Lynch SyndromeCADLYNCHNCT05963191
CAD-EYE System for the Detection of Neoplastic Lesions in Patients With Lynch Syndrome
A study testing Colorectal cancer screening with CAD EYE colonoscopy in people with Lynch Syndrome, run by PERROD Guillaume at 1 site in France.
Trial summary
Lynch syndrome (LS) is the most common genetic predisposition syndrome for colorectal cancer (CRC), responsible for around 2-4% of cancers. It is characterized by a pathogenic germline mutation in one of the DNA mismatch repair genes (path_MMR) MLH1, MSH2, MSH6, PMS2 or a deletion in the 3' region of the Epcam gene. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lynch Syndrome
- What is being tested?
- Colorectal cancer screening with CAD EYE colonoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteFrance
- Study dates
- 18 Apr 2024to 18 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed pathogenic mutation (path_MLH1, path_MSH2, path_MSH6, path_PMS2, path_EpCAM)
- Male or female of legal age at time of colonoscopy prescription.
- Patient agreeing to participate in the study
- Person affiliated with or benefiting from a social security scheme
- Free, informed and express consent
Who cannot join
- Patient undergoing total colectomy with ileoanal or ileosigmoid anastomosis
- Patient with a history of Crohn's disease or ulcerative colitis
- Patients with a known allergy or intolerance to polyethylene glycol and ascorbic acid.
- Patients unable to undergo fractionated colonic preparation
- Inadequate colonic preparation: Boston sub-score <2 per segment
- Patient under guardianship or protected person
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- Patient who does not understand French or cannot read
- Person not affiliated to a Social Security system.
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Européen Georges-Pompidou HEGP
Paris, 75015
Guillaume Perrod, MD
About this study
Official title: Evaluation of the CAD-EYE System for the Detection of Colorectal Neoplastic Lesions in Patients With Lynch Syndrome
Lynch syndrome (LS) is the most common genetic predisposition syndrome for colorectal cancer (CRC), responsible for around 2-4% of cancers. It is characterized by a pathogenic germline mutation in one of the DNA mismatch repair genes (path_MMR) MLH1, MSH2, MSH6, PMS2 or a deletion in the 3' region of the Epcam gene. Patients followed up for LS are at high risk of developing CRC at an early age, and have a high cumulative CRC risk. In this context, CRC screening by colonoscopy is of major importance, as it is associated with a reduction in both CRC incidence and mortality.
In France, the Institut National du Cancer (INCa) recommends colonoscopy with indigo carmine chromoendoscopy (CE), as it is associated with a significant increase in the adenoma detection rate (ADR) compared with white light. However, EC is not routinely performed in clinical practice, as it is a time-consuming technique requiring a dedicated slot with a trained operator.
Read more
Recent years have seen the emergence of artificial intelligence techniques for real-time polyp detection aids or CADe devices. These easy-to-use systems have shown very promising results compared with high-definition (HD) white light. Indeed, data from the first meta-analysis of 5 randomized controlled trials (4354 patients) confirmed a significantly higher ADD in the CADe group than in the HD group (36.6% vs. 25.2%; 95% CI], 1.27-1.62; P < 0.01; I2 Z 42%) 10. The CAD EYE system (Fujifilm) is a CADe device supporting both detection (sensitivity > 95%) and characterization of colonic polyps in real time.
To date, artificial intelligence has never been evaluated for CRC screening in patients followed up for LS. The aim of this work is to evaluate the effectiveness of the CAD EYE system in this specific population. To this end, we intend to conduct a randomized, controlled, non-inferiority trial comparing CAD EYE with CE in patients with LS.
- Conditions
- Lynch Syndrome
- Being tested
- Colorectal cancer screening with CAD EYE colonoscopy
- Keywords
- Lynch Syndrome, CAD EYE, adenoma detection rate, colorectal screening, artificial intelligence
- 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.
Colorectal cancer screening with CAD EYE colonoscopyDevice
The colonoscopy procedure for each patient will be no different from a conventional colonoscopy examination. A colonoscopy is considered complete if the endoscope reaches the appendicular orifice or the terminal ileum. In line with recommendations, water lavage (using a lavage pump) and aspiration of food residues will be performed on ascent and/or descent to visualize the entire colonic mucosa.
