Lynch SyndromeNCT06654128
The Yield of Artificial Intelligence (GI Genius) in Lynch Syndrome - A Randomized Tandem-colonoscopy Trial
A study testing artificial intelligence in people with Lynch Syndrome, run by Sheba Medical Center at 1 site in Israel.
Trial summary
We aim to investigate the incremental detection rate of polyps using AI- assisted colonoscopy compared with high-definition white-light endoscopy (HD-WLE). We will conduct a single-center randomized tandem colonoscopy trial of patients with Lynch syndrome with and without AI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lynch Syndrome
- What is being tested?
- artificial intelligence
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 3 Nov 2024to 1 Nov 2025
- 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
- patients with a known pathogenic variant in one of the mismatch repair genes, who are undergoing endoscopic screening and surveillance in our institute
Who cannot join
- patients < 18 years old
- lack of informed consent
- concomitant inflammatory bowel disease
- previous total colectomy
- inadequate bowel cleansing (Boston Bowel Preparation Scale (BBPS) ≤5 or < 2 in one of the 3 segments)
Trial locations and contacts
1 site in 1 country.
About this study
We aim to investigate the incremental detection rate of polyps using AI- assisted colonoscopy compared with high-definition white-light endoscopy (HD-WLE).
We will conduct a single-center randomized tandem colonoscopy trial of patients with Lynch syndrome with and without AI. Patients will undergo tandem colonoscopy, the second colonoscopy with either HD-WLE or an AI- assisted device.
Read the detailed description
We will include patients with a known pathogenic variant (PV) / likely PV in one of the MMR genes, who are undergoing endoscopic screening and surveillance in our institute. Patients will undergo a first colonoscopy with HD-WLE, and will be randomized at 1:1 ratio to undergo a second colonoscopy with either HD-WLE or an AI- assisted device. All visualized polyps will be removed and size, histology and numbers of polyps detected on each exam will be recorded. We will evaluate the adenoma detection rate and polyp detection rate in each arm and the number of adenomas / polyps in each arm.
- Conditions
- Lynch Syndrome
- Being tested
- artificial intelligence
- Keywords
- lynch syndrome, artificial intelligence, tandem colonoscopy
- Medical subject headings
- Colorectal Neoplasms, Hereditary Nonpolyposis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
artificial intelligenceDiagnostic test
patients will undergo tandem colonoscopy with artificial intelligence
| Study group | Role | What they receive |
|---|---|---|
| high-definition white-light endoscopy | No intervention | patients undergoing first and second colonoscopy with high-definition white-light endoscopy |
| artificial intelligence | Active comparator | patients undergoing first colonoscopy with high-definition white-light endoscopy and second colonoscopy with artificial intelligence Receives: Diagnostic Test: artificial intelligence |
What is being measured
The primary outcome is the main question the study is designed to answer.
adenoma incremental detection rate
per lesion analysis, the incremental detection rate will be calculated, defined as the number of lesions detected during the second colonoscopy divided by the total number of lesions detected during first and second colonoscopy combined.
Measured: From the start of the first colonoscopy until the end of the second colonoscopy, performed on the day of enrollment (both colonoscopies performed consecutively on the same day).]
Secondary outcomes (2)
incremental detection rate for advanced neoplasia and any polyp
per lesion analysis, the incremental detection rate for advance neoplasia and any polyp. In the per patient analysis, the increment in adenoma detection rate and any polyp detection rate.
Measured: From the start of the first colonoscopy until the end of the second colonoscopy, performed on the day of enrollment (both colonoscopies performed consecutively on the same day).]
The increment in adenoma detection rate / polyp detection rate
per lesion analysis, the incremental detection rate for advance neoplasia and any polyp. In the per patient analysis, the increment in adenoma detection rate and any polyp detection rate.
