Flat Colorectal LesionAIChallengeMedNCT05942677
Comparison of Flat Colorectal Lesion Detection by Artificial Intelligence-assisted Colonoscopy Versus Endoscopists
An observational study of Flat Colorectal Lesion, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
The development of artificial intelligence (AI) systems in the field of colorectal endoscopy is currently booming, colorectal cancer being, by its frequency and severity, a real public health problem. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Flat Colorectal Lesion
- What is being tested?
- proportion of colorectal lesions
- Type of treatment
- Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2022to 30 Dec 2023
- 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: Every patient referred to our center for colorectal endoscopy for investigation and/or resection of colorectal lesion can join the cohort of this study and will benefit from diagnosis and treatment by experienced endoscopists.
Who may be able to join
- both gender patients even or older than 18 years old
- patient with French Health Insurance coverage
- obtaining of oral non opposition to research after loyal, clear and complete delivery of information
- patients addressed to our center for colorectal lesion resection
- patients presenting a colorectal lesion discovered during a diagnostic colonoscopy
Who cannot join
- patients with health disorders needing short procedure times
- patients with no colorectal lesion
- difficulty continuing colonoscopy due to poor sedation
- difficulty continuing colonoscopy due to a serious adverse event
- inappropriate participation after colonoscopy is completed
- unwillingness to participate after colonoscopy is completed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Flat Colorectal Lesion Detection by Artificial Intelligence-assisted Colonoscopy Versus Endoscopists: AIChallenge - Medtronic
The development of artificial intelligence (AI) systems in the field of colorectal endoscopy is currently booming, colorectal cancer being, by its frequency and severity, a real public health problem.
In terms of image analysis, AI is indeed able to perform many tasks simultaneously (lesion detection, classification, and segmentation) and to combine them.
Read more
Lesion detection is thus the starting point of the whole chain to choose at the end the most appropriate treatment for the patient. Large-scale studies have demonstrated the superiority of artificial intelligence-assisted detection over the usual detection by gastroenterologists, mainly for the detection of sub-centimeter polyps.
However, the investigators have shown that a recent computer-aided detection system (CADe) such as the ENDO-AID software in combination with the EVIS X1 video column (Olympus, Tokyo, Japan) may present difficulties in the detection of flat lesions such as sessile serrated lesions (SSLs) and non-granular laterally spreading tumors (LST-NGs).
This represents a major challenge because in addition to their shape being difficult to identify for the human eye in practice and where AI assistance would be of great value, these rare lesions are associated with advanced histology.
In addition, the investigators recently described the case of a worrisome false negative of AI-assisted colonoscopy, which failed to detect a flat adenocarcinoma in the transverse colon.
Therefore, it is important to measure the false negative rate of AI detection based on the macroscopic shape of the lesion. Comparing this rate to the human endoscopist's false negatives would improve the performance of AI for this specific lesion subtype in the future.
- Conditions
- Flat Colorectal Lesion
- Being tested
- proportion of colorectal lesions
- Keywords
- detection, AI, CAD, colorectal cancer, LST, adenoma, SSL
- Medical subject headings
- Colorectal Neoplasms, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
proportion of colorectal lesionsProcedure or surgery
Evaluation of the proportion of colorectal lesions detected by a computer-aided detection system (CADe) compared with experienced endoscopists.
| Study group | Role | What they receive |
|---|---|---|
| Colorectal lesion diagnostic | Every patient referred to our center for colorectal endoscopy for investigation and/or resection of colorectal lesion can join the cohort of this study and will benefit from diagnosis and treatment by experienced endoscopists. Receives: Procedure: proportion of colorectal lesions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the proportion of colorectal lesions
Evaluation of the proportion of colorectal lesions detected by a computer-aided detection system (CADe) compared with experienced endoscopists and correlation with final histology reading.
