Colon CancerAIRCOPNCT06216405
Performance of Artificial Intelligence in Colonoscopy for Right Colon Polyp Detection
A study testing Colonoscopy in people with Colon Cancer and Colon Polyp, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 1 site in France.
Trial summary
The aim of the study is to assess whether the use of artificial intelligence improves polyp detection in a segment of the colon (the right colon). To achieve this objective, patients will be divided into two groups: one will undergo a standard colonoscopy, the other a colonoscopy with the artificial intelligence… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Colon Polyp, Colon Lesion
- What is being tested?
- Colonoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteFrance
- Study dates
- 20 Jan 2022to 3 Jan 2024
- Phase
- Interventional
- 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
Who may be able to join
- Age>18 years
- Signed informed consent
- Affiliated to or beneficiary of a social security scheme
Who cannot join
- Patients with history of inflammatory bowel diseases
- Patients with history of familial polyposis syndrome
- Patients with history of right colonic resection.
- Pregnant or breastfeeding women
- Patient benefiting from a legal protection measure : tutorship, curatorship, patient deprived of freedom
- Adults who are unable to give their consent
- People under psychiatric care who are not able to understand the aim if this research
Trial locations and contacts
1 site in 1 country.
France1 site
Groupe Hospitalier Diaconesses Croix Saint-Simon
Paris, Île-de-France Region, 75020
About this study
Official title: Performance of Artificial Intelligence in Colonoscopy for Right Colon Polyp Detection: a Randomized Controlled Trial
The aim of the study is to assess whether the use of artificial intelligence improves polyp detection in a segment of the colon (the right colon).
To achieve this objective, patients will be divided into two groups: one will undergo a standard colonoscopy, the other a colonoscopy with the artificial intelligence software connected to the machine.
Read more
This software does not modify the colonoscopy technique in any way, and does not require the administration of any product to the patient.
The study will compare the detection rate of right colon polyps between the group of patients who underwent standard colonoscopy and those who underwent colonoscopy with artificial intelligence. If this number does not differ between the two groups, the investigators can conclude that there is no point in using artificial intelligence.
Read the detailed description
Colorectal cancer (CRC) is the third most common cancer and remains one of the leading causes of mortality among neoplastic diseases in the world. Screening colonoscopy with detection and resection of colorectal polyps have reduced CRC incidence and mortality.
Nevertheless, colonoscopy is an imperfect screening test and its effectiveness is influenced by a range of variables including the skill and expertise of the endoscopist. Indeed, a significant proportion of colorectal neoplasia is missed during colonoscopic examinations. In the majority of studies, the rate of interval CRC among all CRCs ranged from 2% to 9% and interval cancers occurred more likely in the right colon. Interval cancers can result from missed lesion, incomplete removal or newly developed cancer. Most missed polyps are smaller than 10 mm in diameter and are sessile or flat in appearance. Therefore, sessile serrated adenomas (SSAs), which predominantly occur in the right colon, are easily missed because they are small and sessile.
Colonoscopy is less effective in screening right sided CRCs, mainly because of the increased miss rate for polyps with sessile or flat appearance. In recent years, artificial intelligence (AI) is increasingly applied in gastrointestinal endoscopy, especially in the detection of colorectal polyps. In 2019, the first prospective randomized controlled trial including 1058 patients and comparing the polyp detection rate in colonoscopy with or without AI showed a significantly higher detection rate in the group with AI (29.1% vs 20.3%). Other previous prospective studies have showed that AI had great potential for improving colonic polyp detection.
To our knowledge, this is the first study to date to evaluate the performance of the AI in the detection of right colon polyps.
In this study, the investigators aim first of all to compare the rate of right colon polyp detection with AI-aided colonoscopy (AIC) to the rate obtained by the Standard (high-definition) colonoscopy (SC) in patient undergoing diagnostic colonoscopy. Then, the investigators would to evaluate the following endpoints:
- Comparison of time required for AIC versus SC (withdrawal time)
- Comparison of histological classification of all polyps detected in each group
- Comparison of the number of right colon polyps detected in each group
- A subgroup analysis comparing the rate of colon polyp detection between the two groups will be realized according to the procedure starting time (accounting for operator fatigability).
