validated using on a set of 60 colorectal polyps. This study will evaluate if the optical diagnosis of colorectal polyps can be improved with the aid of CADx.
In addition, both expert endoscopists and novices optically diagnose the colorectal polyps. In the first, pre-training phase, endoscopists optically diagnose colorectal polyps based on intuition. Afterwards, in the post-training phase, the same set of colorectal polyps is optically diagnosed based on a clinical classification system; BLI Adenoma Serrated International Classification (BASIC). This study will evaluate if the optical diagnosis of colorectal polyps can be improved with the aid of BASIC in both expert and non-expert hands.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal polyp patients | – | Other: Computer-aided diagnosis (CADx), Other: BLI Adenoma Serrated International Classification (BASIC)Patients who have a colonoscopy in regular care as part of the Dutch colorectal screening program, in the context of complaints or in the context of the follow-up of previously diagnosed bowel diseases. And who have at least one colorectal polyp found and resected during the examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who had a colonoscopy in the Catharina hospital Eindhoven between January 2017 and December 2018 in the context of the regular bowel cancer screening program, in the context of complaints or in the context of the follow-up of previously diagnosed bowel diseases.
Key inclusion criteria (5 listed)
- Patients with at least one colorectal polyp found and resected during colonoscopy in regular care;
- Availability of at least one high definition white light image and one Blue Light Imaging (BLI) image of the colorectal polyp;
- Overall high quality of the colorectal polyp image;
- Availability of the histological results of the colorectal polyp;
- Minimal age of 18 years old.
Key exclusion criteria (3 listed)
- Objection to participate in medical scientific research, reported in the medical file;
- Endoscopic instruments visible at the colorectal polyp image;
- More than one polyp visible at the colorectal polyp image.
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 |
|---|---|---|
| Computer-aided diagnosis (CADx)Optical diagnosis of colorectal polyps made with computer-aided diagnosis (CADx) using state-of-the-art machine learning methods and deep learning architectures. | Other | Colorectal polyp patients |
| BLI Adenoma Serrated International Classification (BASIC)Optical diagnosis of colorectal polyps made with BLI Adenoma Serrated International Classification (BASIC), both by exert endoscopists and novices. | Other | Colorectal polyp patients |
Primary outcome
Diagnostic accuracy of CADx versus endoscopists
Time frame: 6 months
The diagnostic accuracy of characterizing colorectal polyps (into benign versus (pre-)malignant) made by CADx in comparison to the diagnostic accuracy of both expert endoscopists and novices. In which histology is the gold standard.
7 secondary outcomes
Diagnostic accuracy of BASIC versus intuition
Time frame: 6 months
Diagnostic metrics of CADx
Time frame: 6 months
AUC of CADx
Time frame: 6 months
Diagnostic metrics of endoscopists
Time frame: 6 months
Diagnostic metrics of endoscopists for high confidence diagnosis
Time frame: 6 months
Interobserver agreement
Time frame: 6 months
Computation time of CADx
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
- 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 31080616Subramaniam S, Hayee B, Aepli P, Schoon E, Stefanovic M, Kandiah K, Thayalasekaran S, Alkandari A, Bassett P, Coron E, Pech O, Hassan C, Neumann H, Bisschops R, Repici A, Bhandari P. Optical diagnosis of colorectal polyps with Blue Light Imaging using a new international classification. United European Gastroenterol J. 2019 Mar;7(2):316-325. doi: 10.1177/2050640618822402. Epub 2019 Jan 6.
- Background: PubMed 29066576Byrne MF, Chapados N, Soudan F, Oertel C, Linares Perez M, Kelly R, Iqbal N, Chandelier F, Rex DK. Real-time differentiation of adenomatous and hyperplastic diminutive colorectal polyps during analysis of unaltered videos of standard colonoscopy using a deep learning model. Gut. 2019 Jan;68(1):94-100. doi: 10.1136/gutjnl-2017-314547. Epub 2017 Oct 24.
- Derived from this study: PubMed 33368056van der Zander QEW, Schreuder RM, Fonolla R, Scheeve T, van der Sommen F, Winkens B, Aepli P, Hayee B, Pischel AB, Stefanovic M, Subramaniam S, Bhandari P, de With PHN, Masclee AAM, Schoon EJ. Optical diagnosis of colorectal polyp images using a newly developed computer-aided diagnosis system (CADx) compared with intuitive optical diagnosis. Endoscopy. 2021 Dec;53(12):1219-1226. doi: 10.1055/a-1343-1597. Epub 2021 Mar 10.
- Individual participant dataSharing planned: No. At this moment, there is no plan to share individual participant data.
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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.
Ad Masclee, Prof. Dr. principal investigator
Maastricht Universitair Medisch Centrum
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 Colorectal Cancer and Colorectal Polyp, run by Maastricht University Medical Center at 1 site in Netherlands.
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 5 inclusion and 3 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: finished, as of the sponsor's last update on 16 Apr 2020. 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 Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnostic accuracy of CADx versus endoscopists (time frame: 6 months). 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 NCT04349787, which also lists 4 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 16 Apr 2020.