Measured: Time point can be reached either 2 weeks after endoscopic resection or between 2-4 months later in case of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start1 Jan 2022
- Primary completion1 Jun 2022
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flat Colorectal LesionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942677
- Sponsor's protocol ID
- 69HCL21_1366
- Acronym
- AIChallengeMed
- Status last verified
- Jul 2023
- First submitted
- 4 Jul 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Flat Colorectal Lesion Detection by Artificial Intelligence-assisted Colonoscopy Versus Endoscopists: AIChallenge - Medtronic
- ClinicalTrials.gov ID
- NCT05942677
- Acronym / sponsor ID
- AIChallengeMed / 69HCL21_1366
- Conditions
- Flat Colorectal Lesion
- Keywords
- detection, AI, CAD, colorectal cancer, LST, adenoma, SSL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 12 Jul 2023 (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.
The development of artificial intelligence (AI) systems in the field of colorectal endoscopy is currently booming, colorectal cancer being, by its frequency and severity, a real public health problem.
In terms of image analysis, AI is indeed able to perform many tasks simultaneously (lesion detection, classification, and segmentation) and to combine them.
Lesion detection is thus the starting point of the whole chain to choose at the end the most appropriate treatment for the patient. Large-scale studies have demonstrated the superiority of artificial intelligence-assisted detection over the usual detection by gastroenterologists, mainly for the detection of sub-centimeter polyps.
However, the investigators have shown that a recent computer-aided detection system (CADe) such as the ENDO-AID software in combination with the EVIS X1 video column (Olympus, Tokyo, Japan) may present difficulties in the detection of flat lesions such as sessile serrated lesions (SSLs) and non-granular laterally spreading tumors (LST-NGs).
This represents a major challenge because in addition to their shape being difficult to identify for the human eye in practice and where AI assistance would be of great value, these rare lesions are associated with advanced histology.
In addition, the investigators recently described the case of a worrisome false negative of AI-assisted colonoscopy, which failed to detect a flat adenocarcinoma in the transverse colon.
Therefore, it is important to measure the false negative rate of AI detection based on the macroscopic shape of the lesion. Comparing this rate to the human endoscopist's false negatives would improve the performance of AI for this specific lesion subtype in the future.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colorectal lesion diagnostic | – | Procedure: proportion of colorectal lesionsEvery patient referred to our center for colorectal endoscopy for investigation and/or resection of colorectal lesion can join the cohort of this study and will benefit from diagnosis and treatment by experienced endoscopists. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every patient referred to our center for colorectal endoscopy for investigation and/or resection of colorectal lesion can join the cohort of this study and will benefit from diagnosis and treatment by experienced endoscopists.
Key inclusion criteria (5 listed)
- both gender patients even or older than 18 years old
- patient with French Health Insurance coverage
- obtaining of oral non opposition to research after loyal, clear and complete delivery of information
- patients addressed to our center for colorectal lesion resection
- patients presenting a colorectal lesion discovered during a diagnostic colonoscopy
Key exclusion criteria (6 listed)
- patients with health disorders needing short procedure times
- patients with no colorectal lesion
- difficulty continuing colonoscopy due to poor sedation
- difficulty continuing colonoscopy due to a serious adverse event
- inappropriate participation after colonoscopy is completed
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 |
|---|---|---|
| proportion of colorectal lesionsEvaluation of the proportion of colorectal lesions detected by a computer-aided detection system (CADe) compared with experienced endoscopists. | Procedure or surgery | Colorectal lesion diagnostic |
Primary outcome
Evaluation of the proportion of colorectal lesions
Time frame: Time point can be reached either 2 weeks after endoscopic resection or between 2-4 months later in case of surgery
Evaluation of the proportion of colorectal lesions detected by a computer-aided detection system (CADe) compared with experienced endoscopists and correlation with final histology reading.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
Related trials for Flat Colorectal Lesion
Active, not recruiting
Endoscopic Mucosal Resection Versus Endoscopic Submucosal Dissection for Colorectal Laterally Spreading Lesions.
Neoplasms, Colorectal
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 Flat Colorectal Lesion, run by Hospices Civils de Lyon at 1 site in France.
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 6 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 13 Nov 2023. 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 France. 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?
Evaluation of the proportion of colorectal lesions (time frame: Time point can be reached either 2 weeks after endoscopic resection or between 2-4 months later in case of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Nov 2023.