- Conditions
- Colon Cancer, Colon Polyp, Colon Lesion, Colon Adenocarcinoma
- Being tested
- Colonoscopy
- Keywords
- Colonoscopy, Polyp detection, Artificial Intelligence
- Medical subject headings
- Colonic Neoplasms, Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColonoscopyProcedure or surgery
Colonoscopy
| Study group | Role | What they receive |
|---|---|---|
| AI-aided colonoscopy | Experimental | Experimental arm : patients receive a colonoscopy using GI Genius™ intelligent endoscopy system (Medtronic Inc., Minneapolis, Minnesota, USA) Receives: Procedure: Colonoscopy |
| Standard colonoscopy | Active comparator | Control arm :The artificial intelligence is not activated during the colonoscopy exam,the patient receive a standard high definition colonoscopy Receives: Procedure: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the percentage of patients with at least one right colon polyp detected according to the randomization group, and adjusted for Boston Bowel preparation scale, for the operator, for the endoscope and for stratification factors.
A multiple logistic regression comparing the percentage of patients with at least one right colon polyp detected according to the randomization group, and adjusted for Boston Bowel preparation scale (6-7 vs >7), for the operator, for the endoscope (Pentax or Fuji) and for stratification factors (age and polyps or CRC history).
Measured: Inclusion visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2024
- Study start20 Jan 2022
- Primary completion12 Dec 2023
- Study completion3 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized into the two groups: * Experimental : AI-aided colonoscopy using GI Genius™ intelligent endoscopy system (Medtronic Inc., Minneapolis, Minnesota, USA) * Control : Standard high-definition colonoscopy: Randomization will be established according to a 1:1 ratio, balanced and per block of variable size, and stratified according to age (≤50 vs \>50 years-old) and on personal polyps or colorectal cancer history (yes vs no)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-Simon
- Sponsor type
- University, hospital or other
- Collaborators
- Cosmo Artificial Intelligence-AI Ltd
- Responsible party
- Principal investigator, TANNOURY Jenny, Groupe Hospitalier Diaconesses Croix Saint-Simon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06216405
- Sponsor's protocol ID
- 2021-A01243-38
- Acronym
- AIRCOP
- Status last verified
- Mar 2023
- First submitted
- 11 Jan 2024
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Artificial Intelligence in Colonoscopy for Right Colon Polyp Detection: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06216405
- Acronym / sponsor ID
- AIRCOP / 2021-A01243-38
- Conditions
- Colon Cancer, Colon Polyp, Colon Lesion, Colon Adenocarcinoma
- Keywords
- Colonoscopy, Polyp detection, Artificial Intelligence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,000 participants (actual)
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-SimonUniversity, hospital or other
- Collaborators
- Cosmo Artificial Intelligence-AI Ltd
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- 3 Jan 2024 (actual)
- First posted
- 22 Jan 2024 (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 aim of the study is to assess whether the use of artificial intelligence improves polyp detection in a segment of the colon (the right colon).
To achieve this objective, patients will be divided into two groups: one will undergo a standard colonoscopy, the other a colonoscopy with the artificial intelligence software connected to the machine.
This software does not modify the colonoscopy technique in any way, and does not require the administration of any product to the patient.
The study will compare the detection rate of right colon polyps between the group of patients who underwent standard colonoscopy and those who underwent colonoscopy with artificial intelligence. If this number does not differ between the two groups, the investigators can conclude that there is no point in using artificial intelligence.
Detailed description
Colorectal cancer (CRC) is the third most common cancer and remains one of the leading causes of mortality among neoplastic diseases in the world. Screening colonoscopy with detection and resection of colorectal polyps have reduced CRC incidence and mortality.