In the CAD EYE group, descent is performed under white light, with the CAD EYE system switched on. When polyps are detected, they are rigorously described and histological predictions of endoscopist and CAD EYE will be reported separately. Then polyps will be removed by polypectomy or mucosectomy. Removed polyps are then sent for anatomopathological analysis.
| Study group | Role | What they receive |
|---|---|---|
| CAD-EYE group: Colorectal cancer screening with CAD EYE colonoscopy | Experimental | The colonoscopy procedure for each patient will be no different from a conventional colonoscopy examination. In the CAD EYE group, descent is performed under white light, with the CAD EYE system switched on (device with CE mark). When polyps are detected, they are rigorously described and histological predictions of endoscopist and CAD EYE will be reported separately. Receives: Device: Colorectal cancer screening with CAD EYE colonoscopy |
| CE group : Colorectal cancer screening with indigo carmine chromo colonoscopy | No intervention | The colonoscopy procedure for each patient will be no different from a conventional colonoscopy examination. In the CE group, descent is performed under white light with indigo carmin chromoendoscopy (0.4%) applied through a catheter spray. When polyps are detected, they are rigorously described and histological prediction of the endoscopist reported. |
What is being measured
The primary outcome is the main question the study is designed to answer.
to evaluate the effectiveness of the CAD EYE system in screening for neoplastic lesions in Lynch syndrome.
Comparison of the adenoma detection rate (ADR) between the CAD-EYE group and the indigo carmin chromoendoscopy (CE) group (reference technique).
Measured: Through study completion, an average of 2 years
Secondary outcomes (4)
Detection rates of specific lesions
Mean number of adenomas and serrated lesions per patient
Measured: Through study completion, an average of 2 years
Diagnostic performance of CAD EYE
Comparison of the diagnostic performance of CAD EYE assessed by specificity, negative predictive value and positive predictive value for the characterization (adenoma/hyperplastic) of colonic polyps with the CAD EYE automated detection system. The anatomopathology of polyps was taken as the diagnostic reference.
Measured: Through study completion, an average of 2 years
Rate of resect and discard strategy
Evaluation of the feasibility of a "resect and discard" strategy in Lynch Syndrome. Retrospective analysis comparing CAD-EYE histological prediction vs. endoscopist prediction, using histological report as reference examination (Sensitivity and negative predictive value).
Measured: Through study completion, an average of 2 years
Time of Colonoscopies
Comparison of different procedure times between the 2 groups. Total procedure time will be defined as the time from endoscope insertion to extraction through the anus. Withdrawal time will be defined as the time spent on inspection, from the cecum to extraction of the endoscope through the anus, excluding the time required for polypectomy.
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start18 Apr 2024
- Primary completion18 Apr 2025
- Study completion18 Apr 2026 (estimated)
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.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PERROD Guillaume
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, PERROD Guillaume, French Society of Digestive Endoscopy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963191
- Sponsor's protocol ID
- SFED 156
- Acronym
- CADLYNCH
- Status last verified
- Sep 2025
- First submitted
- 10 Jul 2023
- Last updated
- 3 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the CAD-EYE System for the Detection of Colorectal Neoplastic Lesions in Patients With Lynch Syndrome
- ClinicalTrials.gov ID
- NCT05963191
- Acronym / sponsor ID
- CADLYNCH / SFED 156
- Conditions
- Lynch Syndrome
- Keywords
- Lynch Syndrome, CAD EYE, adenoma detection rate, colorectal screening, artificial intelligence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- PERROD GuillaumeUniversity, hospital or other
- Study start
- 18 Apr 2024 (actual)
- Primary completion
- 18 Apr 2025 (actual)
- Study completion
- 18 Apr 2026 (estimated)
- First posted
- 27 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.
Lynch syndrome (LS) is the most common genetic predisposition syndrome for colorectal cancer (CRC), responsible for around 2-4% of cancers. It is characterized by a pathogenic germline mutation in one of the DNA mismatch repair genes (path_MMR) MLH1, MSH2, MSH6, PMS2 or a deletion in the 3' region of the Epcam gene. Patients followed up for LS are at high risk of developing CRC at an early age, and have a high cumulative CRC risk. In this context, CRC screening by colonoscopy is of major importance, as it is associated with a reduction in both CRC incidence and mortality.
In France, the Institut National du Cancer (INCa) recommends colonoscopy with indigo carmine chromoendoscopy (CE), as it is associated with a significant increase in the adenoma detection rate (ADR) compared with white light. However, EC is not routinely performed in clinical practice, as it is a time-consuming technique requiring a dedicated slot with a trained operator.