Measured: From the start of the first colonoscopy until the end of the second colonoscopy, performed on the day of enrollment (both colonoscopies performed consecutively on the same day).]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start3 Nov 2024
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lynch SyndromeStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- comparison of 2 groups of patients undergoing tandem colonoscopy
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654128
- Sponsor's protocol ID
- SHEBA-20-6956-IL-CTIL
- Status last verified
- Apr 2026
- First submitted
- 21 Oct 2024
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Yield of Artificial Intelligence (GI Genius) in Lynch Syndrome - A Randomized Tandem-colonoscopy Trial
- ClinicalTrials.gov ID
- NCT06654128
- Acronym / sponsor ID
- SHEBA-20-6956-IL-CTIL
- Conditions
- Lynch Syndrome
- Keywords
- lynch syndrome, artificial intelligence, tandem colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 3 Nov 2024 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 23 Oct 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.
We aim to investigate the incremental detection rate of polyps using AI- assisted colonoscopy compared with high-definition white-light endoscopy (HD-WLE).
We will conduct a single-center randomized tandem colonoscopy trial of patients with Lynch syndrome with and without AI. Patients will undergo tandem colonoscopy, the second colonoscopy with either HD-WLE or an AI- assisted device.
Detailed description
We will include patients with a known pathogenic variant (PV) / likely PV in one of the MMR genes, who are undergoing endoscopic screening and surveillance in our institute. Patients will undergo a first colonoscopy with HD-WLE, and will be randomized at 1:1 ratio to undergo a second colonoscopy with either HD-WLE or an AI- assisted device. All visualized polyps will be removed and size, histology and numbers of polyps detected on each exam will be recorded. We will evaluate the adenoma detection rate and polyp detection rate in each arm and the number of adenomas / polyps in each arm.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- comparison of 2 groups of patients undergoing tandem colonoscopy
| Arm | Type | Receives |
|---|---|---|
| high-definition white-light endoscopy | No intervention | –patients undergoing first and second colonoscopy with high-definition white-light endoscopy |
| artificial intelligence | Active comparator | Diagnostic Test: artificial intelligencepatients undergoing first colonoscopy with high-definition white-light endoscopy and second colonoscopy with artificial intelligence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with a known pathogenic variant in one of the mismatch repair genes, who are undergoing endoscopic screening and surveillance in our institute
Key exclusion criteria (5 listed)
- patients < 18 years old
- lack of informed consent
- concomitant inflammatory bowel disease
- previous total colectomy
- inadequate bowel cleansing (Boston Bowel Preparation Scale (BBPS) ≤5 or < 2 in one of the 3 segments)
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 |
|---|---|---|
| artificial intelligencepatients will undergo tandem colonoscopy with artificial intelligence | Diagnostic test | artificial intelligence |
Primary outcome
adenoma incremental detection rate
Time frame: From the start of the first colonoscopy until the end of the second colonoscopy, performed on the day of enrollment (both colonoscopies performed consecutively on the same day).]
per lesion analysis, the incremental detection rate will be calculated, defined as the number of lesions detected during the second colonoscopy divided by the total number of lesions detected during first and second colonoscopy combined.
2 secondary outcomes
incremental detection rate for advanced neoplasia and any polyp
Time frame: From the start of the first colonoscopy until the end of the second colonoscopy, performed on the day of enrollment (both colonoscopies performed consecutively on the same day).]
The increment in adenoma detection rate / polyp detection rate
Time frame: From the start of the first colonoscopy until the end of the second colonoscopy, performed on the day of enrollment (both colonoscopies performed consecutively on the same day).]
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 20 Apr 2026.
- Individual participant dataSharing planned: No
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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 artificial intelligence in people with Lynch Syndrome, run by Sheba Medical Center at 1 site in Israel.
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 1 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: finished, as of the sponsor's last update on 20 Apr 2026. 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 Israel. 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?
adenoma incremental detection rate (time frame: From the start of the first colonoscopy until the end of the second colonoscopy, performed on the day of enrollment (both colonoscopies performed consecutively on the same day).]). 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 20 Apr 2026.