Nevertheless, colonoscopy is an imperfect screening test and its effectiveness is influenced by a range of variables including the skill and expertise of the endoscopist. Indeed, a significant proportion of colorectal neoplasia is missed during colonoscopic examinations. In the majority of studies, the rate of interval CRC among all CRCs ranged from 2% to 9% and interval cancers occurred more likely in the right colon. Interval cancers can result from missed lesion, incomplete removal or newly developed cancer. Most missed polyps are smaller than 10 mm in diameter and are sessile or flat in appearance. Therefore, sessile serrated adenomas (SSAs), which predominantly occur in the right colon, are easily missed because they are small and sessile.
Colonoscopy is less effective in screening right sided CRCs, mainly because of the increased miss rate for polyps with sessile or flat appearance. In recent years, artificial intelligence (AI) is increasingly applied in gastrointestinal endoscopy, especially in the detection of colorectal polyps. In 2019, the first prospective randomized controlled trial including 1058 patients and comparing the polyp detection rate in colonoscopy with or without AI showed a significantly higher detection rate in the group with AI (29.1% vs 20.3%). Other previous prospective studies have showed that AI had great potential for improving colonic polyp detection.
To our knowledge, this is the first study to date to evaluate the performance of the AI in the detection of right colon polyps.
In this study, the investigators aim first of all to compare the rate of right colon polyp detection with AI-aided colonoscopy (AIC) to the rate obtained by the Standard (high-definition) colonoscopy (SC) in patient undergoing diagnostic colonoscopy. Then, the investigators would to evaluate the following endpoints:
- Comparison of time required for AIC versus SC (withdrawal time)
- Comparison of histological classification of all polyps detected in each group
- Comparison of the number of right colon polyps detected in each group
- A subgroup analysis comparing the rate of colon polyp detection between the two groups will be realized according to the procedure starting time (accounting for operator fatigability).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be randomized into the two groups: * Experimental : AI-aided colonoscopy using GI Genius™ intelligent endoscopy system (Medtronic Inc., Minneapolis, Minnesota, USA) * Control : Standard high-definition colonoscopy: Randomization will be established according to a 1:1 ratio, balanced and per block of variable size, and stratified according to age (≤50 vs >50 years-old) and on personal polyps or colorectal cancer history (yes vs no)
| Arm | Type | Receives |
|---|---|---|
| AI-aided colonoscopy | Experimental | Procedure: ColonoscopyExperimental arm : patients receive a colonoscopy using GI Genius™ intelligent endoscopy system (Medtronic Inc., Minneapolis, Minnesota, USA) |
| Standard colonoscopy | Active comparator | Procedure: ColonoscopyControl arm :The artificial intelligence is not activated during the colonoscopy exam,the patient receive a standard high definition colonoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age>18 years
- Signed informed consent
- Affiliated to or beneficiary of a social security scheme
Key exclusion criteria (7 listed)
- Patients with history of inflammatory bowel diseases
- Patients with history of familial polyposis syndrome
- Patients with history of right colonic resection.
- Pregnant or breastfeeding women
- Patient benefiting from a legal protection measure : tutorship, curatorship, patient deprived of freedom
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 |
|---|---|---|
| ColonoscopyColonoscopy | Procedure or surgery | AI-aided colonoscopy, Standard colonoscopy |
Primary outcome
Comparing the percentage of patients with at least one right colon polyp detected according to the randomization group, and adjusted for Boston Bowel preparation scale, for the operator, for the endoscope and for stratification factors.
Time frame: Inclusion visit
A multiple logistic regression comparing the percentage of patients with at least one right colon polyp detected according to the randomization group, and adjusted for Boston Bowel preparation scale (6-7 vs >7), for the operator, for the endoscope (Pentax or Fuji) and for stratification factors (age and polyps or CRC history).
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 23 Jan 2024.
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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.
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?
A study testing Colonoscopy in people with Colon Cancer and Colon Polyp, run by Groupe Hospitalier Diaconesses Croix Saint-Simon 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 3 inclusion and 7 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 23 Jan 2024. 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?
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?
Comparing the percentage of patients with at least one right colon polyp detected according to the randomization group, and adjusted for Boston Bowel preparation scale, for the operator, for the endoscope and for stratification factors. (time frame: Inclusion visit). 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 23 Jan 2024.