Recent years have seen the emergence of artificial intelligence techniques for real-time polyp detection aids or CADe devices. These easy-to-use systems have shown very promising results compared with high-definition (HD) white light. Indeed, data from the first meta-analysis of 5 randomized controlled trials (4354 patients) confirmed a significantly higher ADD in the CADe group than in the HD group (36.6% vs. 25.2%; 95% CI], 1.27-1.62; P < 0.01; I2 Z 42%) 10. The CAD EYE system (Fujifilm) is a CADe device supporting both detection (sensitivity > 95%) and characterization of colonic polyps in real time.
To date, artificial intelligence has never been evaluated for CRC screening in patients followed up for LS. The aim of this work is to evaluate the effectiveness of the CAD EYE system in this specific population. To this end, we intend to conduct a randomized, controlled, non-inferiority trial comparing CAD EYE with CE in patients with LS.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAD-EYE group: Colorectal cancer screening with CAD EYE colonoscopy | Experimental | Device: Colorectal cancer screening with CAD EYE colonoscopyThe colonoscopy procedure for each patient will be no different from a conventional colonoscopy examination. In the CAD EYE group, descent is performed under white light, with the CAD EYE system switched on (device with CE mark). When polyps are detected, they are rigorously described and histological predictions of endoscopist and CAD EYE will be reported separately. |
| CE group : Colorectal cancer screening with indigo carmine chromo colonoscopy | No intervention | –The colonoscopy procedure for each patient will be no different from a conventional colonoscopy examination. In the CE group, descent is performed under white light with indigo carmin chromoendoscopy (0.4%) applied through a catheter spray. When polyps are detected, they are rigorously described and histological prediction of the endoscopist reported. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed pathogenic mutation (path_MLH1, path_MSH2, path_MSH6, path_PMS2, path_EpCAM)
- Male or female of legal age at time of colonoscopy prescription.
- Patient agreeing to participate in the study
- Person affiliated with or benefiting from a social security scheme
- Free, informed and express consent
Key exclusion criteria (9 listed)
- Patient undergoing total colectomy with ileoanal or ileosigmoid anastomosis
- Patient with a history of Crohn's disease or ulcerative colitis
- Patients with a known allergy or intolerance to polyethylene glycol and ascorbic acid.
- Patients unable to undergo fractionated colonic preparation
- Inadequate colonic preparation: Boston sub-score <2 per segment
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 |
|---|---|---|
| Colorectal cancer screening with CAD EYE colonoscopyThe colonoscopy procedure for each patient will be no different from a conventional colonoscopy examination. A colonoscopy is considered complete if the endoscope reaches the appendicular orifice or the terminal ileum. In line with recommendations, water lavage (using a lavage pump) and aspiration of food residues will be performed on ascent and/or descent to visualize the entire colonic mucosa. In the CAD EYE group, descent is performed under white light, with the CAD EYE system switched on. When polyps are detected, they are rigorously described and histological predictions of endoscopist and CAD EYE will be reported separately. Then polyps will be removed by polypectomy or mucosectomy. Removed polyps are then sent for anatomopathological analysis. | Device | CAD-EYE group: Colorectal cancer screening with CAD EYE colonoscopy |
Primary outcome
to evaluate the effectiveness of the CAD EYE system in screening for neoplastic lesions in Lynch syndrome.
Time frame: Through study completion, an average of 2 years
Comparison of the adenoma detection rate (ADR) between the CAD-EYE group and the indigo carmin chromoendoscopy (CE) group (reference technique).
4 secondary outcomes
Detection rates of specific lesions
Time frame: Through study completion, an average of 2 years
Diagnostic performance of CAD EYE
Time frame: Through study completion, an average of 2 years
Rate of resect and discard strategy
Time frame: Through study completion, an average of 2 years
Time of Colonoscopies
Time frame: Through study completion, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colorectal cancer screening with CAD EYE colonoscopy in people with Lynch Syndrome, run by PERROD Guillaume 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 9 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: looking for participants now, as of the sponsor's last update on 3 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume Perrod, MD (+33 1 56 09 34 17, guillaume.perrod@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to evaluate the effectiveness of the CAD EYE system in screening for neoplastic lesions in Lynch syndrome. (time frame: Through study completion, an average of 2 years). 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 3 Sep 2025.